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Evaluation of the Genetics of Bipolar Disorder

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ClinicalTrials.gov Identifier: NCT00001174
Recruitment Status : Recruiting
First Posted : November 4, 1999
Last Update Posted : September 16, 2021
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) )

Tracking Information
First Submitted Date November 3, 1999
First Posted Date November 4, 1999
Last Update Posted Date September 16, 2021
Actual Study Start Date August 11, 1994
Primary Completion Date Not Provided
Current Primary Outcome Measures
 (submitted: December 3, 2019)
To ascertain individuals with bipolar disorder and at least one affected relative and to conduct direct diagnostic interviews and collect blood samples for testing, lymphoblastoid cell lines and/or extraction of DNA. [ Time Frame: ongoing ]
To ascertain individuals with bipolar disorder and at least one affected relative and to conduct direct diagnostic interviews and collect blood samples for testing, lymphoblastoid cell lines and/or extraction of DNA.
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Evaluation of the Genetics of Bipolar Disorder
Official Title Bipolar Genetics: A Collaborative Study
Brief Summary This study looks to identify genes that may affect a person's chances of developing bipolar disorder (BP) and related conditions....
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 Type Observational
Study Design Observational Model: Family-Based
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population community samples and clinical samples
Condition Bipolar Disorder
Intervention Not Provided
Study Groups/Cohorts
  • Healthy Volunteers
    Healthy volunteers
  • Patients
    Patients with bipolar disorder
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: August 5, 2006)
4000
Original Enrollment
 (submitted: June 23, 2005)
3350
Study Completion Date Not Provided
Primary Completion Date Not Provided
Eligibility Criteria
  • 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.

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Emily Besancon (866) 644-4363 emily.besancon@nih.gov
Contact: Francis J McMahon, M.D. (301) 451-4455 mcmahonf@mail.nih.gov
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00001174
Other Study ID Numbers 800083
80-M-0083
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) )
Study Sponsor National Institute of Mental Health (NIMH)
Collaborators Not Provided
Investigators
Principal Investigator: Francis J McMahon, M.D. National Institute of Mental Health (NIMH)
PRS Account National Institutes of Health Clinical Center (CC)
Verification Date April 20, 2021