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List of Studies

The table below shows the current NIMH studies, both released and in-process. For in-process studies that are not yet released for distribution, the table shows the expected number of subjects, marked with an orange superscript.

Study Title Distributions PIs Grants Sites Subjects GWAS Notes
0 NIMH Bipolar Genetics Initiative Bipolar Disorder NURNBERGER

5U01MH046282, 5U01MH046280, 5U01MH046274

10, 12 1353

PIs: Nurnberger, Reich, DePaulo, Gershon Sites: 10-13 175 in dbGaP BP GAIN; 112 in NIMH BP-DS11 phase1; 174 in NIMH BP-DS11 phase2

0 NIMH Schizophrenia Genetics Initiative Schizophrenia CLONINGER, KAUFMANN, TSUANG

5U01MH046318, 5U01MH046276, 5U01MH046289

30, 31, 32 877

0 NIMH Alzheimers Genetics Initiative Alzheimer's Disease ALBERT, BASSETT, GO

5U01MH046281, 5U01MH046290, 5U01MH046373

50, 51, 52 1411

1 A Collaborative Genomic Study of Bipolar Disorder Bipolar Disorder BERRETTINI, BYERLEY, CORYELL, DEPAULO, NURNBERGER

R01MH059545

20, 21, 22, 23, 24, 25, 26, 28, 29 1880

2953 subjects released across BP dist 2, 4, and 8. Last release dist 8.01 04-May-2015

2 Molecular Genetics of Bipolar Disorder Bipolar Disorder BARON

R01MH059602

15, 16 843

Site 15-US; Site 16-Israel 1072 subjects released in BP dist 3.0 - release date recorded (2006-01-01) is an estimate

3 Genetic Linkage Study of Schizophrenia Schizophrenia TSUANG

R01MH059624

34, 35 2328

Site 34-China; Site 35-Taiwan. 2622 subjects released in SZ dist 2.0.

4 Collaborative Linkage Study of Autism Autism FOLSTEIN, PIVEN

R01MH055135

60, 61, 89 652

746 individuals released in autism dist 3.0. release date above (2007-01-01) is an estimate

6 Molecular Genetics of Schizophrenia Schizophrenia BYERLEY, CLONINGER, GEJMAN

R01MH059571

40, 41, 42, 43, 44, 45, 46, 47, 48, 49 1383

2041 inds released in SZ dist 3.0 on 03-Aug-2007

7 Genetics of Early-Onset Major Depression Depression DEPAULO, WEISSMAN, ZUBENKO

R01MH060912

80, 81, 82, 83, 84, 85 2238

8 Genetic Analysis of Bipolar Disorder Bipolar Disorder PATO

R01MH058693

38 223

342 inds released in BP dist 4.0 on 31-Jul-2007

9 A study of Schizophrenia Schizophrenia BERMAN, WEINBERGER

39 830

2019-07-02, SW: Study requested samples from RUCDR. Study was informed that we are missing data on ~3,965 samples (a more accurate number would be the amount of subjects in the event that we have more than one sample on one individual, which might be ~4,769). NIMH asked that study/PI give a timeline for data submission before releasing samples. Study stated, "By the end of the summer 300 participants. Approximately 100/month thereafter." NIMH approved sample request given this information. 830 inds released in SZ dist 12.0 This is an IRP study protocol. Original PI was Egan, then Weinberger, the most recent PI on record for it is Dr. Karen Faith Berman. Contact: Phone: +1 301 496 7603; Fax: +1 301 480 7795; bermank@mail.nih.gov). As an IRP study they don?t have an end date. The protocol is ongoing. There were at least 3000 samples as of 2015. We expect 5-10 samples a year. We should be receiving data from those samples within 6 months of submission. Periodic releases would be expected. We expect to get the same individual level data that we received on prior samples. There is genomic data on these samples that should be available through dbGaP or other sources. There is EEG, MEG and MRI data for some of these subjects which may be at NDA or another database. We should ask for links to any data stored somewhere else publicly.

10 Collaborative Linkage Study in Autism Autism FOLSTEIN

R01MH055135

62 4

4 individuals released in Autism dist 3.0. Release date above (2007-01-01) is an estimate

12 Genetic Analysis of Psychosis Schizophrenia PATO

R01MH052618

33 233

374 inds released in SZ 4.0 on 01-Sep-2007

13 Genetics of Schizophrenia in Latino Populations Schizophrenia CANIVE, ESCAMILLA, RAVENTOS

R01MH060881

17, 53, 54, 55, 56, 57, 58, 59 1241

14 Molecular Genetics of Infantile Autism Autism RISCH

R01MH052708

63 563

719 inds released in Autism 2.0. Release date above (2006-01-01) is an estimate

15 A Neurobehavioral Family Study of Schizophrenia Schizophrenia NIMGAONKAR

R01MH042191

70, 71 645

Released in SZ Dist. 5.0; Future Action: WU plans to process the data from this study. We will report on our progress in December.

16 Collaborative OCD Genetic Study Obsessive-Compulsive Disorder NESTADT

R01MH050214

164, 64, 65, 66, 67, 68, 69 1351

17 CLINICAL ANTIPSYCHOTIC TRIALS OF INTERVENTION EFFECTIVES (CATIE); Replication of Schizophrenia Associations in CATIE Schizophrenia LIEBERMAN, SULLIVAN

N01MH090001, R01MH074027

75, 76 741

741 inds from Site 76 (SZ) released in Schizophrenia 4.0 on 01-Sep-2007; 185 inds from Site 75 (AD) released in AD Dist. 3.0 on 10-Mar-2010 Project start date listed for N01MH090001; Project end date listed for R01MH074027 22-Jul-2019 BGR: Added NDA collection numbers (different for AZ and SZ)

18 Sequenced Treatment Alternatives to Relieve Depression (STAR*D) Depression RUSH

N01MH090003

77 1942

site 77 - 1942 inds released in Depression 2.0

19 Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD) Bipolar Disorder NIMGAONKAR

N01MH080001

14, 78, 86, 88 1829

Site 88=Controls, site 86=Relatives

20 Treatment of Adolescents with Depression (TADS) Depression MARCH

contract RFP-NIH-NIMH 98-DS-0008

79 171

171 inds released in Depression 5.0 ClinicalTrials.gov Identifier: NCT00006286 site 79 22-Jul-2019 BGR: Added NDA collection number and title

21 AGRE; A Genomewide Search for Autism Susceptibility Loci Autism GESCHWIND

R01MH064547

72, 74 3909

22 Project among African-Americans to explore risks for schizophrenia (PAARTNERS) Schizophrenia GO, NIMGAONKAR

R01MH066181

101, 102, 103, 104, 105, 106, 107, 108, 109 1739

23 Genetic Susceptibility in Schizophrenia Schizophrenia NIMGAONKAR

R01MH056242

73 384

24 Genetics of Anorexia Nervosa Anorexia Nervosa BERRETTINI, HALMI, KAYE

R01MH066122

110, 111, 112, 113, 114, 115, 116, 117, 118, 119, 120 1205

25 International Multi-Center ADHD Genetics Project (IMAGE) Attention-Deficit Hyperactivity Disorder FARAONE

R01MH062873

19, 90, 91, 92, 93, 94, 95, 96, 97, 98, 99 4959

27 The Genetics of Endophenotypes and Schizophrenia (COGS) Schizophrenia BRAFF

R01MH065571

122, 123, 124, 125, 126, 127, 128, 253, 254, 255, 256, 257 1347

COGS1 (sites 122-128) released in SZ Dist. 14.0; COGS2 (sites 253-257) still need data

28 A study of ADHD (CHOP) Attention-Deficit Hyperactivity Disorder ELIA

5K23MH066275-05

130 1500

Sherri contacted Elia (who is in private practice now - Linda found her email via google) - but no response. Gillian contacted John because they had sent phenotypic data on 200 individuals, but the updated distribution file they had sent (but we did not publish) had 1241 entries with 1229 biosamples. What little data they were able to generate for this file came from what they found at PGC. Sherri was going to see if Elia could provide the fields we typically try to require from studies who don't follow the submission packet (Sherri has these from other studies we have done this with, but I can provide again if need be).

29 Molecular Genetics of Schizophrenia Schizophrenia BYERLEY, GEJMAN

R01MH059571

139, 140, 141, 142, 143, 144, 145, 146, 147, 148, 149, 150 4362

Site 150=Controls

30 A study of Autism Autism RODIER

1P50HD055753-01, 5U19HD035466-08

158 50

52 inds released in Autism 5.0 start and end dates estimated based on samples received dates site 158 25-Feb-2019 BGR: Per Tara and Lora, "Study 30: Patricia M. Rodier Study 31 PI: Unknown Grant Numbers: 1P50HD055753-01 & 5U19HD035466-08 Please note that we could not determine which grant belongs to which study. ACTION? Enter both grant numbers for both studies, make a note in the ?notes? field."

31 A study of Autism Autism RODIER

1P50HD055753-01, 5U19HD035466-08

151 79

79 inds released in Autism 5.0 site 151 25-Feb-2019 BGR: Per Tara and Lora: "Study 30: Patricia M. Rodier Study 31 PI: Unknown Grant Numbers: 1P50HD055753-01 & 5U19HD035466-08 Please note that we could not determine which grant belongs to which study. ACTION? Enter both grant numbers for both studies, make a note in the ?notes? field."

32 A study of Autism Autism SZATMARI

152 483

598 inds Released in Autism Dist 5.0 on 01-Jun-2008 Start date and end date estimates based on first and last samples received

33 Longitudinal Study of Language and Theory of Mind in Autism Autism TAGER-FLUSBERG

P01DC003610, 3U19DC003610-08S1

153 210

34 Neurobiology and Genetics of Autism Autism DAWSON

U19HD035465

154 214

35 Molecular and Genetic Epidemiology of Autism Autism PERICAK-VANCE

R01MH080647

155 1221

36 A study of Autism Autism MCINNES

156 310

332 inds released in Autism Dist 5.0 on 01-Jun-2008. Project start date and end date estimates based on first and last samples received

37 Research Units of Pediatric Psychopharmacology (RUPP-PI) Autism MCDOUGLE

U10MH066766

157 133

39 New Jersey Language & Autism Genetics Study (NJLAGS) Autism BRZUSTOWICZ

RC1MH088288

161 391

Released in AU Dist. 13.0

40 Bipolar Genome Study (BiGS) Bipolar Disorder BERRETTINI, BYERLEY, CORYELL, MCINNIS, NURNBERGER

P50CA89392, K02DA021237

170, 171, 172, 173, 174, 175, 176, 177, 178, 179, 180, 181 3934

3934 inds released in Bipolar 5.0 on 22-Jun-2009 P50CA89392 from the National Cancer Institute; K02DA021237 from the National Institute of Drug Abuse ClinicalTrials.gov Identifier: NCT00001174 National Institute of Mental Health (NIMH) Intramural Research Program Project start date and end date estimate based on first sample received and last sample received

41 The Development of the Siblings of Children with Autism: A Longitudinal Study Autism BOOKHEIMER, PIVEN, TAGER-FLUSBERG

P50HD055784

700, 701, 702, 703, 704, 705, 706, 707 438

This study is a center grant P50HD055784, it is still ongoing in year 12, the last renewal was last year so their current incarnation lasts until 2022 and projected enrollment for this term is 531 subjects. 01-Mar-2019 BGR: deleting site 705 per instruction from Geetha 22-Jul-2019 BGR: Added NDA collection numbers and titles based on matching grant numbers

42 A Genome Wide SNP Association Study: Schizophrenia Schizophrenia PULVER

R01MH068406

185 197

43 A study of ADHD Attention-Deficit Hyperactivity Disorder TODD, TODOROV

132 800

PI deceased, new PI (todorov) locating data 26-Jul-2018 BGR - Data sent to Rutgers July 2018 by WashU team - Gillian Davis reviewing. 11-Feb-2019 BGR - adding expected # samples and subjects based on received samples; sparse study information available. Expected # subjects will be used to populate list of studies table.

44 Genetic Analysis of 15q11-q13 in Autism Autism SUTCLIFFE

R01MH061009

165 362

45 Detection of Susceptibility Genes in ADHD Attention-Deficit Hyperactivity Disorder LOO

5R01MH058277-10

135 1200

Susan Smalley (original PI retired in 2011) 11-Feb-2019 BGR - adding expected # subjects based on grant description "increase the sample size to 600 ASPs and contribute DNAs to an NIMH cell line repository for DNA sharing" 600 affected sib-pairs = 1200 expected subjects/samples Data processing - final stages WU Finish:WU will finish and distribute before the hand over

46 DM-STAT (data coordinating site for Studies 30, 31, 33, 34 & 41) DAGER

5P50HD055782-03

0

25-Feb-2019 BGR - adding filler start/end dates because they are required Per Tara Dutka & Lora Bingamon: "Unable to determine all the grant numbers for the studies. However, Pierre Dagher should be Stephen R. Dager for study 46. The grant number for study 46 should be: 5P50HD055782-03."

48 Genetic Linkage and Association in Bipolar Disorder / Amish Mennonite Bipolar Genetics Study (AmBiGen) Bipolar Disorder DEPAULO, MCMAHON

PART1: Application Number NA_00038551 (JH IRB #) / pART 2: ZIA MH002843-11 DIRP

186, 187, 188 471

Start and end dates are estimates based upon information found at http://grantome.com/grant/NIH/ZIA-MH002843-11 and due date of 2019 for part 2 found in BioQ: Future Action:Part II will be due in 2019, Rutgers will do. Part 1 released in BP Dist. 12.0 - 701 individuals

49 Genetics of Bipolar Disorder in Latino Populations Bipolar Disorder ESCAMILLA, RAVENTOS

R01MH069856

190, 191, 192, 193, 194, 195, 196, 197 2679

50 Genetics of Autism Intermediate Phenotypes Autism COON

R01MH069359

200, 201 1778

51 A study of ADHD TODD, TODOROV

121 1600

Data requested; PI deceased, new PI (todorov) locating data. WashU is supposed to complete this submission. Australia data - John Rice put us in contact with Nick Martin (Nick.Martin@qimrberghofer.edu.au) and Sarah Medland (medlandse@gmail.com) to figure out the submission. Sherri should be in touch with them to schedule a training. project start and end dates estimated based on samples received dates 11-Feb-2018 BGR - added expected # subjects and samples based on number received, sparse study information available.

