Omega-3 Fatty Acids in Bipolar Disorder

ClinicalTrials.gov ID: NCT00010868

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Official title

Omega-3 Fatty Acids in Bipolar Disorder Prophylaxis

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This is a 12 month study of omega-3 fatty acids in bipolar disorder. This study will be a 12-month, parallel group, double-blind comparison of the prophylactic efficacy of omega-3 fatty acids vs. placebo in 120 bipolar I patients. All subjects entering the primary prophylactic study will be euthymic or have only subsyndromal mood symptoms for at least 4 weeks. In addition, their concomitant medication (only lithium, divalproex, or no medication will be permitted) will also be stable and at accepted therapeutic levels for at least 4 weeks. An 8-week lead-in phase will be available to subjects who do not meet the current symptom and concomitant medication inclusion criteria (however, subjects must meet all of the other inclusion/exclusion criteria): 1. 4 weeks of euthymic or subsyndromal mood. 2. Subjects who are not already receiving lithium or divalproex. 3. Subjects receiving other psychotropic medications.

Study identification

NCT ID: NCT00010868
Recruitment status: Completed
Study type: Interventional
Phase: Phase 2
Lead sponsor: National Center for Complementary and Integrative Health (NCCIH); NIH
Enrollment: Not listed

Conditions and interventions

Conditions

Bipolar Disorder

Interventions

Omega-3 Fatty Acids Drug

Drug

Eligibility (public fields only)

Age range: 18 Years to 65 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Jul 2000 (Type not available)
Primary completion: Not listed
Completion: Jul 2004 (Type not available)
Last update posted: Aug 18, 2006

2000 – 2004

United States locations

U.S. sites: 2
U.S. states: 2
U.S. cities: 2

Facility	City	State	ZIP	Site status
McLean Hospital	Belmont	Massachusetts	02478	—
Baylor College of Medicine	Houston	Texas	77030	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT00010868, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Aug 18, 2006 · Synced Nov 14, 2026