Multiple Sclerosis Clinical Trial

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

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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Full 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.

View Eligibility Criteria

Eligibility Criteria

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

Study is for people with:

Multiple Sclerosis

Phase:

Phase 1

Estimated Enrollment:

39

Study ID:

NCT00122954

Recruitment Status:

Completed

Sponsor:

Oregon Health and Science University

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There is 1 Location for this study

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Oregon Health and Science University
Portland Oregon, 97239, United States

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Study is for people with:

Multiple Sclerosis

Phase:

Phase 1

Estimated Enrollment:

39

Study ID:

NCT00122954

Recruitment Status:

Completed

Sponsor:


Oregon Health and Science University

How clear is this clinincal trial information?

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