Omega-3 Fatty Acids in the Treatment of Bipolar Disorder: A Double-Blind, Placebo-Controlled Trial

Launched by NATIONAL INSTITUTE OF MENTAL HEALTH (NIMH) · Nov 3, 1999

Keywords

ClinConnect Summary

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, polyunsaturated fatty acids found in plant and marine sources. There are preliminary data to suggest that omega-3 fatty acids may be efficacious in the treatment of mood disorders. Patients in our bipolar outpatient clinic will be at one of the five NIMH - Stanley Foundation Bipolar Network (the "Network") sites participating in this project. Subjects will be randomly assigned in a double-blind ...

Gender

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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.