Bipolar Disorder · Observational Study

Evaluation of the Genetics of Bipolar Disorder

ClinicalTrials.gov · September 10, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a completed observational registry study of genetic factors in bipolar disorder, led by NIMH, with 4210 enrolled participants. No results are reported in this registry record. The study is registered as observational with outcomes defined as clinical diagnosis by interview; findings remain unpublished here.

What was studied

Observational. Bipolar Disorder; age from 18 Years; to 100 Years. Intervention: Healthy Volunteers; Patients. n = 4,210. 1 site: United States.

Key findings

Safety

Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

This is a completed observational genetics registry study with no reported results in this record; it describes enrollment and planned outcome measures only, making it preliminary evidence pending publication of findings.

Study design

As stated by the source record.

MethodsFamily Based model. Cross Sectional time perspective. Primary outcome measure: Diagnosis of bipolar disorder or related mental illness by direct interview (assessed at Diagnosis is established primarily at the initial study visit. Participants who…)

DesignObservational

PopulationBipolar Disorder; age from 18 Years; to 100 Years

Sample size4,210

InterventionHealthy Volunteers; Patients

Setting1 site: United States

Reported figures

Quoted from the source exactly as published.

Sample size4210

Study typeObservational

Primary outcome measureDiagnosis of bipolar disorder or related mental illness by direct interview

Recruitment statusCompleted

Caveats

No results or outcome data reported in this registry record.
Study design, methods, inclusion/exclusion criteria, and follow-up duration not described.
Geographic location and number of sites not specified.
No effect sizes, confidence intervals, or statistical significance reported.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

Observational design; no randomization, blinding, or comparator arm.

Directness

limited

Genetic association study; outcome is diagnosis by interview, not mechanistic or molecular evidence.

Consistency

insufficient

No results reported in registry record; consistency cannot be assessed.

Risk of bias

insufficient

Registry record does not report conduct details, blinding, or dropout rates.

Sample adequacy

strong

4210 participants enrolled; large sample for genetic association study.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT00001174). This is a study registration, not published results. Lead sponsor: National Institute of Mental Health (NIMH). Recruitment status: COMPLETED. Study type: OBSERVATIONAL. Enrollment: 4210 participants (ACTUAL). Conditions: Bipolar Disorder. Primary outcome measures: 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.. Brief summary: This study looks to identify genes that may affect a person's chances of developing bipolar disorder (BP) and related conditions.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

Bipolar DisorderNational Institute of Mental Health (NIMH)NCT00001174