Omega-3 Fatty Acids for Treating Adults With Major Depression
| Tracking Information | |||||||||
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| First Received Date ICMJE | August 14, 2007 | ||||||||
| Last Updated Date | April 2, 2013 | ||||||||
| Start Date ICMJE | July 2006 | ||||||||
| Primary Completion Date | January 2011 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Depression rating scale score on HAM-D 17, SCID Mood Module [ Time Frame: Both measured at Week 8 ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||||||
| Change History | Complete list of historical versions of study NCT00517036 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE |
Depression rating scale score [ Time Frame: Measured at Week 8 ] | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Omega-3 Fatty Acids for Treating Adults With Major Depression | ||||||||
| Official Title ICMJE | Omega-3 Fatty Acids for Treatment of Major Depression: Differential Effects of EPA and DHA, and Associated Biochemical and Immune Parameters | ||||||||
| Brief Summary | This study will test the effectiveness of two different kinds of omega-3 fatty acid dietary supplements in treating the symptoms of major depression. |
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| Detailed Description | 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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 3 | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
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| Condition ICMJE | Depression | ||||||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 196 | ||||||||
| Completion Date | January 2011 | ||||||||
| Primary Completion Date | January 2011 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 80 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00517036 | ||||||||
| Other Study ID Numbers ICMJE | R01 MH073765, R01MH073765, DATR A5-ETMA | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Mark Rapaport, Emory University | ||||||||
| Study Sponsor ICMJE | Cedars-Sinai Medical Center | ||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | Cedars-Sinai Medical Center | ||||||||
| Verification Date | April 2013 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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