Evaluation of the Genetics of Bipolar Disorder

Sponsor
National Institute of Mental Health (NIMH) (NIH)
Overall Status
Recruiting
CT.gov ID
NCT00001174
Collaborator
(none)
6,000
1

Study Details

Study Description

Brief Summary

This study looks to identify genes that may affect a person's chances of developing bipolar disorder (BP) and related conditions....

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Bipolar affective disorder is a severe, heritable condition affecting about one percent of

    the population. The mode of inheritance is poorly understood and probably involves multiple loci of small to moderate effect. In this project, we use genetic mapping and sequencing methods to identify genetic markers and variations that contribute to the risk of bipolar disorder. Individuals diagnosed with bipolar disorder are studied, along with their relatives. Phenotypic information obtained from clinical interviews and family history is correlated with genotypic information obtained from genetic marker and sequencing methods. The goal is to identify genes involved in bipolar disorder and related conditions so that better methods of diagnosis, treatment, and prevention can be developed.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    6000 participants
    Observational Model:
    Family-Based
    Time Perspective:
    Cross-Sectional
    Official Title:
    Bipolar Genetics: A Collaborative Study
    Actual Study Start Date :
    Aug 11, 1994

    Arms and Interventions

    Arm Intervention/Treatment
    Healthy Volunteers

    Healthy volunteers

    Patients

    Patients with bipolar disorder

    Outcome Measures

    Primary Outcome Measures

    1. Diagnosis of bipolar disorder or related mental illness by direct interview [Diagnosis is established primarily at the initial study visit. Participants who consent to recontact are re-evaluated when they or family informants report events that could lead to a revised diagnosis.]

      Psychiatric diagnosis is based on systematic review of established signs and symptoms, using an instrument designed to elicit retrospective information of known reliability, supplemented with information from family informants, any medical records, and by dimensional symptom measures.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    • INCLUSION CRITERIA:

    Age > 18 yr

    Able to provide informed consent

    Bipolar disorder or related conditions not attributable to substance abuse, neurological disease; or a 1st or 2nd degree relative of an enrolled participant. Related conditions are defined as those found more often among relatives of people with bipolar disorder or which have been shown to be genetically correlated with bipolar disorder through molecular genetic studies. These include major depression, schizophrenia, panic disorder, and attention deficit hyperactivity disorder.

    Able to safely provide a blood or saliva sample

    EXCLUSION CRITERIA:

    Active alcohol or substance abuse.

    NIMH employees/staff and their immediate family members will be excluded from the study per NIMH policy.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National Institutes of Health Clinical Center Bethesda Maryland United States 20892

    Sponsors and Collaborators

    • National Institute of Mental Health (NIMH)

    Investigators

    • Principal Investigator: Francis J McMahon, M.D., National Institute of Mental Health (NIMH)

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    National Institute of Mental Health (NIMH)
    ClinicalTrials.gov Identifier:
    NCT00001174
    Other Study ID Numbers:
    • 800083
    • 80-M-0083
    First Posted:
    Nov 4, 1999
    Last Update Posted:
    Aug 25, 2022
    Last Verified:
    May 9, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by National Institute of Mental Health (NIMH)
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 25, 2022