Bipolar Disorder Clinical Trial
Official title:
Omega-3 Fatty Acids in the Treatment of Major Depression and Bipolar Disorder: A Double-Blind, Placebo-Controlled Trial
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.
Status | Completed |
Enrollment | 240 |
Est. completion date | August 2002 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
Patients must meet DSM-IV criteria for Bipolar Disorder, depressed, hypomanic/manic, or
rapid-cycling type. Patients must be competent to comprehend the purpose of the study and provide informed consent. Patients must be at least 18 years old. Patients enrolling in the bipolar depression component of the study must have a depression of sufficient severity to rate greater than or equal to 16 on the Inventory of Depressive Symptomatology-Clinician (IDS-C), or the clinician must decide there is a need to treat. Patients enrolling in the bipolar hypomania/mania component of the study must have a hypomania/mania of sufficient severity to rate greater than or equal to 12 on the Young Mania Rating Scale or the clinician must decide that there is a need to treat. Patients enrolling in the bipolar rapid cycling component of the study must have mood fluctuations meeting one or both of the above acute episode criteria in the past 3 months or show a pattern of ultra rapid cycling (4 or more episodes within a month) or ultradian cycling (cycling within a day on 4 or more days/week) on the NIMH-LCM. Patients must not have a serious medical illness. Patients must not have non-insulin dependent diabetes mellitus (NIDDM) or insulin-dependent diabetes mellitus (IDDM). Patients must not have acute suicidal or homicidal ideation. |
Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | National Institute of Mental Health (NIMH) | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Institute of Mental Health (NIMH) |
United States,
Edwards R, Peet M, Shay J, Horrobin D. Omega-3 polyunsaturated fatty acid levels in the diet and in red blood cell membranes of depressed patients. J Affect Disord. 1998 Mar;48(2-3):149-55. — View Citation
Hibbeln JR. Fish consumption and major depression. Lancet. 1998 Apr 18;351(9110):1213. — View Citation
Maes M, Smith R, Christophe A, Cosyns P, Desnyder R, Meltzer H. Fatty acid composition in major depression: decreased omega 3 fractions in cholesteryl esters and increased C20: 4 omega 6/C20:5 omega 3 ratio in cholesteryl esters and phospholipids. J Affect Disord. 1996 Apr 26;38(1):35-46. — View Citation
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