Omega-3 Fatty Acids in the Treatment of Bipolar Disorder: A Double-Blind, Placebo-Controlled Trial
Status:
Completed
Trial end date:
2002-08-01
Target enrollment:
Participant gender:
Summary
This study will examine the effectiveness of omega-3 fatty acids, compounds found in plants
and fish, in treating bipolar disorder.
Some studies have indicated that omega-3 fatty acids may be effective in treating mood
disorders.
For example, one investigator has shown a correlation between the prevalence of major
depression and the amount of fish consumed per capita worldwide. Others have found decreased
amounts of EPA (one of the active ingredients in omega-3 fatty acids) in the red blood cells
of patients with major depression. And a recent small study of patients with bipolar illness
indicated that omega-3 fatty acids prevented relapses, especially of depression, in patients.
Patients with bipolar disorder who are not benefiting satisfactorily on their current
medications are eligible to participate in this study. Candidates will be screened with a
psychiatric evaluation, routine blood tests, a urine test and other tests needed to monitor
medications. Participants will be randomly assigned to one of two groups: one group will
receive 6 grams of omega-3 fatty acid every day for 16 weeks; the second will receive a
placebo (inactive capsule). In addition, patients in both groups will continue to take their
previous medications. Every 2 weeks, all patients will have their vital signs checked and be
evaluated for side effects and mood changes. At the end of the 16-week study period, all
patients will be given the opportunity to continue in the study for another 8 months and
receive active drug (omega-3 fatty acid). Patients who continue will be evaluated once a
month and will have blood drawn on the last visit for routine tests.