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.
Phase:
Phase 2
Details
Lead Sponsor:
National Center for Complementary and Integrative Health (NCCIH)