Status:
COMPLETED
Omega-3 Fatty Acids in the Treatment of Bipolar Disorder: A Double-Blind, Placebo-Controlled Trial
Lead Sponsor:
National Institute of Mental Health (NIMH)
Conditions:
Bipolar Disorder
Involutional Depression
Eligibility:
All Genders
Phase:
PHASE2
Brief 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 effecti...
Detailed Description
The aim of this study is to examine the efficacy of omega-3 fatty acids in the form of eicosapentaenoic ethyl esters (EPA) - in the treatment of bipolar disorder. Omega-3 fatty acids are long-chain, p...
Eligibility Criteria
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.
Key Trial Info
Start Date :
October 1 1999
Trial Type :
INTERVENTIONAL
End Date :
August 1 2002
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT00001146
Start Date
October 1 1999
End Date
August 1 2002
Last Update
March 4 2008
Active Locations (1)
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1
National Institute of Mental Health (NIMH)
Bethesda, Maryland, United States, 20892