52 Genetics of Early-Onset Major Depression (GenRED II) Depression CORYELL, DEPAULO, WEISSMAN

R01MH060912

280, 281, 282, 283, 284, 285, 286 1902

55 Adolescents at High Risk for Familial Bipolar Disorder Bipolar Disorder MCINNIS, NURNBERGER

R01MH068009

750, 751, 752, 753 325

56 Clinical and Immunological Investigations of Subtypes of Autism Autism AMARAL, ROGERS, VAN DE WATER

Clinical and Immunological Investigations of Subtypes of Autism

163, 208 1188

deposited demographics, family structure, ADI, ADOS, IQ summary scales

58 Genetics of Brain Structure and Function Brain Function BLANGERO, GLAHN

R01MH078111, R01MH078143

136 1480

Received data Aug 7, 2015, updates Aug 19, 2015, still need family id

59 High-Density Genome-Wide Association Study of Schizophrenia in Large Dutch Sample Schizophrenia OPHOFF

R01MH078075

100 331

60 A study of Autism Autism PIVEN

167 276

351 inds released in Autism 14.0 12-Oct-2016. Project start date estimated based on first sample received date. Project end date estimated based on due date recorded in BioQ

61 Molecular Genetic Studies of Human Anxiety Disorder Fear & Anxiety HEN

P01MH60970

137 380

Released

62 Molecular Genetic Studies of Human Anxiety Disorder Fear & Anxiety FYER

P01MH60970

138 197

197 subjects w/ samples Released in Fear & Anxiety v 1.0 11-Feb-2019 BGR - added expected # subjects, samples based on expected # biomaterials recorded below. Less than half expected received, fewer still released.

63 Interdisciplinary Studies of Insistence on Sameness in Autism Spectrum Disorders Autism COOK

P50HD055751

168 515

Released in AU Dist. 13.0 22-Jul-2019 BGR: Added NDA collection number and title based on matching grant numbers

64 Center for Genomic and Phenomic Studies in Autism Autism LAJONCHERE, ROULLET, SOHL

5U24MH081810

202, 203, 204, 205, 206, 207, 229 1263

transfer data from the AGRE Repository. Data processing - initial stages; Site 202 Released; Sites 203-207, 229 not released yet; Future Action: WU will update with most recent AGRE catalog; also see NDAR Collection #7. WAshU will finish.

65 Trio Autism Simplex Collection (TASC) Autism NURNBERGER, SZATMARI

Funded by Autism Speaks

210, 211, 212, 213, 214, 215, 216, 217, 218, 219, 220, 221 3384

dbgap list of n=7 gender discrepancies from AGP/TASC study, sent by Veronica Vieland at the AGP DCC in Columbus The TASC consortium collection and genotyping was supported by Autism Speaks. Funding for the sequencing and distribution of TASC samples was provided by the National Institutes of Health (MH094303 and MH100233). PI list: Geschwind, Szatmari, Cook, Dawson, Poustka, Gallagher, Cuccaro, Vicente, McMahon, Sutcliffe, Buxbaum, Nurnberger

66 OCD Collaborative Genetics Association Study Obsessive-Compulsive Disorder FYER, NESTADT

R01MH071507

240, 241, 242, 243, 244 3419

67 Population Based Mapping of Schizophrenia Genes Schizophrenia ESCAMILLA, RAVENTOS

R01MH061884

129 523

released in SZ distribution version19.0

68 Biological Prediction of Psychosis Susceptibility among Adolescent Cannabis Users Schizophrenia DELISI

R01DA021576

131, 18 73

Released in SZ Dist. 14.0

69 Biological and Information Processing Mechanisms Underlying Autism Autism MINSHEW

P50HD055748

209 263

Released in AU Dist. 13.0

70 Consortium for Neuropsychiatric Phenomics Research Domain Criteria BILDER

1UL1RR024911

182 2100

11-Feb-2019 BGR - Updated expected # subjects/samples fields based on information in Tara's spreadsheet, and fields expected cases + expected controls. Study Information: For Rutgers Site #182 Subjects: 2100 Expected Release: Samples and data released for sharing on an ongoing basis (12 mos. after receipt of a sample and the associated phenotype data); last sample received 1/20/2012 Disease: Neuropsychiatric Phenomics (SZ, BP, ADHD) Best way to contact: Email Dr. Bilder (PI)?s email: rbilder@mednet.ucla.edu ________________________________________________________________________ Outreach Information: 2018-07-16: In contact with PI. PI will notify NRGR if there are questions regarding his submission. -SW Update as of 5/8/2018: Waiting for the NDA call to be rescheduled to explain submission process for PI Update as of 4/11/2018: PI is traveling, will return this week and respond to inquiries Update as of 3/30/2018: Corresponding via email, issues with the University were mentioned/delaying submission ________________________________________________________________________ Phenotypic Data Submission: NDA #2499 ________________________________________________________________________ Data Sharing Details: Samples and data released for sharing on an ongoing basis (12 mos. after receipt of a sample and the associated phenotype data); last sample received 1/2012.

71 Bipolar Endophenotypes in Population Isolates Bipolar Disorder FREIMER

R01MH075007

198, 199 546

72 Preventing Relapse in Schizophrenia: Oral Antipsychotics Compared To Injectables: Evaluating Efficacy (PROACTIVE) Schizophrenia KOPELOWICZ, MANSCHRECK, MILLER

U01MH070010

261 186

Received data on 5/18/2015 22-Jul-2019 BGR: Updated title to include abbreviation, added short name, added NDA collection #

73 Combining Medications to Enhance Depression Outcomes (CO-MED) Depression KORNSTEIN, LEUCHTER, PRESKORN, ZISOOK

N01 MH090003-02

287 478

478 inds released in Depression 5.0 on 24-Oct-2014 Clinicaltrials.gov identifier NCT00590863 22-Jul-2019 BGR: Added NDA collection number and title

74 Examination of Genetic and GxE Effects in the Family and Community Health Studies (FACHS) Depression PHILIBERT

R01MH080898

133, 134 800

11-Feb-2019 BGR - updated # subjects, samples expected based on Tara spreadsheet Data received, processing and waiting for PI to clarify questions WU in contact with PI requesting answers to our queries. We plan to process and release in the next distribution (prior to the change in February). If the latency of PI response affects the release, we will alert Rutgers before the change in February.

75 Lithium Use for Bipolar Disorder: A Randomized Controlled Effectiveness Trial (LiTMUS) Bipolar Disorder IOSIFESCU, OSTACHER, THASE

Lithium Use for Bipolar Disorder: A Randomized Controlled Effectiveness Trial

189 192

192 inds released in BP dist 11.0 on 02-Nov-2015 Clinicaltrials.gov identifier NCT00667745 22-Jul-2019 BGR: added NDA collection # and title

76 Genomic Psychiatry Cohort (GPC) Schizophrenia BROMET, ESCAMILLA, MALASPINA, PATO

R01MH104964

251, 262, 263, 264, 265, 266, 267, 268, 269, 271, 351, 352, 844, 869 9784

2018/11/12: RUCDR was notified in August 2018 to destroy 2 samples due to revoked consent (MH0226581, MH0229606). Both samples were received in 2018 and no data was released for download on these subjects (last data release fro study 76 was in 2015). - BGR Added site 352-Drs. Pato/Pato moved to SUNY and Dr. Knowles took over the USC site 262; Extension of study as per Nikki 4/7/2015; will continue to submit samples using same site IDs Original grant - Grant R01 MH085548 - expected enrollment ~20,000 - ended 2013 (NCE) 2019-07-10 (LAB): Updated new grant: R01MH104964 and project end date: 01/31/2020. The NIMH PO (Dr. Tara Dutka) confirmed that the PI plans to submit a renewal application that would extend the project into 2021. Under the new grant, they have recruited ~7,000 subjects and plan to collect 5,000 more subjects over the next two years. Dr. Dutka is uncertain of the numbers the PI deposited samples from the original grant and the current grant. The estimated total for the original grant was 20,000; however, the PIs did not reach that amount. She recommended adding 5,000 to the current number of samples received, which is 22,053 as of 06/07/2019. The ~7,000 samples should have been received already as the data sharing plan states the PIs would deposit the samples as they were collected. The total number should now be 27,053.

77 International Cohort Collection for Bipolar Disorder Bipolar Disorder BROMET, ESCAMILLA, MALASPINA, SMOLLER

R01MH085542

252, 270, 272, 273, 274, 275, 304, 305, 306, 307, 308, 309, 310, 311, 312, 845, 868 4924

Added site 312-Dr. Pato moved to SUNY and Dr. Knowles took over the USC site 270 Original grant - Grant R01 MH085548 - expected enrollment ~18,000 - ended 2013 (NCE) New grant to extend studies 76 and 77 Grant- R01 MH104964-01A1- expected enrollment across 2 studies (77 and 76) ~12525 - Grant began 2015 and ends in 2020/01/31. 2019-07-10 (LAB): Recruitment from this study will depend on study 76 and whether the subjects are also consented for BPD. The total number expected is not known. This study will end when study 76 ends. Study 76's current project end is 01/31/2020, however, the PI plans to submit a renewal application that would extend the project into 2021.

78 Netherlands Twin Register Netherlands Twin Register BOOMSMA

R01D0042157-01A

169 8540

26-Jul-18 BGR: Gillian in contact with Dorret for updates to NTR dist 11991 inds released in NTR dist 1.0

79 AUTISM GENETICS: HOMOZYGOSITY MAPPING AND FUNCTIONAL VALIDATION Autism DEMMER, WALSH

R01MH085143, R01MH083565

222, 223, 224, 225, 226, 227 1064

NDAR primary deposit, see collections 2029, 2283 1169 inds released in Autism 11.0 on 23-Apr-2013 FUTURE ACTION - need to collect/release pheno data on subjects collected from 2013-2017 23-Jul-2019 BGR: Added NDA collection 1951 based on grant # match; cannot locate any NDA collection 2283 as indicated above. Typo?

80 Suicidal Behavior in Mood Disorders: Genes and Intermediate Phenotypes Suicide MANN, RUJESCU, TURECKI

R01MH082041

288, 289, 290 181

Data received 6/24/2015; need information about suicide behavior and site 289 data

81 Predictors and Mechanisms of Conversion to Psychosis (NAPLS) Schizophrenia ADDINGTON, CORNBLATT

R01MH082004

291, 292, 293, 294, 295, 296, 297, 298 960

08-Mar-2019 BGR: Per Lora & Geetha: We followed up with the NIMH PO on this and explained that we only have the FIGS, information on diagnosis and conversion to psychosis, and demographic information for NAPLS2, but we have had difficulty in obtaining the rest of the clinical information from Dr. Perkins. The Broad has the detailed clinical interview data, but we doubt we?ll be able to get Dr. Perkin?s to provide this. The PO confirmed that we can close out the NAPLS2 study. 11-Feb-2019 BGR - updated fields expected # subjects, samples based on notes below and tara spreadsheet Study Information: For Rutgers Additional Study Information: Study PIs: Addington, Walker, Seidman, Mathalon, Cannon, Cadenhead, Perkins, Woods, Cornblatt Project Number: 5U01MH082004-05 Former Number: 1R01MH082004-01A1 Grant Number: R01MH082004 Start Date: 30-SEP-2008 End Date: 24-SEP-2014 Study Contact: PERKINS, DIANA Contact email: Diana_Perkins@med.unc.edu Distribution: Training Date: 9/20/2017 8 Sites: 291-298 960 Subjects Samples and data released for sharing 12 mos. after receipt; last sample received 7/24/2014; due 7/24/2015 ________________________________________________________________________ Outreach Information: Notes (confirmed contact, status, etc.): 3/16/18: Submitted, In contact ________________________________________________________________________ Phenotypic Data Submission: Submitted as of 3/2018!

82 Expanding Rapid Ascertainment Networks of Schizophrenia Families in Taiwan Schizophrenia TSUANG

R01MH085560

183 9083

diagnosis data received and released, waiting for English version DIGS data to release.

83 Incomplete Response in Late Life Depression: Getting to Remission Depression MULSANT, TSUANG

R01MH083660

277, 278, 279 437

Data received; waiting for processing

84 Predictors of Antidepressant Treatment Response: The Emory CIDAR; Predictors of Treatment Response, Relaps, and Recurrence in Major Depression Depression CRAIGHEAD, MAYBERG

P50MH077083, R01MH080880

276 231

460 inds released in Depression 7.0 on 08-Feb-2018.

85 Language and Risk in Schizophrenia Schizophrenia DELISI

R21MH083205

260 90

Released in SZ Dist. 14.0

86 Autism-Spectrum Disorder Genetics Autism HAINES, PERICAK-VANCE

Autism-Spectrum Disorder Genetics

230 200

05-Mar-2018 BGG: Start dates and end dates estimated based upon grant history in NIMH Reporter. 210 individuals released in AU dist 14 12-Oct-2016

87 Emory-MSSM-GSK-NIMH Collaborative Mood and Anxiety Disorders Initiative Post-traumatic Stress Disorder MAYBERG

U19MH069056

299, 300, 313, 314 108

RFD send;Data requested; Released in PTSD Dist. 1.0 (11/8/2016); will get clinical trial data from NDCT Future Action: clinical trials Data being submitted to NDA-CT therefore Rutgers will process data

88 Depression Susceptibility Genes and Networks: Expression, eQTL and GWAS Analysis Depression LEVINSON

RC2MH089916

621 463

90 A genome-wide association study of Schizophrenia in Ireland Schizophrenia CORVIN, RILEY

R01MH083094

301, 302 562

clinical data will be released June 2017.

