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

Phase 1

Completed

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.

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Fish oil concentrate	Fish oil concentrate	Fish oil concentrate
Placebo oil	Placebo	Placebo oil

Primary Outcome Measures

Name	Time	Method
Montgomery-Asberg Depression Rating Scale (MADRS)	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).

Secondary Outcome Measures

Name	Time	Method
Quality of Life (SF-36)	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.