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Fish Oil for the Treatment of Depression in Patients With Multiple Sclerosis
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| Tracking Information | ||||
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| First Received Date ICMJE | July 20, 2005 | |||
| Last Updated Date | May 11, 2017 | |||
| Start Date ICMJE | July 2005 | |||
| Primary Completion Date | June 2009 (Final data collection date for primary outcome measure) | |||
| Current Primary Outcome Measures ICMJE |
Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: baseline to 3 months ] Higher MADRS scores indicate more severe depression, and the overall score ranges from 0-60. A score of 0-6 indicates symptoms absent, 7-19 indicates mild depression, 20-34 moderate, and > 34 severe. Our primary outcome was 50% or greater improvement on the Montgomery-Asberg Depression Rating Scale (MADRS). |
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| Original Primary Outcome Measures ICMJE |
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| Change History | Complete list of historical versions of study NCT00122954 on ClinicalTrials.gov Archive Site | |||
| Current Secondary Outcome Measures ICMJE |
Quality of Life (SF-36) [ Time Frame: baseline to 3 months ] SF-36 is a commonly used measure of health-related quality of life and is well validated in many disease conditions. Responses are self-administered and responses are summed into two subscores, the mental component summary (MCS) and physical component summary (PCS). The SF-36 has eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed on a 0-100 scale. Higher scores represent higher function. |
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| Original Secondary Outcome Measures ICMJE |
Whether the change in IFN-g level is correlated with the change in MADRS scores | |||
| Current Other Outcome Measures ICMJE | Not Provided | |||
| Original Other Outcome Measures ICMJE | Not Provided | |||
| Descriptive Information | ||||
| Brief Title ICMJE | Fish Oil for the Treatment of Depression in Patients With Multiple Sclerosis | |||
| Official Title ICMJE | Fish Oil as an Adjunct Therapy for Depression in Multiple Sclerosis | |||
| Brief Summary | This study will determine whether fish oil can reduce depression in people with multiple sclerosis (MS) who are mild to moderately depressed and are currently taking antidepressant medication. Study hypothesis: Three months of fish oil supplementation will improve depression scores on the Montgomery-Asberg depression rating scale (MADRS) or Beck Depression Inventory (BDI) better than placebo. |
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| Detailed Description | Depression occurs in 50% to 60% of all individuals with MS. Evidence suggests that the omega-3 fatty acids in fish oil supplements can significantly reduce depression with a low risk of side effects. Therefore, fish oil supplements may be a safe adjunctive therapy to improve the therapeutic benefits of antidepressants. This study will determine the effectiveness of fish oil supplements in reducing depression in MS patients who are taking antidepressant medication. This study will last 3 months. Participants will be randomly assigned to receive either fish oil supplements or placebo daily for 3 months. At the end of 3 months, participants who show an improvement in their depressive symptoms will have the option to continue their treatment for an additional 3 months. Participants will do no respond to treatment will be excused from the study. All participants will remain on their antidepressants and MS medication throughout the study. Participants will have weekly study visits. At each visit, participants will be asked about their general health, and self-report scales will be used to assess depressive symptoms. Medication adherence will be monitored by pill counts and through red blood cell fatty acid analysis. Blood collection will occur at study start and at study completion. |
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| Study Type ICMJE | Interventional | |||
| Study Phase | Phase 1 Phase 2 |
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| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Participant, Investigator, Outcomes Assessor Primary Purpose: Treatment |
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| Intervention ICMJE |
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| Publications * |
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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 | 39 | |||
| Completion Date | June 2009 | |||
| Primary Completion Date | June 2009 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years to 85 Years (Adult, Senior) | |||
| Accepts Healthy Volunteers | No | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | United States | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT00122954 | |||
| Other Study ID Numbers ICMJE | K23AT002155-01( U.S. NIH Grant/Contract ) K23AT002155-01 ( U.S. NIH Grant/Contract ) |
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| Has Data Monitoring Committee | Yes | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement |
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| Responsible Party | Lynne Shinto, Oregon Health and Science University | |||
| Study Sponsor ICMJE | Oregon Health and Science University | |||
| Collaborators ICMJE | National Center for Complementary and Integrative Health (NCCIH) | |||
| Investigators ICMJE |
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| PRS Account | Oregon Health and Science University | |||
| Verification Date | May 2017 | |||
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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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