91 Whole-genome sequencing for rare highly penetrant gene variants in schizophrenia Schizophrenia GOLDSTEIN

RC2MH089915

258, 259 226

BGR 23-Apr-2019: In RUCDR records, email is listed as d.goldstein@duke.edu

92 Family-Based Genome-Wide Methylation Scan in Neurocognition and Schizophrenia Schizophrenia GUR, NIMGAONKAR

RC2MH089973

320, 321, 322, 323 32

Released in iPSC Dist. 6.0 (1/25/2017)

93 Identifying Intermediate Phenotypes for Compulsive Hoarding Obsessive-Compulsive Disorder MATHEWS

R21MH087748

245 120

94 Common and rare variant genetic screens for clozopine-induced agranulocytosis (CIAC) Schizophrenia SULLIVAN

R01MH080403

324, 325, 326 270

17-Jan-2019 BGR: I am going through and mapping the files per study into the new directory structure for the new website, and part of this process is (quickly) reviewing the submitted phenotypic data to give a short explanation of what the data includes before the user downloads it. I noticed that the data submitted for this study are all about agranulocytosis, and the "short-name" for the study listed on the website is CIAC. I've also been trying to go to SRTP and check that the study names and descriptions are more informative (vs "a study of schizophrenia" for example). In this case, the title did not communicate very well the type of data we have. It also doesn't match the title that WashU had in BioQ or the study description / publication included in the documentation for SZ dist 20.1. The grant number does match the rest of the documentation, I assume because it's a broader grant that a portion of funding was used for this study. I changed the study description to match what is in the documentation posted on the website.

95 Abnormal Sterols in ASD and NIMH HGI Repository Expansion (4000) Autism TIERNEY

RC2MH090027

232, 233, 234 400

2019-05-19, SW: Studysubmission details: Study submitted to the AutoQC. The last submission was on 5/13/19. The only difference should be one added individual. AutoQC ID: 5cd9d27743d85. In the original submission there were 19 IDs not accounted for. In the new submission there are 18. Reason for not including information on those 18 include no records/ineligible. PI gave OK to have these samples destroyed. 11-Feb-2019 BGR - adding 400 subjects/samples expected based on tara spreadsheet and notes contained below. Study Information: This project is a partnership in which the NIMH repository provided sample collection supplies and DNA to a privately funded mental health project in return for the samples and data being distributed through the repository in perpetuity. As such, this project is not subject to NIMH grant terms, but they are subject to the agreement they had in place with the repository prior to submitting any samples. This agreement says we get all the data to go with the samples. NIH funded projects on Autism must put their data in NDAR, but other researchers are also encouraged to do so. *PI DOES NOT EXPECT TO SUBMIT TO NDAR* For Rutgers ________________________________________________________________________ Phenotypic Data Submission: Expected number of subjects: 400 3 sites: 232, 233, 234 PIs: Tierney, Porter, Arnold Study Contact: Dr. Tierney, contact information below Original Due Date: 11/30/2013, now expected 6/2018 Data should have been sent to the repository every 6 months, all data was indicated would be provided for the release. These are the data structure we were told should be coming: The structure and sample size of the study are described below. The number of blood samples proposed to be collected on ASD subjects and their parents and siblings is summarized below. Their cholesterol level status will be known prior to the visit during which the blood will be drawn for the NCGS. No child will have been on a medication that is known to lower cholesterol levels for at least 3 months prior to the blood draw. Hypocholesterolemia is defined as being below the 5th centile of age- and sex-specific mean cholesterol levels of individuals who participated in the CDC?s National Health and Nutrition Examination Survey (NHANES) 2005-2006 study. Hypercholesterolemia is defined as being above the 95th centile. From the age- and sex-specific mean cholesterol values, the standard deviation used to calculate the 5th and 95th centiles was 1.646. 1. Data structure ? Year 1 and 2. A. Interview and collect blood on 150 individuals age 4 ? 12 with autism spectrum disorder [60 with hypocholesterolemia (60 hypo), 60 with normal cholesterol (60 normal), and 30 with hypercholesterolemia (30 hyper)]. B. Collect blood on the biological parents of the 60 ASD subjects with hypocholesterolemia. C. Collect blood on the ASD full-siblings and half-siblings of the 60 ASD subjects with hypocholesterolemia. D. Data structure for the collection of blood from ASD subjects and their parents and siblings: ASD Subjects: 30 hyper, 60 normal, ~60 hypo, 150 total Mother of 60 hypo: 0 hyper, 0 normal, ~60 hypo, ~60 total Father of 60 hypo: 0 hyper, 0 normal, ~60 hypo Siblings of 60 hypo: 0 hyper, 0 normal, ~120 hypo Total number of blood samples: 30 hyper, 60 normal, ~300 hypo, ~390 total (Reported in Data Sharing SS that there are 400 subjects) Environmental indices including social economic status will be evaluated. Parental psychopathology and family dysfunction will not be assessed. 1. Structured diagnostic criteria- Rigorous procedures are in place for characterization and direct assessment of ASD. Psychiatric diagnoses of Autistic Disorder, Asperger?s Disorder, or Pervasive Developmental Disorder-Not Otherwise Specified (PDD-NOS) will be assigned by the clinician after careful review of the results from Autism Diagnostic Interview- Revised (ADI-R), Autism Diagnostic Observation Schedule (ADOS), DSM-IV-TR checklist as well as other study assessments. 2. Comprehensive phenotypic assessment- A medical record review will be performed (when available). A Family and Medical History Questionnaire, which includes questions regarding the gastrointestinal history, the family sleep history, the pregnancy history, and the Rochester Obstetrical Scale. From the child with ASD, we will perform an IQ assessment (Stanford Binet-V, Differential Ability Scale, or Mullen Scales of Early Learning), Autism Diagnostic Interview-Revised (Regular and Current state algorithms), Autism Diagnostic Observation Schedule, Physical exam, Physical parameters (height, weight, temperature, respiratory rate, abdominal circumference, hip circumference, calculation of basal metabolic rate, heart rate, blood pressure, and Occipital-Frontal Circumference if not obtained at Screening Visit); Inner Canthal Distance Measurement; Photos [midfacial and both feet (from above)]; Quality of Life Questionnaire; Ohio Autism Clinical Impression Scale (OACIS)- Severity; Aberrant Behavior Checklist-Community (ABC-C); Speech and Language Testing (via Expressive Vocabulary Test-2 Form A and Peabody Picture Vocabulary Test-4 Form A); the Vineland Adaptive Behavior Scales-II, a 3-day dietary log and the MEDFICTS cholesterol dietary questionnaire will be performed. Direct interviews will be conducted by a well-trained assessment team with established expertise in structured research assessment and application of rating scales for measurement of symptoms and function. We have extensive experience of applying structures assessments, training, and maintaining quality control, including monitoring reliability. ________________________________________________________________________ Outreach Information: As of 2018-07-16, in touch with study. Study actively working on submission. Message sent via help desk to study on this date. -SW

96 Olanzapine Versus Placebo in Outpatients with Anorexia Nervosa Anorexia Nervosa ATTIA, STEINGLASS

R01MH085921

395, 396, 397, 398, 399 160

11-Feb-2019 BGR - added expected # subjects, samples 160 based on notes below and tara spreadsheet. Outreach Information: *TRAINED* As of 5/8/2018: In touch with someone from Dr. Attia?s team, scheduling training 5/1/2018: Called Dr. Attia at (646) 774-5000, left message *Still trying to schedule training!* As of 4/11/2018: Dr. Attia is away, will contact next week to ask about status of submission ________________________________________________________________________ Study Information: For Rutgers Additional information: PIs: Attia, Steinglass, Guarda, Marcus, Kaplan Study Contact: Dr. Attia EMAIL ea12@cumc.columbia.edu PHONE (646) 774-8085 FAX (212) 543-5607 Alternative Contact: Barbara Smolik, 646-774-8084 Sites: 5 (395-399) 160 Subjects Clinical Trial Number: NCT01170117 Data will be deposited within 3 months from end of data preparation There is data on clinicaltrials.gov, but it is not individual level ________________________________________________________________________ Phenotypic Data Submission: The outcome measures were BMI and Obsessions subscale of the Yale-Brown Obsessive Compulsive Scale. Minimum score is 0 and maximum score is 20. Higher scores indicate higher levels of obsessions. Measures were taken pre and post treatment. There were two arms of treatment. We are expecting the submission file, dx file, and the treatment and outcomes measures. The study is complete on clinical trials.gov now and they have published.

97 Studies of Autistic Patients: Gene Networks and Clinical Subtypes Autism RENNERT

Studies of Autistic Patients: Gene Networks and Clinical Subtypes

235 300

For Rutgers

98 The Effects of Estradiol on Genetic Risk for Disordered Eating during Puberty Anorexia Nervosa KLUMP

R01MH092377

246 362

860 inds released in Anorexia dist 2.0

99 Brain-Behavior and Genetic Studies of the 22q11DS 22Q11.2DS GUR

U01MH087626

247, 248 1000

11-Feb-2019 BGR - added expected # subjects 1000 based on tara spreadsheet and notes below. For Rutgers Status as of 3/30/3018 = submitted Additional Information (Data Sharing SS): PIs: Gur, Emanual Contact: Dr. Raquel Gur (raquel@mail.med.upenn.edu) 2 Sites: 247, 248 1,000 Subjects [note to SW- going to another repository? disorder?]

100 A Longitudinal Imaging Study of Infants at Risk for Autism Autism BOTTERON, PIVEN

R01HD055741

236, 237, 238, 239 0

NIH Reporter Project End Date: 31-MAY-2017 from bioq: WashU will complete curation, RU will release. NDAR primary deposit; Data was shared in C0019, C2027 2009-2014.

101 Pharmacogenomics of Mood Stabilizer Response in Bipolar Disorder Bipolar Disorder BERRETTINI, CORYELL, KELSOE, LOHOFF, MCINNIS, NIEVERGELT, NURNBERGER, ODEGAARD

U01MH092758

420, 421, 422, 423, 424, 425, 426, 427, 428, 429 700

11-Feb-2019 BGR - added expected # subjects = 700 based on tara spreadsheet and notes below For Rutgers; https://clinicaltrials.gov/ct2/show/NCT01272531 Additional Information: 10 Sites: 420-429 700 subjects Clinical Trials (as per Data Sharing SS), not going to NDA (there was confusion given Collection Number 2497 at NDA). PIs: Kelsoe, Nievergelt, Calabrese, Nurnberger, McInnis, Gershon, Potash, Zandi, Berrettini, Lohoff, Coryell, Alda, Odegaard Study Contact: Dr. John Kelsoe PHONE (858) 534-5927 FAX (858) 822-1490 EMAIL JKELSOE@UCSD.EDU Subjects will be interviewed using the Diagnostic Interview for Genetic Studies (DIGS4) Collateral information will be obtained from family members and medical records. Diagnoses will be made by review of all information by experienced clinicians using a well established best estimate procedure. Diagnoses will be made using DSM-IV criteria. Verified diagnostic data- Within 12 months of data verification but (best-estimate final diagnoses) no later than 6-30-2015. Would like item level DIGS, they were not specific as to only giving a final diagnosis and we want DIGS data. In addition to the DIGS diagnostic interview, subjects will be extensively assessed during a 2.5 year prospective mood stabilizer trial. Subjects will be stabilized on lithium monotherapy over a 3-4 month period. Those that fail lithium will be crossed-over to valproic acid. Subjects stabilized on mood stabilizer will be followed for two years or until relapse. Survival analysis will be used to detect gene effects on time to relapse. During the stabilization phase, subjects will be assessed approximately every 2 weeks and during maintenance every 2 months. Assessments will include the Quick Inventory of Depression Symptoms, the Hypomania Checklist, the Hamilton Rating Scale for Anxiety, the Montgomery Asberg Depression Rating Scale and the Young Mania Rating Scale. Treatment response data Within 12 months of subject completion and data verification but no later than 6-30-2015 Need at least the ratings, push for as much item level data as possible. GWAS genotypes The genotype data will be made available through dbGAP as soon as appropriate quality control measures are complete and a 12-month period of exclusivity would exist for PI to submit analyses of GWAS datasets for publication. *Need linking IDs to dbGaP*

102 Genomic Studies of Bipolar Disorder in a Large Cohort from the Netherlands Bipolar Disorder OPHOFF

R01MH090553

430, 431 2500

11-Feb-19 BGR - added expected # subjects = 2500 based on tara spreadsheet and notes below. Annabel is working on submission Contact information: a.vreeker@umcutrecht.nl Need _id file for dbGaP For Rutgers PIs: Ophoff, Daalman 2 Sites: 430, 431 2,500 subjects Data Expected: Demographic info - _sub & _dx files Alternate IDs (ie dbGaP, linking samples/pheno data to genetic data)- _id Family history & relevant medical history ? especially drugs/response to treatment in clinical trials. Data Dictionaries for Schedule for Clinical Assessment in Neuropsychiatry (SCAN) and NIMH-Life-Chart Method Interviews (NIMH-LCM-I)- _phen_dd

103 Efficacy and Tolerability of Riluzole in Treatment-Resistant Depression Depression SANACORA, ZARATE

5R01MH085055, 5R01MH085054, 5R01MH085050

622, 623, 624, 625 275

01-MAR-2019 BGR: Deleting site 625 per instruction from Geetha 11-FEB-2019 BGR - Added expected # subjects = 275 based on tara spreadsheet and notes below For Rutgers

104 Comparison of Long-Acting Injectable Medications for Schizophrenia (ACLAIMS) Schizophrenia BYERLEY, CAROFF, JARSKOG, KONICKI, LAMBERTI, STROUP

R01MH081107

327, 328, 329, 330, 331, 332, 333, 334, 335, 336, 337, 338, 339, 340, 341, 342, 343, 344, 345, 346, 347 174

Data received on 5/18/2015 22-Jul-2019 BGR: Added NDA collection number and title

105 Establishing Moderators/Biosignatures of Antidepressant Response- Clinical Care (EMBARC) Depression TRIVEDI

U01MH092221, U01MH092250

626, 627, 628, 629 400

added expected # subjects = 400 based on tara's spreadsheet. multiple samples submitted per subject, as is a timepoint study. For Rutgers

106 Collaborative Genomic Studies of Tourette Disorder Tourette Syndrome HEIMAN, LUDOLPH

R01MH092293

600, 601, 602, 603, 604, 605, 606, 607, 608, 609, 610, 611, 612, 613, 614, 615, 616, 617, 618, 619, 620 2645

Updated data received 9/15/2016; Received some data on 1/29/2015; not ready for distribution BGR 22-Oct-18: According to abstract description in grant, 5050 subjects/samples were expected. Not sure where the 1548 expected # came from. All sites need investigator information to be added.

