Active — Not RecruitingNot Applicable

Evaluation of the Genetics of Bipolar Disorder

United States4,185 participantsStarted 1994-08-11

Plain-language summary

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

Who can participate

Age range

18 Years – 100 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Stated willingness to comply with all study procedures and availability for the duration of the study.
. Male or female, aged 18 years and over. Children are excluded for the following reasons: age at onset of BD is usually later than age 18, the diagnostic and assessment instruments we use are not validated in children.
. In good general health as evidenced by medical history or diagnosed with or exhibiting symptoms of bipolar disorder or related conditions not attributable to substance abuse, or 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.
. Ability to safely provide a blood or saliva sample.
. Ability of subject to understand and willingness to sign a written informed consent document.

Exclusion criteria

. Active alcohol or substance abuse.
. Subjects who suffer cognitive impairment and are unable to provide an accurate psychiatric history are excluded since much of the diagnostic information relies on selfreport and recall of past events.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This study is focused on genetics and diagnosis through interviews rather than testing a new treatment — does that mean it wouldn't change my current care plan, and is that the right fit for where I am in my diagnosis journey?
2Since this trial is 'active not recruiting,' is there any chance my doctor knows of a similar genetics study on bipolar disorder that is currently enrolling, or a related study I might be eligible for?
3The study measures diagnosis of bipolar disorder through direct interview — could participating in that kind of structured diagnostic process actually give me or my care team more useful clinical information about my condition?
4Because this is a genetics study with no listed phase, there's no experimental treatment involved — but are there any privacy or insurance-related risks I should be aware of before sharing my genetic and psychiatric information with a research study?
5If a close family member also has bipolar disorder or related mental illness, would it be worth asking whether family-based genetic research like this could still benefit future patients, even if we can't enroll right now?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Diagnosis of bipolar disorder or related mental illness by direct interview

Timeframe: 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.

Trial details

NCT IDNCT00001174

SponsorNational Institute of Mental Health (NIMH)

Sponsor typeNIH

Study typeOBSERVATIONAL

View on ClinicalTrials.gov More Bipolar Disorder trials