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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00517036 |
This study will test the effectiveness of two different kinds of omega-3 fatty acid dietary supplements in treating the symptoms of major depression.
Condition | Intervention | Phase |
---|---|---|
Depression |
Dietary Supplement: EPA omega-3 fatty acid Dietary Supplement: DHA omega-3 fatty acid Dietary Supplement: Placebo comparator |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Omega-3 Fatty Acids for Treatment of Major Depression: Differential Effects of EPA and DHA, and Associated Biochemical and Immune Parameters |
Estimated Enrollment: | 300 |
Study Start Date: | July 2006 |
Estimated Study Completion Date: | July 2011 |
Estimated Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A: Experimental
Participants will take EPA
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Dietary Supplement: EPA omega-3 fatty acid
1 gram per day of an EPA-enriched mixture for 8 weeks
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B: Experimental
Participants will take DHA
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Dietary Supplement: DHA omega-3 fatty acid
1 gram per day of pure DHA for 8 weeks
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C: Placebo Comparator
Participants will take placebo
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Dietary Supplement: Placebo comparator
1 gram per day of an inactive substance for 8 weeks
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Major depression is a common mental disorder that affects millions of people each year. It can severely impact a person's life, causing someone to often feel sad and hopeless, as well as affect a person's sleep patterns, concentration, and energy levels. Despite the availability of numerous therapies, current treatments are not ideal for some people. Recently, some research has shown that an increase in dietary intake of polyunsaturated fatty acids (PUFAs), such as omega-3 fatty acid, might help treat depression. Eicosapentanoic acid (EPA) and docosahexanoic acid (DHA) are two common types of PUFAs high in omega-3 fatty acids and are available in low dosages in some dietary supplements. The purpose of this study is to compare the effectiveness of an EPA-enriched mixture versus pure DHA versus a placebo in treating the symptoms of major depression.
Participants in this double blind study will be randomly assigned to one of three study groups. Participants assigned to the first study group will receive capsules containing 500 mg of an EPA-enriched omega-3 fatty acid preparation. Participants assigned to the second study group will receive capsules containing 500 mg of pure DHA. Participants assigned to the third study group will receive capsules containing a placebo. The study will last approximately 9 weeks. This will include an initial screening the first week followed by an 8-week period during which all participants will take two capsules of their assigned treatment each morning. Participants will attend a total of six study visits. The initial visit will last approximately 2 hours and will include a psychiatric assessment, urine and blood collection, an electrocardiogram (EKG), and a Food Processor Questionnaire. Participants who qualify for further participation will then enter a 1-week washout period during which they will stop taking any current psychotropic medication. At the second study visit, participants will be assigned to their treatment group. Upon starting assigned treatments, participants will then return for study visits every 2 weeks to report any possible side effects and to complete standard psychiatric assessment tests. All of these study visits will take approximately 1 hour, except the last, which will take 2 hours. In addition to the psychiatric assessment and review of side effects, the final study visit will also include a physical exam and blood collection.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Lindsay Crist, M.A. | 310-423-7978 | Lindsay.Crist@cshs.org |
United States, California | |
Cedars Sinai | Recruiting |
Los Angeles, California, United States, 90048 |
Principal Investigator: | Mark H. Rapaport, MD | Cedars-Sinai Medical Center |
Principal Investigator: | David Mischoulon, MD, PhD | Massachusetts General Hospital |
Responsible Party: | Cedars-Sinai Medical Center ( Mark H. Rapaport, MD/Chairman ) |
Study ID Numbers: | R01 MH73765, DATR A5-ETMA |
Study First Received: | August 14, 2007 |
Last Updated: | September 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00517036 |
Health Authority: | United States: Federal Government |
major depression omega-3 major depressive disorder |
Depression Mental Disorders Mood Disorders |
Depressive Disorder, Major Depressive Disorder Behavioral Symptoms |