107 RAISE - Early Treatment Program (ETP) Genetics Schizophrenia KANE

HHSN-271-2009-00019C

350 400

2019-07-16, SW: NDA collection number changed from 2499 to 2249 11-Feb-2019 BGR - Added expected # subjects = 400 based on tara spreadsheet Responsible Party: John Kane, Chairman, Psychiatry, Northwell Health ClinicalTrials.gov Identifier: NCT01321177 Other Study ID Numbers: HHSN271200900019C, HHSN271200900019C

108 Sustaining Remission of Psychotic Depression Depression MEYERS

5U01MH062518, 5U01MH062624, 5U01MH062565, 4U01MH062446

630, 631, 632, 633 177

109 Discovery Science of Human Brain Function Across the Lifespan Brain Function MILHAM

R01MH094639

303 331

Note on sample: Grant ended 2015 with NCE planned enrollment was 1000, but only reached half of that- however the registration occurred in 2012 and they said it would enroll 1000 over 4 years so that would put its end date in 2016 - no record of more to be sent. The PI registered a new project, Study 187, which they were to start sending data on last year. Check that the samples sent last year were not assigned to an incorrect project. Another possibility is that this grant just applied for a renewal (under review) and may have begun collecting again not realizing they had to alert us to expect more samples.

110 D-Cycloserine Augmentation of CBT for Pediatric OCD Obsessive-Compulsive Disorder GELLER, STORCH

R01MH093402, R01MH093381

249, 250 150

Rachel Porth was working on submission, but left her position as of 6/22. Trained Rachel's replacement (Hannah Smilansky) and the individual now responsible for submitting data (Sandra Cepeda) on 6/27. No NDA submission yet due to consent issue (whether or not the consent explicitly asks participants if they allow their information to be shared-- reference email from Sandra on 6/21, consents were determined to be appropriate). It was determined that this study will submit to us and NDA by 7/15/18. -SW ________________________________________________________________________ For Rutgers; https://clinicaltrials.gov/ct2/show/record/NCT01411774 DUNS Number: 073130411 Project Start Date: 1-JUN-2011 Budget Start Date: 1-MAR-2013 CFDA Code: 242 Project End Date: 28-FEB-2015 Budget End Date: 28-FEB-2014 Data Sharing Plan: and 2/2 D-cyloserine Augmentation of CBT for Pediatric OCD, MGH PI: Dr. Daniel A. Geller; USF PI: Dr. Eric Storch Summary: The purpose of the proposed study is to conduct a double-blind, placebo-controlled trial of D-Cycloserine augmentation of cognitive behavior therapy in pediatric patients with obsessive compulsive disorder, in order to determine whether DCS augments the short-term efficacy of CBT to a greater extent than does placebo Another objective is to collect blood samples, create cell lines and extract DNA for future genetic research, including functional gene studies and sequencing, using results from the Genome-Wide Association study (GWAS) of OCD (MGH is coordinating site for GWAS) to examine specific loci in glutamatergic genes. This study is occurring at two sites, MGH, and the University of South Florida. Over the course of four years, each site will recruit 75 participants. If the participant consents to an optional, additional blood draw, this single draw will take place at the screening visit. Subjects unwilling to provide blood may instead give saliva, which will be sent to the NIMH OCD repository at Rutgers where DNA will be extracted and, from blood samples, lymphoblastoid cell lines established. Genotyping is not part of this proposal. Human Subjects Protection: Samples will come from children aged 7-17 who have a primary diagnosis of OCD. At this time no samples have been collected. All samples obtained will be assigned a coded identification number, the key to which will be kept in a separate locked file. No identifying information will be included on the samples. The coded blood or saliva samples will be sent to the National Institute of Mental Health OCD repository at Rutgers University. All personnel working on the genetic component of the project will be blinded to the clinical data collected from the subjects. Biospecimen Collection and Disbursement: We will be submitting blood samples to the NIMH repository, Rutgers Cell and DNA Repository (RUCDR). Participants will be correctly consented by the study P.I., either Dr. Daniel Geller or Dr. Eric Storch, for the donation of biospecimens samples that will result in the creation of lymphoblastoid cell lines and products derived from them (eg. DNA and RNA). Only participant who are correctly consented for the sharing of information and samples will be sent to the NIMH repository (RUCDR). Such samples and information can be distributed to other research projects dependent on NIMH approval. These samples are under the sole governance of NIMH. The consent form for this study is in compliance with the NIMH sample consent form. Samples will be submitted in accordance to standard operating procedures as directed by RUCDR. Upon request, the PI anticipates DNA samples to be returned for future studies. Up to 35ug of DNA from cell lines and 20ug of DNA from saliva may be requested by the investigator(s) at no cost. Genetic Analysis and Data: The reason for collecting genetic blood samples is to create cell lines and extract DNA for future genetic research, including functional gene studies and sequencing, using results from the Genome-Wide Association study (GWAS) of OCD (MGH is coordinating site for GWAS) to examine specific loci in glutamatergic genes. Genotyping is not part of this study?s protocol. Computerized Database: All data related to the identification and blood samples of this study?s participants will be saved on a password protected Excel spreadsheet. The file will be saved on a shared network, behind the Partners firewall. This shared network will only be accessible to study staff and is further protected by a second password. Files on the server are backed up nightly Data Dissemination: Applicant?s organization must comply with the NIH Grants Policy Statement, pages 115-116; ?Sharing of Unique Research Resources? revised December 1, 2003, related to the distribution of unique research resources produced with DHHS funding. Principal Investigator(s) will endeavor to publish all findings in peer-reviewed journals as soon as possible and provide all supporting data to the public domain. Because the community standard for early data release is evolving, grantee?s data sharing may be reassessed at the end of each funding period. The data generated under the ?Genetic Analysis and Data? section will be submitted and released to the public in accordance with the following schedule. Timelines: Resource / Deadlines for Submission / Resource Released: 1. Blood samples / Submitted as collected on continuous basis /6 months after the last sample is received 2. Phenotypic/clinical assessments / Submitted within 6 months of subject blood sample collection and submission / Assessment data released with biospecimens. 3. GWAS data with accompanying study documents, and phenotype data / NA / NA The following clinical measures were in the project: Schedule for Affective Disorders and Schizophrenia for School-Age Children (K-SADS-PL) WASI IQ score CY-BOCS Clinical Global Impression-Severity (CGI-S) Global Impression-Improvement (CGI-I) Children?s Depression Rating Scale-Revised (CDRS) Family Accommodation Scale (FAS) Child Obsessive Compulsive Impact Scale (COIS) Columbia Impairment Scale (CIS/CIS-P) Obsessive-Compulsive Inventory-Child Version (OCI-CV) Multidimensional Anxiety Scale for Children (MASC) Child Behavior Checklist (CBCL) Brief Symptom Inventory (BSI) Client Satisfaction Questionnaire (CSQ-8) Therapist Alliance Scale?Child/Parent Reports (TAS-C/P) CBT Adherence and Competence Homework Compliance Expectancy Rating Questionnaire (ERQ) Hierarchy Progression Index (HPI) Efficacy and safety measures

111 Biomarkers for Psychosis in Velo-cardio-facial Syndrome 22Q11.2DS KATES

R01MH064824

394 64

112 The Genetics of Autism: Epilepsy as a Biomarker Autism DEVINSKY

The Genetics of Autism: Epilepsy as a Biomarker

724, 725, 740 388

414 individuals released in Autism 14.0 on 12-Oct-2016. Project Start date estimate based on first sample received. Project end date estimate based on due date listed in BioQ. study co sent documentation; clarified duplicate named columns; study co Laze sent data; PI Dr. Devinsky declined to use study resources for automated QC system when offered via conference call

113 Identifying Biomarkers for Post-Partum Depression in African-American Women Depression RUBINOW

R01MH095992

634 2000

11-Feb-2019 BGR - added expected # subjects based on tara spreadsheet For Rutgers Update: 4/2/2018: Actively working on submission- SW 8/28/2018: SW called Jerry after 2 email attempts. Asked when to expect submission. Stated by the end of this week.

114 Mapping the Human Connectome: Structure, Function, and Heritability Induced Pluripotent Stem Cells VAN ESSEN

U54MH091657

400 1800

11-Feb-2018 BGR - added expected # subjects based on Tara spreadsheet 5/15/2018: S. Curtis submitted via AutoQC for manual curation Tara 4/5/2018- Added dbGaP and connectomedb information For Rutgers

115 Exploring the Neuronal Phenotype of Autism Spectrum Disorders Using Induced Pluri Induced Pluripotent Stem Cells DOLMETSCH, HALLMAYER

R33MH087898

726, 734 154

11-Feb-2019 BGR - Added expected # subjects based on tara spreadsheet

116 Cellular and genetic correlates of increased head size in autism spectrum disorder Autism VACCARINO

R33MH087879

727 19

11-feb-2019 BGR - added expected # subjects = 40 based on tara spreadsheet

117 Autism iPSCs for Studying Function and Dysfunction in Human Neural Development Autism LORING

R33MH087925

728 4

11-Feb-2019 BGR - added expected # subjects = 8 based on tara spreadsheet

118 Next Generation Gene Discovery in Familial Autism Autism BRKANAC

R01MH092367

729 60

11-Feb-19 BGR - added expected # subjects = 60 based on tara spreadsheet NDAR Collection: 1919

119 Attaining and Maintaining Wellness in OCD Obsessive-Compulsive Disorder SIMPSON

R01MH045436, R01MH045404

401, 402 140

11-Feb-2019 BGR - Added expected # subjects = 140 based on Tara spreadsheet Start/End dates retrieved from RePORT For Rutgers

120 RDoC Constructs: Neural Substrates, Heritability, and Relation to Psychopathology Research Domain Criteria ZALD

R01MH098098

500 396

Released in RDoC Dist 1.0 (820 individuals; 396 GUIDs; 396 RUIDs)

121 Depression (RAPID LFMS) Depression IOSIFESCU, PAPAKOSTAS, SANACORA

HHSN2712011000061

754, 755, 756, 757, 758, 759 90

11-Feb-2019 BGR - added expected # subjects = 90 based on tara spreadsheet For Rutgers 4/2/2018: This study was "affiliated" with Study 149. Clearing up details. -SW ClinicalTrials.gov Identifier: NCT01920555 Study Start Date: December 2014 Primary Completion Date: January 2017 Study Completion Date: February 2017 RePORT Start Date: 10/15/2014 RePORT End Date: 10/14/2015 BioQ End Date: 10/15/2016 ...has same NDA# as Study 149?

122 Characterization of a Mendelian Form of Psychosis in a Population Isolate Schizophrenia ALMASY, GLAHN, RAVENTOS

R56MH097940

319 215

325 inds released in SZ 20.0 on 15-Feb-2018

123 Acute Psychotherapy for Bipolar II Depression Bipolar Disorder SWARTZ

R01MH084831

432 38

124 Multi-pronged genetic studies of schizophrenia in an inbred population Schizophrenia NIMGAONKAR

R01MH093246

349 760

15-Feb-2019 BGR - updated expected # subjects, samples based on notes in biomaterials section. Added study description from grant reporter. For study 124 we expected recruitment of patients with SZ or schizoaffective disorder (SZA, DSM IV criteria, n = 300), control individuals without psychosis matched by age, gender and socio-economic status to the controls (n = 200), first or second degree relatives of the cases (n = 60). All participants were given: the Arabic version of the Arabic version of the Schedule for Clinical Assessment in Neuropsychiatry (SCAN), a structured diagnostic interview schedule. An Arabic version of the Family Interview for Genetic Studies (FIGS) will be completed for each case and control individual. the Arabic version of the Penn Computerized Neurocognitive Battery (CNB) additional Arabic pen and paper questionnaires designed to test intelligence, attention and memory if needed. 3rd RFD email sent 3/7/2017 Updates: 4/2/2018: Actively working on submission

125 Analysis of Glutamatergic Neurons Derived from Patient Specific iPS Cells Induced Pluripotent Stem Cells LACHMAN

R33MH087840

392, 393 13

15-Feb-2019 BGR - updated expected # subjects, samples based on biomaterials notes

126 Autism (ACE Network) Autism CONSTANTINO, GESCHWIND, KLIN, MOLHOLM

R01MH100027

712, 718, 719, 720 1200

15-Feb-2019 BGR - added expected # subjects based on grant description; says 600 probands but does not specify expected # of family members. assumed 1 family member per proband, bringing # of subjects/samples up to 1200 Updates: 4/2/2018: Still waiting to hear about the outcome of extension request

127 Target Identification and Validation for Negative Symptoms and Social Cognition in Schizophrenia: A Translational Study Induced Pluripotent Stem Cells HAHN

funded by Pfizer via University of Pennsylvania ? Pfizer collaborative alliance

717 8

15-Feb-2019 BGR - updated # subjects, samples based on received/released 8 inds released in iPSC dist 9.0 site 717 start and end estimates based on sample receipt dates

128 A Comprehensive Approach To Identification of Autism Susceptibility Genes Autism GESCHWIND, LAJONCHERE

R01MH081754

713, 714, 715, 716 588

15-Feb-2018 BGR - updated expected # subjects based on biomaterial notes "~196 families" assumed family = trio, meaning 588 expected subjects For Rutgers Updates: 4/2/2081: Still waiting to hear about the outcome of requested extension

129 Anorexia Nervosa Genetics Initiative (ANGI Project) Anorexia Nervosa BULIK

Anorexia Nervosa Genetics Initiative (ANGI Project)

