Omega-3 Fatty Acids in the Treatment of Bipolar Disorder: A Double-Blind, Placebo-Controlled Trial
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|ClinicalTrials.gov Identifier: NCT00001146|
Recruitment Status : Completed
First Posted : November 4, 1999
Last Update Posted : March 4, 2008
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.
|Condition or disease||Intervention/treatment||Phase|
|Bipolar Disorder Involutional Depression Mood Disorder||Drug: Ethyl Eicosapentaenoic Acid Drug: OmegaBrite||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||240 participants|
|Official Title:||Omega-3 Fatty Acids in the Treatment of Major Depression and Bipolar Disorder: A Double-Blind, Placebo-Controlled Trial|
|Study Start Date :||October 1999|
|Estimated Study Completion Date :||August 2002|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00001146
|United States, Maryland|
|National Institute of Mental Health (NIMH)|
|Bethesda, Maryland, United States, 20892|