Omega-3 Fatty Acids in Bipolar Disorder

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

n/a

Study Design

Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Bipolar Disorder

Clinical Trial Details

NCT number	NCT00010868
Study type	Interventional
Source	National Center for Complementary and Integrative Health (NCCIH)
Contact
Status	Completed
Phase	Phase 2
Start date	July 2000
Completion date	July 2004

View Details

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