403, 404 5900

5-Feb-2019 BGR - updated expected # subjects, samples based on received data submission. No grant to review or notes about original expectations from NIMH. BGR 20-Dec-2018: Notification from Dave Keller about sample/data elimination request for the following subjects: MH0166112, MH0196927, MH0196967, MH0196974, MH0196975, MH0196987, MH0196988, MH0196989, MH0196992, MH0197005, MH0197006, MH0197012. No data has yet been released for this study. Australian site will send samples in 2 batches (at the end of years 2 and 4). Funding from donation. Status = submitted (5a7a136d4494c) ClinicalTrials.gov identifier (NCT number): NCT01916538 Study information taken from CT.gov: Study Type : Observational Actual Enrollment : 22445 participants Observational Model: Case Control Time Perspective: Retrospective Official Title: Anorexia Nervosa Genetics Initiative Study Start Date : June 2013 Primary Completion Date : July 2016 Study Completion Date : July 2016

130 Genomics-Guided Characterization of iPS Cells from Common Mental Illnesses Induced Pluripotent Stem Cells HAGGARTY

R21MH093958, R33MH087896

433, 434 4

15-Feb-2019 BGR - updated expected # subjects based on received and released, no info on sample size in reporter and no origianl expectations recorded from NIMH 4 subjects (13 RUIDs) released in iPSC dist 7.0 on 08-Mar-2017

131 Chemical genomic approaches to neurobiology of DISC1 Bipolar Disorder TSAI

R01MH091115

317, 318 20

15-Feb-2019 BGR - updated expected # subjects/samples based on grant description and received quantities Data released in iPSC collection 2017-06-12

132 NIMH DIRP Protocol 03-M-0035 Screening, Evaluation, Diagnosis, Treatment Optimization and Follow-Up for Childhood Onset Psychiatric Disorders Induced Pluripotent Stem Cells RAPOPORT

1ZIAMH002581

499, 502 228

15-Feb-2019 BGR - Updated expected # samples, subjects based on receipts and release notes 17-Aug-18 BGR: David Panchision confirmed the PI retired and study is complete, listing end date as 31-May-18 as instructed by Linda 05-Mar-2018 BGG: Project start date and end date not listed in Reporter or BioQ. Estimate of 2007 for start date based on history of grant in NIMH reporter. Seems to be renewed every year - unsure of end date, will follow up with Tara. From BioQ: Site 502 data received 1/30/2018, data will be released in iPSC 10 Feb 2018;site 499 Released in iPSC Dist. 3.0; 229 subjects (some with multiple sample IDs) are in iPSC dist 10.0 for this study

133 Biomarker Discovery in Anorexia Nervosa II Anorexia Nervosa BARDONE-CONE, BULIK

R01MH095860

405 420

15-Feb-2019 BGR - updated expected # subjects to match expected # samples that was recorded. not sure if this number should be equal... Funding from a donation. Not yet due (5/31/2018).

134 Genetic Study of Trichotillomania Obsessive-Compulsive Disorder KEUTHEN, SCHARF

Funded by the Trichotillomania Learning Center (TLC).

508, 788, 790 419

Site 788 will be submitting ~100 samples over 3-4 years; Site 790 will submit 22 samples over the course of 1 year Future Action: Given date of Site 788 and 790 expected release date 2020, Rutgers will process data;Site 508 released in Trichotillomania Distribution 1.0 under OCD group; Sites 788 & 790 will be released no later than 6/16/2020

135 Multimodal Developmental Neurogenetics of Females with ASD Autism BOOKHEIMER, PELPHREY

R01MH100028

470, 471, 472, 473 900

Study Information: Four sites: 470, 471, 472, 473 Contacts- Zachary Jacokes (Zachary.Jacokes@loni.usc.edu), Carinna Torgerson (Carinna.Torgerson@loni.usc.edu) ________________________________________________________________________ Outreach Information: 2018-07-18: Emailed to ask how submission was coming along/when the study plans to submit. -SW << Trained 7/3/2018! >> 2018-06-19: Email sent to Zachary Jacokes. -SW 2018-06-19: Second email went out. Received response from Dr. Bookheimer-- OOO until 7/2. Jack Keller gave availability for training, but suggested reaching out to Zachary Jacokes who was responsible for submitting data for the whole project to the NIH biannually. -SW 2018-06-11: First email sent. -SW ________________________________________________________________________ Phenotypic Data Submission: Submitting to NDAR. NDAR study ID is 2021. Asked for _sub, _dx, and _id files. ________________________________________________________________________ Release Information: Will be released 6 mos. after last subject's sample has been received by repository. Project end date = 6/30/2017, last sample = 5/4/2017 ________________________________________________________________________ Updates: 2019-02-18 BGR: Added # subjects = 900 based on notes in biomaterials field 2018-11-19: Dave Keller informed us that the study requested elimination of biomaterials for Subject Code KP.UCL.512.03 / RUID MH0166397. The subject did not request elimination of associated phenotypic, clinical, or imaging data. - BGR 2018-07-18: Study had an issue with IDs. Changes were submitted to RUCDR. Study plans to submit by end of August. SW will follow up with study by middle of August. -SW

136 Integrative Molecular and Phenotype Analysis of 22q11.2 Deletion Syndrome 22Q11.2DS HALLMAYER

R01MH100900

355 60

2019-04-25, SW: Spoke with Sue Cleveland about Ns not matching. Study submitted 61, but RUCDR has 65. After submission 3 were recruited at UCLA and 1 was recruited at Standford. Sue will submit information for those 4. Also, one more subject is coming in 5/31 and 6/1 to have a sample taken-- Sue will submit for that as well. 2019-03-28 SW: Sue Cleveland said that after the grant ended UCLA brought in two more people, and they are looking to enroll one more. The cells did not grow in the lab so they're trying to replace them, which is why they pushed for more participants. She also mentioned that these people should be enrolled, biopsied, and assessments should be scored by next month. Will follow up in a couple of weeks to make sure everything is still going as planned. 2019-02-18 BGR: Updated subjects field to 60 based on notes below and in biomaterials section. more samples expected than subjects 2nd RFD email sent 5/10/2017 NDA RDoC collection #2605. Should this be RDoC or SZ for disorder? Was set on SZ. For study 136, they are characterizing patients with 22q11DS ? 20 with a diagnosis of psychotic disorder and 20 without - and 20 demographically comparable controls, for a total of 60 subjects. As part of the study they completed a questionnaire, underwent a clinical diagnostic interview, underwent neurocognitive testing, and had a skin biopsy. We expected all clinical information to be submitted within 2 months of subject blood and/or or skin sample collection and submission. The clinical interviews included: Structured Interview for Prodromal Syndromes (SIPS) Junior Schizotypy Schedule for dimensional measures of schizotypal traits. K-SADSPL or the Structured Clinical Interview for DSM-IV (SCID-P), for subjects over 18, Brief Psychiatric Rating Scale (BPRS) Autism Diagnostic Observation Schedule (ADOS-G) and the Autism Diagnostic Interview ? Revised (ADI-R) Social Responsiveness Scale (SRS) Cognitive assessments- All study participants receive a comprehensive neurocognitive battery, which includes assessment of intellectual function (Wechsler IQ scales 31), language, memory, executive functions and attention, and social cognition. Other measures height weight head circumference relevant medical and developmental history (not sure what is included here) There should be RNA-seq and micro-RNA seq data that should be going somewhere, either to us or dbGaP, so get the linking IDs if they exist now. They aren?t registered with dbGaP, but the study has not finished yet (project end date 2018/07/31)? so that may be coming. Get as much individual level data as you can, it seems like they collected a lot, though it might not have been collected for all subjects. This is a fibroblast/iPSC study.

137 Genomics of Schizophrenia in the South African Xhosa Schizophrenia STEIN

U01MH096754-01A1

356 2200

Study Information: ~1100 cases, ~1100 controls 2019-02-18 BGR: Populated # subjects field as 2200 based on notes above The main people dealing with the phenotypes are listed below: Howard Andrews- Andrews@nyspi.columbia.edu Ruben Gur- gur@mail.med.upenn.edu Ezra Susser- ess8@cumc.columbia.edu Kim Hendricks- kim.hendricks@uct.ac.za Adele Pretorius- adele.pretorius@uct.ac.za One site: 356 ________________________________________________________________________ Outreach Information: 2018-06-19: Contacted (PI and those listed below) on 5/31/2018. Was told that Howard would be in touch. Waiting for Howard to reach out. -SW ________________________________________________________________________ Phenotypic Data: No cost extension finishes in December. At the moment the project is not submitting anywhere else. In addition to the usual submission data, the project should at least be submitting the computerized neurocognitive battery data and the SCID-I. ________________________________________________________________________ Release Information: Will be released 6 mos. after last subject's sample has been received by repository.* As of 7/18/2018, last sample received was 2/21/2018, but NCE ends 12/2018.

138 Identification of rare variants of OCD Obsessive-Compulsive Disorder NESTADT

R01MH097993-01A1

406 160

Study Information: ~160 blood samples 2019-02-18 BGR: updated subjects field based on note above. this is smaller number compared to what is described in the grant abstract, which also discusses adding 800 unrelated ocd cases and 750 matched controls. One site: 406 ________________________________________________________________________ Outreach Information: 2018-06-19: Contact was made via email on 6/15/18. Dr. Nestadt informed SW about extension. Dr. Nestadt was told on 6/19/18 that an extension does not apply to the phenotypic data, and therefore data is still expected by the end of June 2018. -SW 2018-06-26: Project contacted program about the need for an extension to submit the phenotype data. PO (Miri Gitik) approved an extension until October. PI should submit data by 10/31/2018. - TD(NIMH) ________________________________________________________________________ Phenotypic Data: ________________________________________________________________________ Release Information: Will be released 6 mos. after last subject's sample has been received by repository but no later than 6/30/2018.* Study was granted an extension-- expected to submit data by 10/2018.

139 Addition of OCD to the Genomic Psychiatry Cohort Obsessive-Compulsive Disorder PATO

R01MH103657

407, 417, 783, 787, 805, 822, 881 5000

2019-05-15 BGR: Per Lora Bingamon, Site 881 (The Emory site) is contracted for no more than 300 samples, but actual enrollment may be less than that. Again, this part of the total planned collection for the study. They will be collecting blood and saliva samples through January 31st, 2020. 2019-04-17 BGR: Notification from Dave Keller than RUID MH0244549 requested to be removed from the study with sample and phenotypic data destroyed. Dave Keller has submitted the request for elimination and the RUID will be moved to the elimination file. 2019-03-19 SW: Janet Sobell no longer works on this study. Replaced with Cole Whiteman. 2019-02-18 BGR: added # subjects = 5000 based on grant description and notes below Added site 822 (Menchon); Added site 805 (Richter); Added site 787 (Nicolini); Added site 783 (PI: Nurmi); Added site 417-Dr. Michele Pato moved to SUNY and Dr. Knowles took over the USC site 407 4/23/2018- Tara Dutka New institutional multi-site certificate submitted by SUNY on behalf of all submitting sites. Dr. Pato's contact information updated to SUNY. SUNY is now institute of record for submitting the data for all samples. From BioQ: Will be released 6 mos. after last subject's sample has been received by repository but no later than 2/1/2020 04/22/2019 (LAB): The NIMH PO confirmed that the project will go into a NCE. The project end date is now 01/31/2020. Updated the project ended in SRTP.

140 Genome Sequencing in Extended Bipolar Pedigrees Bipolar Disorder FREIMER

3R01MH095454-02S1

435, 436 349

~1000 BP samples, ~1000 controls 349 subjects released in BP 12.0 on 18-Sep-2017

141 Genetic Analysis of High-Risk Utah Suicide Pedigrees Suicide COON

R01MH099134

315 5100

2019-02-18 BGR: Added # subjects = 5100 based on notes below Study Information: ~5100 DNA samples Study is using postmortem DNA, so they are sending in batches rather than continuously. They had 3,814 suicide cases with DNA samples as of their last progress report and anticipated having 4,500 before they applied for the NCE. Definitely ask about the rest of those cases (8/20/2018, SW) ________________________________________________________________________ Outreach Information: 2018-08-10: SW had training with study. During training it was determined that we should expect a total of 3,821 samples for 5/31/2019 (2,861 we have currently + 480 (5 plates already requested) + 480 (5 more plates to be requested). PI is following up with PO. 2018-07-18: SW reached out to PI again to follow up from last conversation. Explained that data expected to be released no later than 11/30/2018. 2018-07-09: SW emailed to ask if PI returned. PI did not understand what was being requested. SW explained. 2018-06-19: Contact made on 2018-06-16. PI will be OOO until July 9th. Will schedule a time to do a training with her team when she returns (that week). -SW 2018-07-13: Emailed again on 2018-07-09. Asked for a time to train team members. No response as of this date. -SW ________________________________________________________________________ Phenotypic data expectations: Suicide designation from the Utah Office of the Medical Examiner autopsy, gender, age at death, race, method of death, ICD-9 codes approved for this project indicating co-morbid conditions (currently: affective disorders, drug disorders, alcohol disorders, psychoses, self-injury, seizure disorders, inflammatory bowel syndrome, asthma); pedigree cluster ID indicating which pedigree a sample is part of, if any. One site: 315 ________________________________________________________________________ Release Information: Will be released 6 mos. after last subject's sample has been received by repository but no later than 11/30/2018.

