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Genetic Markers and Variations in Bipolar Disorder

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
Study AimThis study aims to observe genetic markers and variations in individuals diagnosed with bipolar disorder or related mental illnesses.
What is being collected

Data Collection

Collected at a single point in time - Cross-sectional
Who is being recruted

Bipolar Disorder

From 18 to 100 Years
+7 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Family-Based

Studying health outcomes within families in order to identify genetic or familial contributions to disease.
Observational
Study Start: August 1994

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Summary

Principal SponsorNational Institute of Mental Health (NIMH)
Study ContactEmily K Besancon
Last updated: August 14, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: August 11, 1994Actual date on which the first participant was enrolled.

This study aims to uncover genetic factors that contribute to bipolar disorder, a serious mental health condition that affects about 1% of people. Researchers are using advanced techniques like genetic mapping and whole exome sequencing to study individuals with bipolar disorder and their relatives. By identifying specific genes linked to the disorder, the study hopes to improve diagnosis, treatment, and prevention strategies. Understanding these genetic influences could provide a clearer picture of how the disorder develops and responds to treatment, offering new avenues for managing the condition. Participants in the study will have their genetic information analyzed through SNP arrays and whole-exome sequencing. Their mental health history, including symptoms and responses to treatments like lithium, will be gathered through interviews and questionnaires. Some participants may also provide skin or blood samples for further analysis. The study evaluates the genetic data alongside mental health assessments to identify patterns and subgroups within families that could reveal new insights into bipolar disorder. The information collected is securely stored in a national database for future research, and some cells may be used to create stem cells for additional studies. This research has the potential to significantly advance understanding and care for those affected by bipolar disorder.

Official TitleBipolar Genetics: A Collaborative Study 
Principal SponsorNational Institute of Mental Health (NIMH)
Study ContactEmily K Besancon
Last updated: August 14, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
6000 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Family-Based
These studies involve members of the same family to explore how genetics and shared environments may contribute to a disease. They help researchers pinpoint inherited risk factors.

How participants are selected
Participants are selected without using randomization. They may be chosen based on convenience, access, or willingness to participate. This approach is common when random selection isn’t practical.
Another way to select participants is through a probability sample, where participants are chosen randomly, so everyone has an equal chance to be included.

How information is collected
Researchers collect data at a single point in time, offering a snapshot of health, exposures, or conditions in a specific population. These studies are useful for understanding current patterns and prevalence.Other Ways to Collect Data
Prospective: These studies collect new data moving forward over time.
Retrospective: These studies use existing medical records or past data.
Others: Some studies use a mix of approaches or less common designs depending on the research goal.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 18 to 100 YearsRange of ages for which participants are eligible to join.
Healthy volunteers allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Bipolar Disorder
Criteria
5 inclusion criteria required to participate
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.
Ability to safely provide a blood or saliva sample.
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.

Show More Criteria

2 exclusion criteria prevent from participating
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.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
2 intervention groups 

are designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Healthy volunteers
Group II
Patients with bipolar disorder
Study Objectives
Primary Objectives

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.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
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National Institutes of Health Clinical CenterBethesda, United StatesSee the location
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One Study Center