Fish Oil for the Treatment of Depression in Patients With Multiple Sclerosis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Fish Oil as an Adjunct Therapy for Depression in Multiple Sclerosis

Conditions
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Multiple Sclerosis, Depression

Intervention / Treatment
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* Drug: Fish oil concentrate
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of relapsing-remitting MS Diagnosis of depressive disorder Score between 11 and 30 on the Montgomery-Asberg Depression Rating Scale (MADRS) Score of 25 or greater on the Mini-Mental State Examination (MMSE) Currently taking antidepressant medication for at least 3 months prior to study entry Exclusion Criteria: Currently taking fatty acid supplements Consume more than 6 oz of fish per week within 1 month prior to study entry Severe depression Suicidal thoughts Other psychological disorders Currently taking more than two types of antidepressants Any serious medical condition that would interfere with the study Worsening of MS symptoms or corticosteroid treatment within 1 month prior to study entry Current enrollment in another fish oil study Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fish oil concentrate<br>Fish oil concentrate | Drug: Fish oil concentrate<br>* fish oil concentrate at a daily dose of 6 grams (2.1 gram EPA and 1.5 gram DHA).<br>* Other names: omega-3 fatty acids;|
| Placebo Comparator: Placebo oil<br>Placebo oil | Drug: Placebo<br>* soybean oil with 1% fish oil at a daily dose of 6 grams<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Montgomery-Asberg Depression Rating Scale (MADRS) | 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). | baseline to 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life (SF-36) | 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. | baseline to 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fatty Acids, Omega-3, Fish Oils, Complementary Therapies