142 Psychosis and Affective Research Domains and Intermediate Phenotypes (PARDIP) Research Domain Criteria KESHAVAN, PEARLSON, TAMMINGA

R01MH096913-01A1

496, 497, 498 405

2019-02-18 BGR: Added # of subjects = 405 based on notes below and # samples. sample size not noted in linked grant description 8/8/2018: As of 8/1 submitted. Asked for Acknowledgements and publications. Was told there are no publications at this time. Consent level for study is RELMH at this moment. -SW For Rutgers; ~405 samples; #2126 RDocdb ClinicalTrials.gov Identifier: NCT02218853

143 Modeling Anorexia Nervosa with Human Pluripotent Stem Cells Anorexia Nervosa MUOTRI

R21MH093954-02

408 8

2019-02-18 BGR: Added expected number of subjects and samples based on notes below, not sure if the fibroblasts and iPSCs are coming from the same or a different set of subjects though. 5 fibroblasts lines; 5 dental pulps; 20 iPSC lines

144 Modeling Autism with Human Pluripotent Cells Autism MUOTRI

1DP2OD006495

738 17

2019-03-01 BGR: Deleting site 739 per instruction from Geetha 2019-02-18 BGR: Added expected number of samples and subjects based on notes below. I do not know if the fibroblasts and iPSCs will come from a different set of subjects or overlapping subjects 19 fibroblasts lines; 2 dental pulps; 60 iPSC lines

146 Induced Neuronal Cells: A Novel Approach to Study Neuropsychiatric Diseases Autism WERNIG

R01MH092931

741 12

For Rutgers Not sure how this is connected to autism? Cells will ship ~4/16/2018 and data will be received early May. PHONE 650-721-2495 FAX 650-498-6505 EMAIL wernig@stanford.edu Thomas C. Sudhof PHONE 650-721 1418 FAX 650-498-4585 EMAIL tcs1@stanford.edu The study aims to test the hypothesis that patient fibroblasts can be converted into induced neuronal (iN) cells that can then be used to study cell biological disease phenotypes. We will primarily focus on synaptic transmission as a phenotypic readout. We propose to study about 6 patients affected with autism spectrum disease and respective controls (i.e., about 12 total human subjects to be recruited). Participants in the study will be asked to donate their cells to the NIMH Repository and Genomics Resource (RGR). We have already recruited 7 human subjects and obtained skin fibroblasts from skin punch biopsies (3 patients and 4 controls); 4 biopsies were collected in Boston by a local physician and sent to the Stanford Hospital Cytogenetics lab, Department of Pathology, where the fibroblasts are being derived and banked according to routine clinical practice. Skin biopsies or fibroblast lines: The PI will send source biomaterials including established fibroblast cultures and/or skin biopsies to the Rutgers Cell and DNA Repository (RUCDR) site of the NIMH Repository. Samples will be submitted in accordance to standard operating procedures as directed by RUCDR. The PI will coordinate with the Repository to ensure that cultures derived by the grantee team are expanded in sufficient quantities to ship to the repository. RUCDR personnel will provide procedures and shipping materials including media for submitting the sample and will work with the PI team on any specifically recommended culture conditions. iPSC lines: Note that this project was originally designed to study iN cell reprogramming directly from fibroblasts in the absence of an iPSC derivation step. However, should any iPSC lines be made from a source sample, those will likewise be submitted to the NIMH Repository. In this case, this will include multiple clonal or colony iPSC lines generated from the same subject. (Note: We will not send iN cells since they are postmitotic and thus not a renewable resource. Rather the end-users are expected to follow our protocols to convert fibroblasts into iN cells themselves.) Clinical/Phenotypic Data: We will not obtain a detail clinical assessment. We will rely on the subjects? self reporting of their diagnosis and specific mutation (if known). We will communicate this information to the Washington University site of the NIMH Repository, coincident with the biospecimens deposited at RUCDR under the timeline listed below. No clinical data, just a best estimate diagnosis and demographic data (the standard file and dx file). There should be fibroblast or iPSC derivation data, consult with Mike Sheldon as to what materials are present and discuss with Mike Sheldon and David Panchision whether they have all the data they want so you can make those requests with the phenotype data request.

147 Longitudinal Family/Molecular Genetic Study to Validate Research Domain Criteria Research Domain Criteria FARAONE, GLATT

1R01MH101519-01A1

501 2800

2019-06-20, SW: Updated project end date given confirmation of NCE 2019-02-25 BGR: Dave Keller reported the PI contact as Stephen Glatt (stephen.glatt@psychgenelab.com) in spreadsheet of PI emails for CPL notification. We list Faraone as PI... 2018/11/16: Dave Keller notified us of additional revoked consent for samples MH0177826, MH0177828, MH0179861, MH0180695, MH0180696, MH0181257, MH0181256, MH0181255. No data has been released for these samples. 2018/11/12: Dave Keller notified us of a revoked consent for sample MH0179861 via email on Friday 09-Nov "NIMH Elimination request - MH0179861" -- no data has yet been released for this study. - BGR 2018/08/17: Expected to be complete by the end of September 2018. -SW ~2800 subjects. From bioQ: Will be released 6 mos. after the project end date, 3/31/2019.

148 Identifying regulatory mutations that influence neuropsychiatric disease Schizophrenia GOLDSTEIN, PULVER

U01MH105670-01

357, 358, 359 340

2019-02-25: Dave Keller reported the PI contact as dlevy@mclean.harvard.edu (Deborah Levy), we do not have her listed as a main PI for this study only a site PI. 2019-02-18 BGR: added expected # subjects based on notes below Study Information: ~340 subjects From BioQ: "Due 3 mos. after last subject's sample has been received by repository but no later than 11/30/2018" Sites: 357, 358, 359 ________________________________________________________________________Outreach Information: 2018-07-18: SW emailed PI to ask if her questions were resolved. (Internal note: SW will reach out to other sites-- site 359-- to ask about phenotypic data for submitted samples). 2018-07-10: PI was confused about consents and what can be shared. TD followed up on this. 2018-06-19: Outreach attempts on 5/31 and 6/14. No response. -SW 2018-07-13: Response received on 7/10, PI asked a question related to consent/sharing. Referred to Program. -SW ________________________________________________________________________ Phenotypic Data Submission: Clinical/Phenotypic Data: Phenotype data will be submitted for all biospecimens and data files submitted to RUCDR, dbGaP, or NDAR. Because the phenotypic data will differ between study sites, phenotypic data that will be submitted will at a minimum include sex, age, race, diagnosis, and pedigree information for trios. Additional information may include family history, age of onset, and developmental, social, or learning problems. Diagnosis information ascertained for the Duke cohort include the following classifications: Bipolar Disorder, Schizophrenia/Schizoaffective Disorder, Autism or ASD, Epilepsy/Seizure Disorder, Depression (medicated), ADHD, Mental Retardation/Intellectual Disability, Obsessive Compulsive Disorder, Tourette's Syndrome. ________________________________________________________________________ Release Information: Due 3 mos. after last subject's sample has been received by repository but no later than 11/30/2018.

149 Rapidly-Acting Treatments for Treatment-Resistant Depression (RAPID) Depression CUSIN, FAVA, IOSIFESCU, SANACORA

HHSN271201100006I

760, 761, 762, 763, 764, 765 100

2019-02-18 BGR: Added expected number of subjects based on expected # samples, and enrollment of 99 participants described at clinical trials page referenced below For Rutgers Clinical Trial ID: NCT01920555

150 A study of Schizophrenia Schizophrenia EVANS, FARRELL, JOSIASSEN, SHAUGHNESSY, SULLIVAN

none

354 1000

2019-05-30, SW: Marty Farrell notified the NIMH about sample submission plans over the next few years. It is estimated that over the next 2 years, they will have a total of 30 additional samples for this study. 2019-02-18 BGR: updated expected # subjects to match expected # samples 2017-09-13: increased samples to 1000 and release date to 2019-07-01 Partial phenotype data received from Auto-QC: #58ece32254754 and #58aca0ccb57cc, project ongoing,still submitting samples. Will be released no later to the public than 2019-07-01 Rutgers WILL DO 2019-05-07 LAB: NIMH has agreed take the additional 30 samples the PIs plan to send over the next 2 years. Updated project end date to reflect this change.

151 Predictors and Mechanisms of Conversion to Psychosis Research Domain Criteria ADDINGTON, CANNON, CORNBLATT, MATHALON

2R01MH081902-06A1

486, 487, 488, 489, 490, 491, 492, 493, 494 540

2019-04-22, SW: A note from Jenna Barbee via email: "I anticipate that we will collect between 140 and 215 additional samples at scheduled visits with the NAPLS 3 cohort from now until the end of the study. The latest scheduled blood draw is scheduled to occur in December 2019 or January 2020 (12 months after the last subject was enrolled). This number does not account for samples that were sent to RUCDR between 3/30/2019 and 4/22/2019. Please note that this estimation also does not account for subjects who may convert during this time. If a subject is found to convert, sites are to have them come in for an additional conversion blood draw. My understanding is that we are following subjects past January 2020, so a conversion blood draw could occur later in the year in 2020 (I don?t have as much knowledge about this ? please correct me if I am wrong!). The total number of samples will be less than 3,240 samples. The total number of NAPLS 3 subjects who will have provided samples will be greater than 540. I can provide more specifics if needed. I will review these figures with Diana and we will let you know of any changes she thinks should be made to these estimates." *When asked if would it be OK to say that we expect no more than 2,381 samples (2,166 samples we currently have + 215 additional samples), Jenna stated, "To the best of my knowledge, yes, that would be an accurate estimate of the expected number of scheduled blood draws. I would like Diana to take a look at it to make sure it aligns with her overall expectations. The conversion visit would be considered an unscheduled visit, so any conversion/unscheduled visits that occur could drive that number up. It is likely that Diana may also have an idea of how many unscheduled visits we can expect. I will check with her to see if she can estimate that for you." 2019-04-16, SW: SW in touch with PI. PI stated that study should be finished sending samples by July of 2019. Need Dr. Diana Perkins to confirm this information and the expected number of samples. Waiting for word from Dr. Perkins. SW changed end date from 6/20/2019 to 2/1/2020 on 10/22/18. The data sharing spreadsheet given to our team form TD states Study 151's end date is 2/1/2020. -SW NAPLS3 is multiple R01s. Grants are MH081984; R01MH081944; R01MH081902; R01MH081857; R01MH076989; R01MH081928; R01MH081988; R01MH082022; R01MH082004;They are only collecting 540 subjects, however this is a longitudinal biomarker study with collections at baseline, 2, 4, 6,8, and 12 months. So, the total number of collections expected to be sent are ~ 3240. (8/07/2018, SW) 540 samples From BioQ: Will be released at time of publication or within 3 mos. of the project's end (2/1/2020), whichever comes first. RDoCdb Collection 2275 per JR 04/26/2019 LAB: PO confirmed that the project will go into a 1-year NCE on 07/01/2019. This would make the end date 06/30/2020. Updated SRTP with new project end date.

152 Control and Reward Circuits as Targets for Repetitive Thoughts and Behaviors Obsessive-Compulsive Disorder MARSH

R01MH104648-01

409 80

2019-02-18 BGR: Updated expected # subjects, cases based on notes below Study Information: 40 samples; 40 matched controls; 80 samples total One site: 409 ________________________________________________________________________ Data Expected: Demographic information (age, gender, race-ethnicity), diagnostic data and clinical ratings of OCD and Depression will be provided (i.e., Structured Clinical Interview for the DSM [SCID], Yale Brown Obsessive Compulsive Scales [Y-BOCS], and Hamilton Depression Scale [HAM-D]). ________________________________________________________________________Outreach Information: Submitted: 8/9/2018 (AutoQC#: 5b6c4a3625095) Please note: SW marked study as "trained" on 2018-07-18. Page is submitting for this study and for another study, and she has already been trained on the process. Submission expectations have already been shared with Page. 2018-06-19: In touch with Study. Page VanMeter will be doing the submission. She has been trained for a previous study. On 6/19 details of what is expected were sent to Page, and it was confirmed that it was possible to prove this (above). Page requested data dictionaries. -SW ________________________________________________________________________ Release Information: Will be released 6 mos. after the end of the grant, 2/28/2019

154 FAST MAS KOR Phase 2a Research Domain Criteria LISANBY, NURNBERGER, SANACORA

HHSN2712011000061

410, 411, 412, 413, 414, 415 90

Submitted via AutoQC and NDA files sent separately -- 5b48e084e5dee, N:Brzustowicz LabNRGR_internal_shareSUBMISSIONSstudy154. Hongqiu Yang was contact person. Clinical Trials #: NCT02218736, but also associated with NDA C# 2277 (above) Don't see 2277 in RDoC db, but in Clinical Trials db. Not sure why it was recorded as RDoC for disorder? Do we have the wrong grant number? Recorded as HHSN271201200006I in other places.

155 Gene Networks Influencing Psychotic Dysconnectivity in African Americans Schizophrenia GLAHN

R01MH106324-01

360 750

2019-04-16, SW: SW reached out to study, study is actively recruiting patients and will likely be doing so until at least the end date. Study reported that internal numbers are higher than 467, but this might be due to newest samples not being accounted for (perhaps anything sent in April?). 2019-02-18 BGR: Updated expected # subjects based on grant text and notes below 750 blood samples

156 Transferred from Coriell Collection Bipolar Disorder GERSHON

735, 736 2000

2019-02-25 BGR: Confirmed with Tara we should expect 2000 samples. Confirmed with Dave Keller that we did receive "Yes, I know about these. We do have them in house. I?ll need to get feedback regarding the status of their associated validation, as I believe there were some problems with this aspect at the time of receipt. The other main challenge was not knowing which of the received samples belonged to which collection: bipolar (site 735) or schizophrenia (site 736). There appear to be about 2,014 unique RUIDs associated with this." Linda forwarded some emails from John, Lingwei to Drs DeLisi and Gershon, suggests there is data somewhere on Zork. We need to follow up. ~2,000 individuals; ~500 families

157 Neuroinflammation and Aggression (RDoC) Research Domain Criteria COCCARO

1R01MH104673-01

503 150

2019-02-18 BGR: Updated expected # subjects based on notes below 150 samples 2019-04-22 LAB: NIMH Progam Officer confirmed on 2019-04-11 that Dr. Coccaro's study will go into a NCE. This would make the project end date 2020-07-31. The project end date has been updated in SRTP.

