Evaluation of the Genetics of Bipolar Disorder

Bipolar Disorder Clinical Trial

Official title:

Bipolar Genetics: A Collaborative Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00001174
• Other study ID #: 800083
• Secondary ID: 80-M-0083
• Status: Recruiting
• Start date: August 11, 1994

Study information

• Verified date: August 16, 2023
• Source: National Institutes of Health Clinical Center (CC)
• Contact: Emily Besancon
• Phone: (866) 644-4363
• Email: emily.besancon[@]nih.gov
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6000
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

• 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.

Related Conditions & MeSH terms

• Bipolar Disorder

Locations

Country	Name	City	State
United States	National Institutes of Health Clinical Center	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnosis of bipolar disorder or related mental illness by direct interview	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.	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.

External Links

•   NIH Clinical Center Detailed Web Page