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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00122954
Recruitment Status : Completed
First Posted : July 22, 2005
Results First Posted : January 14, 2014
Last Update Posted : June 8, 2017
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Lynne Shinto, Oregon Health and Science University

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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Depression Drug: Fish oil concentrate Drug: Placebo Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Fish Oil as an Adjunct Therapy for Depression in Multiple Sclerosis
Study Start Date : July 2005
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Fish oil

Arm Intervention/treatment
Experimental: Fish oil concentrate
Fish oil concentrate
Drug: Fish oil concentrate
fish oil concentrate at a daily dose of 6 grams (2.1 gram EPA and 1.5 gram DHA).
Other Name: omega-3 fatty acids

Placebo Comparator: Placebo oil
Placebo oil
Drug: Placebo
soybean oil with 1% fish oil at a daily dose of 6 grams

Primary Outcome Measures :
  1. Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: 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 :
  1. Quality of Life (SF-36) [ Time Frame: 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00122954

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United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
National Center for Complementary and Integrative Health (NCCIH)
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Principal Investigator: Lynne Shinto, ND, MPH Oregon Health and Science University
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Lynne Shinto, Lynn Shinto, ND, MPH, Oregon Health and Science University Identifier: NCT00122954    
Other Study ID Numbers: K23AT002155-01 ( U.S. NIH Grant/Contract )
K23AT002155-01 ( U.S. NIH Grant/Contract )
First Posted: July 22, 2005    Key Record Dates
Results First Posted: January 14, 2014
Last Update Posted: June 8, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Lynne Shinto, Oregon Health and Science University:
Fatty Acids, Omega-3
Fish Oils
Complementary Therapies
Additional relevant MeSH terms:
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Multiple Sclerosis
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases