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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-31

Study Completion Date

2009-06-30

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.

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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.

Conditions

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Multiple Sclerosis Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Fish oil concentrate

Group Type EXPERIMENTAL

Fish oil concentrate

Intervention Type DRUG

fish oil concentrate at a daily dose of 6 grams (2.1 gram EPA and 1.5 gram DHA).

Placebo oil

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

soybean oil with 1% fish oil at a daily dose of 6 grams

Interventions

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Fish oil concentrate

fish oil concentrate at a daily dose of 6 grams (2.1 gram EPA and 1.5 gram DHA).

Intervention Type DRUG

Placebo

soybean oil with 1% fish oil at a daily dose of 6 grams

Intervention Type DRUG

Other Intervention Names

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omega-3 fatty acids

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No