158 Modeling schizophrenia using iPSC neurons Induced Pluripotent Stem Cells BRENNAND

Supported by private funds

361 11

2019-02-19 BGR - updated expected # subjects, samples based on Tara spreadsheet. Used to say expected 50 samples but this is contradicted by notes below and tara spreadsheet from may 2018. 14 iPSC lines 11 inds with 13 RUIDs released in iPSC dist 5.0 start date is a total guess, end date is based on last sample received date

159 A chimeric brain model to study human neurological diseases Autism MUOTRI

1R21MH10777-01

742 6

For Rutgers

160 Contrasting causal microRNAs in forebrain and midbrain COS hiPSC neural cells Induced Pluripotent Stem Cells BRENNAND

5R01MH101454-02

504 11

Study Information: Released in iPSC Dist. 6.0 (1/25/2017) One site: 504; 11 subjects ________________________________________________________________________ Outreach Information: 2018-07-17: Training on 6/25 was not an official training. Need to get demographic information from Study 132. Emailed Study 132 and in touch. On 7/16 asked Study 160 PI to supply IDs used from Study 132. 2018-06-19: Training scheduled for 6/25 at 4:00 pm. -SW ________________________________________________________________________ Phenotypic Data Submission: From DSP: "In order to associate these samples with de-identified fibroblasts and clinical data independently submitted by the Rapoport lab, these particular COS iPSC lines will be labeled with the RUCDR site number followed by the de-identified code (?NSB number?) that the Rapoport lab provided us for each sample. Where more than one iPSC line per patient is submitted, we will place an additional digit/character to the code to distinguish them? We need this code (mentioned above) and demographic information. iPSC study that is using fibroblast from other studies. We expected 2-3 replicate lines/subject for 21 subjects (i.e., 21 subject-lines), so approximately 50 biospecimens total, linked to study 132. Only expecting iPSC data and the data to link these samples back to the original study data (Study 132). Generated these from Fibroblasts they stored on site so linking is the key. *Study 132 has phenotypic data- SW in contact*

161 iPSC-derived human cortical interneurons as developmental model of Schizophrenia Schizophrenia CHUNG

1 R01 MH107884-01

362, 363, 807 6

McLean Hospital will be submitting the samples for Lieber Institute

162 Bipolar-Schizophrenia Network for Intermediate Phenotypes 2 (BSNIP2) Bipolar Disorder TAMMINGA

2R01MH077851-05A1

364, 365, 366, 367, 368 3600

2019-06-26: SW reached out to study regarding submission expectations. SW asked, "I see that we expect 3,600 subjects/samples, and we currently have 899 samples. Do you foresee collecting the full 3,600 samples by your end date? Is there a chance that recruitment or expectations have changed?" Dr. Tamminga replied by stating, "I checked on the plasma samples that I have received and am in the ball park of what you have. We are still collecting. Please keep in touch."

163 Neuropsychiatric Genome-Scale and RDoC Individualized Domains (N-GRID) Induced Pluripotent Stem Cells KOHANE

5P50MH106933

416 134

133 subjects released in iPSC distribution 7.0 2019-02-18 BGR: I have no way of knowing what the expectations for number of subjects and samples were for this study, I only can see what was received and released

164 The Autism Biomarkers Consortium for Clinical Trials (ABC-CT) Autism MCPARTLAND

1U19MH108206-01

474, 475, 476, 477, 478 600

from bioQ: Will be released 3 mos. after the end of the project period, 9/30/2019. NDA C2288. BGR 22-Oct-18 - unclear sample size. Assuming 200 trios are expected, ie 600 samples and subjects, based upon description and received # of samples. 2019-04-22 LAB: The NIMH Program Officer confirmed that Dr. McPartland's study will go into a NCE on 2019-04-11. The project end date is now 2020-06-31. Updated the project end date in SRTP. 2019-04-30 LAB: Added Deliverable 1 (Whole Blood) information provided by the PI data sharing plan.

165 Neural development of human induced pluripotent stem cells from schizophrenia patients Induced Pluripotent Stem Cells SONG

R21/R33MH087874

369 4

2019-02-19 BGR - updated # expected subjects, samples from 13, 13 to 5, 18 based on Tara spreadsheet from May 2018. Fibroblasts and iPSCs (13 samples) 11/12/2018: PI is now at UPenn. shongjun@pennmedicine.upenn.edu is PI email, and Kim is the contact: kchristi@pennmedicine.upenn.edu. -SW Information from the study: 2/22/19: We have data on four lines, but nine samples. The lines that are data are said to be isogenic lines and therefore all of this information is the same. The D2, D3, C1, and C2 descriptors are the Donor IDs and the subsequent numbers are the clonal lines and whether it was gene edited. For example "369-D3-2" is one line from our D3 donor with the DISC1 mutation. "369-D3-2-6R" is a line from the same donor individual in which we rescued the mutation (indicated by "R"). The "M" lines are the control lines in which we introduced the mutation. In other words, D2, D3, C1, and C3 refer to the 4 different donors and the study submitted multiple lines for some of them. Please reference email from Kimberly Christian for further clarification. -SW

166 Juvenile Onset Schizophrenia iPSCs Induced Pluripotent Stem Cells FINDLING, MILLER, TESAR

R21/R33MH087877

370 14

19-Mar-2019 BGR - Moved 2016-02-16 date from released to data due date, we have not yet released this data Not yet trained as of 4/16/18 For Rutgers Robert Miller PHONE 202-994-6988 FAX (216) 368-4650 EMAIL rhm3@gwu.edu Robert Findling PHONE 410.614.3225 EMAIL RFindli1@jhmi.edu Paul Tesar PHONE 216-368-6225 FAX 216-368-0491 EMAIL paul.tesar@case.edu Summary of Project: The goal of our project was to develop a cell-based system whereby neural cells from afflicted individuals could be functionally assayed to interrogate the molecular mechanisms underlying juvenile-onset schizophrenia. Led by Dr. Robert Findling and colleagues, we have collected skin biopsies from 14 juvenile onset schizophrenia patients and controls for induced pluripotent stem cell (iPSC) line generation, which will be submitted immediately. Our clinical colleagues have a recruitment protocol in place for the possibility of acquiring additional biospecimens through March 1, 2017, which would be submitted as a ?second site? ? this will be negotiated with NIMH Program at a later date as an addendum to this Sharing Plan. Established source cell lines for iPSC reprogramming (e.g., fibroblast cell lines): ? Sample type: skin fibroblast cell lines from juvenile onset schizophrenia patients and controls ? Sample number: 14 (8 patients, 6 controls) ? Collection site(s): University Hospitals Case Medical Center, Case Western Reserve University ? Submission start date: 2/1/2016 ? Submission end date: 4/1/2016 ? Submission frequency: 1-2 submissions ? Disposition: each fibroblast line will be sent in 1-2 cryovial(s) using shipping kits provided or recommended by RUCDR. PI is not requesting any cells in kind. Immediate Reprogrammed cell lines (e.g., iPSCs, iNSC, iGPC, iOPC): ? Sample type: iPSC ? Sample number: 5 patients + 4 controls x 1 replicate lines/subject = 9 total iPSC lines ? Reprogramming site(s): Case Western Reserve University ? QC data: each iPSC line will be sent in 1-2 cryovial(s) using shipping kits provided or recommended by RUCDR. PI is not requesting any cells in kind. The iPSC lines will be accompanied by relevant culture information to inform the use of cells (e.g., reprogramming factors, vectors, media, passage number); this will be entered into a form supplied by RUCDR. ? Submission start date: 2/1/2016 ? Submission end date: 4/1/2016 ? Submission frequency: 1-2 submissions Immediate Clinical assessments and Phenotypic data (specify types): ? Data type: Demographic information (gender, ethnicity, age at time of assessment), relevant medical history such as medications at time of biopsy, and CGS score. ? Submission start date: 2/1/2016 ? Submission end date: 4/1/2016 ? Submission frequency: Single submission Released with associated biospecimens. Sequence data (e.g., DNA sequence alignments to a reference sequence or de novo assembly, RNA: ? Data type: Genotyping ? Sample number: 9 SNP (5 cases, 4 controls); 9 exome (5 cases, 4 controls) ? Platform: Illumina Omni5 SNP, Illumin Exome ? Performance site(s): Case Western ? File formats: processed genotypes, fastq ? Submission start date: 2/1/2016 ? Submission end date: 2/1/2017 ? Submission frequency: After data cleaning and quality control, data will be submitted at 6 month intervals. Released according to NIMH Genomic Data Sharing Policy. This is an iPSC study. They should have submitted the clinical assessments listed (Demographic information (gender, ethnicity, age at time of assessment), relevant medical history such as medications at time of biopsy, and CGS score) and a best estimate diagnosis. So that is the two standard submission files. They have genotype and exome data which should have gone to dbGaP. If it did, we need the accession number and linking IDs, if it hasn't been submitted to dbGaP yet they are out of compliance with GDS, so we need to know that too. Consult with Mike Sheldon as to what materials are present and discuss with Mike Sheldon and David Panchision whether they have all the data they want so you can make those requests with the phenotype data request.

167 Biomarker Assessment of Pomaglumetad on Glutamate Targets: Proof of Clinical Mechanism of Action (POCM) Controls LIEBERMAN

HHSN271201200007I, HHSN27100003

793, 794, 795, 796 81

As of 8/8/2018, submitted to NDA. Submitted via AutoQC on 5/22/18. -SW Schizophrenia study, but clinical trials involving controls.

168 Mapping the Human Connectome During Typical Aging Brain Function BOOKHEIMER, SALAT, TERPSTRA, VAN ESSEN

U01 AG052564

797, 798, 799, 800 1500

2018/11/12: RUCDR was notified in September of one subject (798-HCA9985722) who was ineligible for the study and requested the sample (MH0221868) be destroyed. No data has been released for this study as yet. - BGR 2018/11/12: Adding notes for previous revoked consent (March 2017) for subject 798-HCA6880490. Subject 798-HCA8257784 was ineligible for the study, so samples were requested to be destroyed (Aug 2017). Again, no data has yet been released for this study. - BGR

169 Genomics of Postpartum Depression. Depression MELTZER-BRODY, SULLIVAN

There is no grant number for this study

669, 769 25000

2019-02-19 BGR - updated expected # of subjects to 25,000 (was 0) based on Tara spreadsheet from may 2018.

170 Cognitive-Affective Psychosis Proneness Risk and protective factors in 22q11.2DS 22Q11.2DS SIMON

1R01MH107108-1

770 150

2019-03-08 BGR - expected # = 150, but none received according to RUCDR reports. Project start date says 2015, end date 2020?withdrawn? Lump sum submission at the end of the project? Geetha/Lora feedback: Not sure about this. ACTION? Geetha will need to follow up with the Program Officer on this to get clarification. They have been enrolling subjects, but they never sent samples. They say they will send 150 samples of blood. Again, we will follow up with the PO for this grant to confirm. 03/01/2019 update: Geetha reached out to the Program Officer to clarification on the cumulative number of samples for the project that is expected. Will provide further update once PO responds. 03/05/2019 update: The PO?s understanding is the PI had agreed to send the samples periodically but that the Repository would not release the samples until 12 months after the grant period. She was not aware whether any samples were ever sent. She provided e-mails the PI had with NIMH and the Repository. The Repository should have sent EDTA tubes according to the e-mail correspondence.

171 Genetic Contributions of Negative Valence Systems to Internalizing Pathways Research Domain Criteria ROBERSON-NAY

R01MH101518

771 800

Renamed Study 176 to 171 to fix numbering error 2016-04-08. As of 4/2/2018, in contact, waiting on submission...

172 A Clinical Study to Establish a Metabolic Biomarker-Based Test to Diagnose Autism Spectrum Disorder in Early Childhood Autism BURRIER

1R44MH107124-01

772, 773, 774, 775, 776, 777, 784, 786 1500

Study Information: Eight sites: 772, 773, 774, 775, 776, 777, 784, 786 (as reported on sharing ss) ________________________________________________________________________ Outreach Information: 2018-07-13: Study trained as of 7/3. Study stated that due date (to us) is 9/30/2018. 2018-06-19: Lindsay Feuling is out due to injury. Will reschedule training when recovered. ________________________________________________________________________ Phenotypic Data Submission: Specifics on phenotypic and demographic information, diagnostic criteria, primary and secondary diagnosis, medical history, family information); Inclusion criteria for the ASD subjects in this study will include a diagnosis of autism by DSM-IV or V criteria, which will be confirmed by the Autism Diagnostic Observation Schedule (ADOS) and/or Autism Diagnostic Interview-Research (ADI-R) tools, administered by an ASD specialist. We will target a male to female ratio of subjects in the autism group that reflects that of the ASD population (approximately 4:1). TD subjects will be recruited from area school districts and community centers. The Mullens Scales of Early Learning (MSEL) will be used as a screening tool to ensure the absence of symptoms of ASD in the TD control children. Study confirmed during training that _phen and _phen_dd files will be needed for the following: ADOS SCQ MSEL Fam/med history Phys./neuro. exams Additional forms (not known by study during training) ________________________________________________________________________ Data Sharing Details: Study plans to submit by 9/30/2018. -SW Phenotypic data should be submitted within 6 months of biospeciman submissio, to be completed by the project year 3 end date of 3/31/3018. Clinical data is released with associated biospecimens, but not later than 3 months after the project ends assuming the grant is funded for 3 years. Estimated 6/30/2018 (data sharing ss). ________________________________________________________________________ Release Information: Will be released to the public no later than 1/31/2019.

173 Collaboration on preclinical autism cellular assays, biosignatures, and network analyses (Copacabana) Autism YEO

1U19MH107367-01

778 1

2019-04-09, SW: As per conversation with NIMH program staff on 2019-04-08, changed end date (from 2019-08-31) in SRTP to match end date on grant (2020-06-30). Study is trained, will reach out again ~January 2020 to receive an update on submission efforts.

174 The Role of Dysmyelination in Cognitive Impairment of Psychotic Disorders Schizophrenia LAZAR

1R01MH108962-01

779 210

22-Jul-2019 BGR: added NDA collection number and title

175 Neurobiology of Autism With Macrocephaly Autism VACCARINO

R01MH109648

780 72

2019-02-18 BGR: Added expected # subjects = 72 based on aim 1 and aim 2 descriptions in genetic data notes sections below

176 iPSC phenotype, mitochondrial haplotype and psychosis in 22q11 deletion syndrome Schizophrenia ANDERSON

1R01MH110185-01

771, 781 1

2019-02-18 BGR - added expected # subjects = 3 based on notes below. unclear why cases and controls are marked as expecting 300 each, when notes below mention only 9 expected samples (3 allele combo per 3 subject lines)...? // 2019-02-19 BGR - updated # subjects to 1 based on Tara spreadsheet

177 Mitochondrial Dysfunction in Schizophrenia. Induced Pluripotent Stem Cells VAWTER

MH085801-06

782 0

178 Human Connectome Project for Early Psychosis. Brain Function BREIER, SHENTON

U01MH109977

791, 792 400

320 cases, 80 controls 2019-04-16, SW: SW in touch with Study PI. PI stated that the study has been extended to 9/30/2020 (SW did not yet confirm this with PO), and will likely recruit up to the very end of the study. Study plans to submit 400 samples.

