Fish Oil for the Treatment of Depression in Patients With Multiple Sclerosis
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.
Drug: Fish oil concentrate
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Fish Oil as an Adjunct Therapy for Depression in Multiple Sclerosis|
- Fifty Percent Improvement in Montgomery Asberg Depression Rating Scale After 3 Months of Treatment Was Used as the Primary Outcome Measure as This Would be Considered a Clinically Significant Change in Depression [ Time Frame: 3 months ] [ Designated as safety issue: No ]Montgomery Asberg Depression Rating Scale is a structured interview assessment of depression, designed to be especially sensitive to changes in patients' depression symptoms after antidepressant therapy and is more oriented towards psychic rather than somatic symptoms of depression
- Quality of Life (SF-36) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
|Study Start Date:||July 2005|
|Study Completion Date:||June 2009|
|Primary Completion Date:||June 2009 (Final data collection date for primary outcome measure)|
Experimental: Fish oil concentrate
Fish oil concentrate
Drug: Fish oil concentrate
fish oil concentrate (triglyceride form) at a daily dose of 6 grams (1.95 grams of EPA and 1.45 grams of DHA).
Other Name: Fish oil concentrate
Placebo Comparator: Placebo oil
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00122954
|United States, Oregon|
|Oregon Health and Science University|
|Portland, Oregon, United States, 97239|
|Principal Investigator:||Lynne Shinto, ND, MPH||Oregon Health and Science University|