NCT00001486

Brief Summary

This large ongoing study at NIMH investigates the neurobiology of schizophrenia by identifying susceptibility genes, evaluating their impact on brain function to better understand how to treat and prevent this illness....

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,914

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 15, 1995

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

November 3, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 4, 1999

Completed
Last Updated

May 7, 2026

Status Verified

January 14, 2026

First QC Date

November 3, 1999

Last Update Submit

May 6, 2026

Conditions

Schizoaffective DisorderSchizophrenia

Keywords

Negative SymptomsBrain ScansHallucinationsDelusionsPsychosis and SchizophreniaNatural History

Outcome Measures

Primary Outcomes (1)

  • Genetic Polymorphisms affect phenotypes

    genotyping analysis

    At time of study participation

Secondary Outcomes (1)

  • PANSS, AIMS, GAF

    At time of study participation

Study Arms (4)

Normal Controls

Male and female adult healthy volunteers

Parents

Parents of Probands and siblings for the purposes of DNA collection

Probands

Adult Subjects with Schizophrenia Spectrum Disorders

Siblings

Adult siblings of Probands

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Probands, healthy controls, siblings, parents

You may not qualify if:

  • Probands must have a DSM IV-R diagnosis of schizophrenia,schizoaffective disorder, psychosis N.O.S. or schizophreniform disorder.
  • Probands and Siblings must be between the ages of 18 and 55
  • Probands and Siblings must be free of major medical illnesses, but may have controlled hypertension, thyroid disease, or diabetes.
  • Probands and Siblings must have the cognitive ability to consent for themselves. Those who are judged to have the cognitive ability to consent for themselves at the time of participation, but do not have the legal capacity to consent for themselves may participate if the legal guardian /Legal authorized representative (LAR) provides consent by signing the informed consent form.
  • Fluency in English is required.
  • Seizure disorder, mental retardation, organic brain damage or other neurological disease.
  • History of any (excepting nicotine-related) DSM5-defined moderate to severe substance use disorder (or DSM-IV-defined substance dependence).
  • Cumulative lifetime history of any (excepting nicotine-related) DSM5-defined mild substance use disorder (or any DSM-IV-defined substance abuse), either in excess of 5 years total or not in remission for at least 6 months.
  • Head trauma with loss of consciousness over 5 minutes from all but genetic sampling.
  • Chemotherapy.
  • NIMH employees/staff and their immediate family members will be excluded from the study per NIMH policy
  • Siblings who do not qualify for the 2-day or 1-day study, may participate in the limited phenotyping arm in which only a psychiatric interview and a blood draw for genetic analysis (SCID-DNA) will be performed, case control analysis or be included as part of a trio (one parent, one sibling, one patient) to study genetic transmission from parents to offsprings.. All parents are eligible for the study.
  • To be eligible for this research study, healthy volunteers must be:
  • Between the ages of 18 and 55
  • Fluency in English is required
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Publications (8)

  • Cloninger CR. Genetic principles and methods in high-risk studies of schizophrenia. Schizophr Bull. 1987;13(3):515-23. doi: 10.1093/schbul/13.3.515.

    PMID: 3306908BACKGROUND

  • Cornblatt BA, Keilp JG. Impaired attention, genetics, and the pathophysiology of schizophrenia. Schizophr Bull. 1994;20(1):31-46. doi: 10.1093/schbul/20.1.31.

    PMID: 8197420BACKGROUND

  • Holzman PS, Kringlen E, Levy DL, Haberman SJ. Deviant eye tracking in twins discordant for psychosis. A replication. Arch Gen Psychiatry. 1980 Jun;37(6):627-31. doi: 10.1001/archpsyc.1980.01780190025002.

    PMID: 7190001BACKGROUND

  • Kippenhan JS, Gregory MD, Nash T, Kohn P, Mervis CB, Eisenberg DP, Garvey MH, Roe K, Morris CA, Kolachana B, Pani AM, Sorcher L, Berman KF. Dorsal visual stream and LIMK1: hemideletion, haplotype, and enduring effects in children with Williams syndrome. J Neurodev Disord. 2023 Aug 26;15(1):29. doi: 10.1186/s11689-023-09493-x.

    PMID: 37633900DERIVED

  • Page SC, Sripathy SR, Farinelli F, Ye Z, Wang Y, Hiler DJ, Pattie EA, Nguyen CV, Tippani M, Moses RL, Chen HY, Tran MN, Eagles NJ, Stolz JM, Catallini JL 2nd, Soudry OR, Dickinson D, Berman KF, Apud JA, Weinberger DR, Martinowich K, Jaffe AE, Straub RE, Maher BJ. Electrophysiological measures from human iPSC-derived neurons are associated with schizophrenia clinical status and predict individual cognitive performance. Proc Natl Acad Sci U S A. 2022 Jan 18;119(3):e2109395119. doi: 10.1073/pnas.2109395119.

    PMID: 35017298DERIVED

  • Ursini G, Punzi G, Langworthy BW, Chen Q, Xia K, Cornea EA, Goldman BD, Styner MA, Knickmeyer RC, Gilmore JH, Weinberger DR. Placental genomic risk scores and early neurodevelopmental outcomes. Proc Natl Acad Sci U S A. 2021 Feb 16;118(7):e2019789118. doi: 10.1073/pnas.2019789118.

    PMID: 33558239DERIVED

  • Toulopoulou T, Zhang X, Cherny S, Dickinson D, Berman KF, Straub RE, Sham P, Weinberger DR. Polygenic risk score increases schizophrenia liability through cognition-relevant pathways. Brain. 2019 Feb 1;142(2):471-485. doi: 10.1093/brain/awy279.

    PMID: 30535067DERIVED

  • Marenco S, Meyer C, van der Veen JW, Zhang Y, Kelly R, Shen J, Weinberger DR, Dickinson D, Berman KF. Role of gamma-amino-butyric acid in the dorsal anterior cingulate in age-associated changes in cognition. Neuropsychopharmacology. 2018 Oct;43(11):2285-2291. doi: 10.1038/s41386-018-0134-5. Epub 2018 Jul 3.

    PMID: 30050047DERIVED

Related Links

MeSH Terms

Conditions

Psychotic DisordersSchizophreniaHallucinationsDelusions

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersPerceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsBehavioral SymptomsBehavior

Study Officials

  • Karen F Berman, M.D.

    National Institute of Mental Health (NIMH)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
OTHER
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 1999

First Posted

November 4, 1999

Study Start

July 15, 1995

Last Updated

May 7, 2026

Record last verified: 2026-01-14

Data Sharing

IPD Sharing
Will not share

Locations

US(1)