Omega-3 Fatty Acids in the Treatment of Major Depression and Bipolar Disorder: A Double-Blind, Placebo-Controlled Trial
Ethyl Eicosapentaenoic Acid
+ OmegaBrite
Bipolar and Related Disorders+3
+ Mental Disorders
+ Depressive Disorder
Treatment Study
Summary
Study start date: October 1, 1999
Actual date on which the first participant was enrolled.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 manner to 6 grams per day of omega-3 fatty acids or placebo (paraffin capsules) as an "add-on" to ongoing treatment with mood stabilizing medication(s) which have proven unsatisfactorily effective within therapeutic range(s) or at maximum tolerated dose(s). The double-blind trial will continue for 4 months duration. Patients will then be offered the option of entering an eight month, open-label trial of omega-3 fatty acid. The hypothesis of this study is that omega-3 polyunsaturated fatty acids in the form of eicosapentaenoic acid (EPA) acting on some of the same signal transduction mechanisms as the mood stabilizers will be beneficial in breakthrough depression, mania and cycling of bipolar disorder.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.240 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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.
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
National Institute of Mental Health (NIMH)
Bethesda, United StatesOpen National Institute of Mental Health (NIMH) in Google Maps