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

Oregon Health & Science University (OHSU)

Status and phase

Completed

Phase 2

Phase 1

Conditions

Multiple Sclerosis

Depression

Treatments

Drug: Fish oil concentrate

Drug: Placebo

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00122954

K23AT002155-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

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.

Enrollment

39 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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