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

Study Description

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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.

Study Design

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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

Arms and Interventions

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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

Outcome Measures

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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.

Eligibility Criteria

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

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

Contacts and Locations

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Locations

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)

Investigators

Principal Investigator:	Lynne Shinto, ND, MPH	Oregon Health and Science University

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

Click here for more information about complementary and alternative medicine-related research at Oregon Health and Science University 

Click here for more information about research studies at the Multiple Sclerosis Center of Oregon 

Publications:

Nemets B, Stahl Z, Belmaker RH. Addition of omega-3 fatty acid to maintenance medication treatment for recurrent unipolar depressive disorder. Am J Psychiatry. 2002 Mar;159(3):477-9.

Su KP, Huang SY, Chiu CC, Shen WW. Omega-3 fatty acids in major depressive disorder. A preliminary double-blind, placebo-controlled trial. Eur Neuropsychopharmacol. 2003 Aug;13(4):267-71. Erratum in: Eur Neuropsychopharmacol. 2004 Mar;14(2):173.

Peet M, Horrobin DF. A dose-ranging study of the effects of ethyl-eicosapentaenoate in patients with ongoing depression despite apparently adequate treatment with standard drugs. Arch Gen Psychiatry. 2002 Oct;59(10):913-9.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Shinto L, Marracci G, Mohr DC, Bumgarner L, Murchison C, Senders A, Bourdette D. Omega-3 Fatty Acids for Depression in Multiple Sclerosis: A Randomized Pilot Study. PLoS One. 2016 Jan 22;11(1):e0147195. doi: 10.1371/journal.pone.0147195. eCollection 2016.

Responsible Party:	Lynne Shinto, Lynn Shinto, ND, MPH, Oregon Health and Science University
ClinicalTrials.gov Identifier:	NCT00122954 History of Changes
Other Study ID Numbers:	K23AT002155-01 ( U.S. NIH Grant/Contract )
First Posted:	July 22, 2005
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:

Depression; Depressive Disorder; Sclerosis; Multiple Sclerosis; 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