179 Ultra High Field Strength MRI and MRS Study of Bipolar Disorder in Adolescents Bipolar Disorder BLUMBERG

R21MH108940

789 52

Study Information: One site: 789 ________________________________________________________________________Outreach Information: 2018-07-18: SW in touch with study. Clarifying confusion about study end date. 2018-06-19: PI out of country until July.Will schedule training upon return. ________________________________________________________________________ Phenotypic Data Submission: Demographic information (gender, ethnicity, age at time of assessment), results of diagnostic assessment (KSADS/SCID), family psychiatric history, relevant medical history. ________________________________________________________________________ Data Sharing Details: Released with associated biospecimens, within 3 months after last clinical dataset is received but no later than project end date (12/31/2018) or the time of publication, whichever occurs first.

180 Mapping the Human Connectome During Typical Development Brain Function BARCH, BOOKHEIMER, SOMERVILLE, THOMAS, VAN ESSEN

U01MH109589

801, 802, 803, 804 1500

2018/11/12: RUCDR was provided a list of inds by Cynthia Hodge on 14-May-2018 to destroy samples from studies 180 and 168 -- Data for this study has not yet been released. Per CH "*The majority of these samples were never sent to RUCDR and were destroyed on site prior to shipping, once exclusion/withdrawal happened. BUT, in some cases, consent was later withdrawn or the participant was later withdrawn from the study by the investigator. Therefore, please check samples against this complete list and discard any sent to RUCDR. For questions, contact Cynthia Hodge hernkec@wust.edu" - BGR

181 Development of New therapeutic targets for patients with Bipolar disorder who are resistant to conventional psychotropic medications using induced Pluripotent Stem Cells (iPSC) Bipolar Disorder CHUNG, GAGE

There is no grant number associated with this study

806 20

182 Systematic Functional Interpretation of Regulatory Variants in Schizophrenia Induced Pluripotent Stem Cells DUAN, PENZES

R01MH106575; R21MH102685

808, 809, 836 20

12-Mar-2019 BGR: Moved date from "Release Date" to "Data Due Date" field -- release date is meant to be filled in when the data has been released. Site 808-material derived from Study 6 and site 809-materials derived from Study 29

183 Multimodal analysis of high-risk psychosis mutations in induced neuronal cells Induced Pluripotent Stem Cells LEVINSON, SUDHOF, WERNIG

U19MH104172

810, 811 20

Site 810-modified cell lines from Study 29 and site 811-modified cell lines from Study 6

184 iPSC-based platform development for major psychiatric disorder modeling and discovery Bipolar Disorder ALDA, BANG, CHEN, GAGE, MCINNIS, OSHEA, SONG

U19MH106434

812, 813 0

2018-02-18 BGR: Moved release date here, expected release date: 2021-11-30. I do not know how to enter expected # of subjects, it is confusing with the different sample type descriptions.

185 Alzheimer?s Disease Connectome Project Alzheimer's Disease BENDLIN, LI

UF1AG051216

814, 815 300

2019-02-18 BGR: Updated expected samples based on biomaterial notes below, "A total of approximately 600 samples, 150 x 2 each collected at Medical College of Wisconsin & University of Wisconsin ? Madison." Interpreting to mean 2 samples per subject.

186 Dissecting functional roles of schizophrenia risk gene ZNF804a in neural development Induced Pluripotent Stem Cells MAO

R21MH108983

816, 817 3

2019-02-18 BGR: Updated expected number of subjects = 3 based on biomaterials notes below "? Sample number: 3 allele combinations x 3 clonal lines/subject = 9 clonal lines" Study Information: New submission date will be 12-30-2019. Please reference help desk ticket #307. Two sites: 816, 817 Site 816-modified cell lines from Study 125 and site 817-modified cell lines from Study 132 ________________________________________________________________________ Outreach Information: 2018-07-17: PI received extension. New submission date is 12/30/2019. 2018-06-19: PI is requesting extension. ________________________________________________________________________Phenotypic Data Submission: N/A (as per data sharing SS)

187 Healthy Brain Network Brain Function MILHAM

Not associated with an active grant

818 6500

188 Aging and Emotion Regulation Brain Circuitry in Bipolar Disorder Bipolar Disorder BLUMBERG

R01MH113230

819 160

189 Genetics of Severe Mental Illness -Colombia Schizophrenia BEARDEN, FREIMER, LOPEZ-JARAMILLO

R01MH113078

820 10000

BGR 20-Dec-2018: DK informed of request to destroy 2 samples due to sample swap (MH0240696, MH0240697). No data has yet been released for this study.

190 MicroRNA Dysregulation in Pyschiatric Disorders and Cognitive Dysfunction. Induced Pluripotent Stem Cells GOGOS, MARKX

R01MH097879

821 12

191 Longitudinal Assessment of Posttraumatic Syndromes. Post-traumatic Stress Disorder JOVANOVIC, KESSLER, KOENEN, MCLEAN, PALLIN, PEARSON, RESSLER, SERGOT

U01MH110925

823, 824, 825, 826, 827, 828, 829, 830, 831, 832, 833, 841, 842, 843, 846, 847, 865, 866, 867, 872, 873, 874, 875, 876, 877, 878, 879, 880 10400

192 Modeling the Human Neuronal Phenotype of the Schizophrenia-Associated 3q29 Deletion Induced Pluripotent Stem Cells MULLE

R01MH110701

834 90

193 Binge Eating Genetics INitiative (BEGIN) Anorexia Nervosa BULIK

na

835 5000

194 Dimensional Connectomics of Anxious Misery Fear & Anxiety SHELINE

U01MH109991

837 250

2019-05-07, SW: New email: Sheline@pennmedicine.upenn.edu (changed from sheline@mail.med.upenn.edu)

195 Large-scale reprogramming and expression analysis of patient-derived neural cells in schizophrenia Induced Pluripotent Stem Cells BRENNAND, BUXBAUM

R01MH111679

838 111

196 Recruitment and Characterization of Healthy Research Volunteers for NIMH Intramural Studies. Controls CHUNG

n/a (Protocol number 17-M-0181)

839 2000

197 A conserved transcriptional cascade involved in brain overgrowth, social behavior and autism. Autism WYNSHAW-BORIS

R01MH113106

840 12

198 Clinical, Laboratory and Biomedical Characterization of Acute-onset Neuropsychiatric Syndrome (PANS) Anorexia Nervosa SWEDO

848, 849, 850, 851, 852, 853, 855, 856 6400

Tara Dutka 3/27/2018 This study may require its own distribution for PANS/PANDAS as well as the ones marked. Eating Disorder generally would also be more appropriate than AN. Below is the total expect subject number. Project has agreed to two releases - one at 1/1/2023 and one at 1/1/2028. Exact content of releases negotiable but should include all collected samples with basic phenotype data. in discussion to get more data. Project will also be submitting to NIH Clinical Trials Data Base ( will need to add this option to other databases) Total Number of Subjects: 6,400 Cases: 1,600 Controls: 1,600 Psychiatric disorders contrast group: 800 Healthy Pediatric Volunteers: 800 First degree relatives (of PANS Probands): 3,200

199 The GEN-SCRIP Study (GENetics of SChizophRenia in Pakistan) Schizophrenia KNOWLES

R01MH112904

854 17000

12-Mar-2019 BGR: Moved date from "Release Date" to "Data Due Date" field -- release date is meant to be filled in when the data has been released. Tara 4/19/2018 Registration Notes: This study has 3 institutes involved, but is only collecting samples in Lahore. Samples will be shipped in batches. Saqib Bajwa is the lead Co-I responsible for the recruitment in Lahore. The contact for the shipping is below: Lahore Contact Person: Arsalan Hassan Lecturer Department of Pharmacy Road 2, University of Peshawar, Peshawar KPK, Pakistan Zip code 25120 arsalan@uop.edu.pk Cell : +923463100484 Tel: +92919216750 Lahore Shipping Address: 551, Airline Housing Society Near University of Central Punjab Lahore, Pakistan The target release date for this project is November 1, 2022 (6 months after the project end date)

200 Mechanisms of Circuit Failure and Treatments in Patient-derived Neurons in Autism Autism MORROW

R01MH105442

857 20

Tara 5/22/2018 - This is an iPSC study that should have been registered several years ago. Sample number: Approximately 20 subject lines (10 proband-control pairs) x 3-5 clonal lines/subject = 60 to 100 clonal lines

201 Cellular, molecular, and functional imaging approaches to understanding early neurodevelopment in autism. Project 3: Biological substrates of risk and resilience using patient-derived stem cells Autism VACCARINO

P50MH115716

858 48

12-Mar-2019 BGR: Moved "Release Date" to "Data Due Date." Release date is meant to record when data is actually released. Tara 5/ 23/2018 48 subjects- 192 samples (Blood, Fibroblast, iPSC[2 lines]) - Samples and data to be released beginning 6/1/2019 until end of study

202 Genetic Characterization of Neurodevelopmental Disorders in African Populations (NeuroDev Africa) Brain Function ABUBAKAR, DONALD, ROBINSON

859, 860 3000

12-Mar-2019 BGR: Moved date from "Release Date" to "Data Due Date" field -- release date is meant to be filled in when the data has been released. Sample update 8/7/2018: expected number of samples is listed as 3,000 in the SRTP. That would correspond to the 3,000 S. Africa subjects, but the project also expects to collect 2,600 subjects in Kenya, with NRGR to extract DNA. The Kenya arm of this project is still under negotiations. They plan to be submitting a separate data sharing plan for Kenya and want to make that a separate study when it negotiations are completed, as it may be conducted differently and have a slightly different timeline depending on the resources in Kenya (i.e. batched frozen samples instead of continuous and no cell lines). That new study will reflect the 2,600 in Kenya. Tara 5/24/2018 The project anticipates 100 trios and 700 single mothers. Samples for CPL production will only be collected from a subset of subjects (0-1200). LCL/iPSC production is not currently funded. For the release: After a two-year period described below, sample and data sharing will be allowed to the fullest extent permitted under applicable laws and regulations. All de-identified research samples and data (both genomic and phenotypic) that are produced based on any samples Broad receives from the NeuroDev South Africa site will be shared broadly through multiple routes, including: ? Controlled access databases such as dbGaP, MatchMaker Exchange, NRGR and/or NIMH Data Archives, etc. ? Controlled access consortia databases such as Psychiatric Genomic Consortium, Autism Spectrum Consortium etc. ? Open access data bases such as The Genome Aggregation Database (GnomAD), The Atlas of Human Malformation Syndromes in Diverse Populations, ClinVar etc. Data and samples will be shared on the first occasion of either A or B as follows: ? At the end of a two-year period, as follows: one year after the data freeze we will make the samples and data public; after an additional one year publication embargo, external investigators may publish on those samples or data. The date of the data freeze will be defined by the NeuroDev principal investigators. This sharing plan is consistent with that supported by NHGRI, the African Society for Human Genetics, and the Wellcome Trust for the H3 Africa initiative. OR ? At the time of publication of the first consortium-level (pooled data across sites) manuscript using the data from that freeze.

203 Collaborative Genomic Studies of Tourette Disorder: Phase II Tourette Syndrome BROWN, COFFEY, GILBERT, HEIMAN, HUYSER, KUPERMAN, WILLSEY, ZINNER

R01MH115958; R01MH115959; R01MH115960; R01MH115961; R01MH115962; R01MH115963; R01MH115993

600, 601, 602, 603, 604, 606, 608, 610, 611, 612, 614, 615, 616, 620, 861, 862, 863, 864, 890 3000

Tara Dutka 6/20/2018 24 is the expected total number of sites. The majority of the foreign sites are pending IRB approval. We have reserved site numbers for them and will register these sites as they are approved. 4 samples are expected per subject with a total of 3000 subjects.

204 Autism Genetics, Phase II: Increasing Representation of Human Diversity Autism GESCHWIND

R01MH100027-11

712, 718, 719, 720 1906

21-May-2019 BGR: Updated number of samples from 5718 to 1906 based on description below from Tara -- multiple tube types per subject need not be counted separately as distinct samples. Received this instruction from Linda. 7/23/2018- Tara Dutka Registration Notes Project is a renewal of prior ACE project (Study 126) dbGaP deposit will go through NDAR Project is recruiting ~1906 Subjects (3 samples sent to NRGR,1 sample retained for samples) 1 whole blood (purple top) for wbDNA isolation 2 whole blood (yellow top) for LCL generation by NRGR 1 whole blood for RNA isolation (retained at UCLA) * For patients who cannot tolerate a blood draw: one saliva sample (retained by UCLA) in lieu of any whole blood samples. In our experience, up to ~3% our cohort may require a saliva sample. The minimum participating unit is a duo (proband & one biological parent). However, we encourage participation from both parents and any full- or half-siblings. Though the family compositions and exact number of participants cannot be known at this time, we estimate that ~35% of ASD probands will have two biological parents participating; ~30% will have an unaffected sibling; and some families will have more than one child with ASD.

205 Hoarding disorder in older adults: cognition, etiology and functional impact. Obsessive-Compulsive Disorder MACKIN, MATHEWS

R01MH117114

870, 871 3500

21-May-2019 BGR - Changed number of samples from 7000 to 3500 based on deliverable descriptions below, 1500 saliva and 2000 whole blood expected. Linda instructed to fix this listing. 8/24/2018 -Tara Dutka Placed temporarily in OCD collection. Subjects are GRU consent. May want to change to create hoarding disorder collection. Target release for samples and all data is 6 months after last sample is received (approximately 2/2024).

209 Stanford Technology Analytics and Genomics in Sleep (STAGES) Study Research Domain Criteria MIGNOT

3249

882 27000

2019-05-28 (LAB): This study is supported by The Klarman Family Foundation.

Study Title Distributions PIs Grants Sites Subjects GWAS Notes