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

• ClinicalTrials.gov Identifier: NCT00122954
• Recruitment Status: Completed
• First Posted: July 22, 2005
• Results First Posted: January 14, 2014
• Last Update Posted: June 8, 2017
• Sponsor: Oregon Health and Science University
• Collaborator: National Center for Complementary and Integrative Health (NCCIH)
• Information provided by (Responsible Party): Lynne Shinto, Oregon Health and Science University

Tracking Information

• First Submitted Date: July 20, 2005
• First Posted Date: July 22, 2005
• Results First Submitted Date: November 25, 2013
• Results First Posted Date: January 14, 2014
• Last Update Posted Date: June 8, 2017
• Study Start Date: July 2005
• Actual Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 11, 2017)

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).

Original Primary Outcome Measures (submitted: July 21, 2005)

• Three month change in MADRS scores
• three month change in interferon-gamma (IFN-g) levels

Current Secondary Outcome Measures (submitted: May 11, 2017)

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.

• Original Secondary Outcome Measures (submitted: July 21, 2005): Whether the change in IFN-g level is correlated with the change in MADRS scores
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Fish Oil for the Treatment of Depression in Patients With Multiple Sclerosis
• Official Title: Fish Oil as an Adjunct Therapy for Depression in Multiple Sclerosis

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.

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 Type: Interventional
• Study Phase: Phase 1; Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Treatment

Condition

• Multiple Sclerosis
• Depression

Intervention

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

Study Arms

• Experimental: Fish oil concentrate
  Fish oil concentrate
  Intervention: Drug: Fish oil concentrate
• Placebo Comparator: Placebo oil
  Placebo oil
  Intervention: Drug: Placebo

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.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 7, 2014): 39
• Original Enrollment (submitted: July 21, 2005): 60
• Actual Study Completion Date: June 2009
• Actual Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 85 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00122954
• Other Study ID Numbers: K23AT002155-01( U.S. NIH Grant/Contract ); K23AT002155-01 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Responsible Party: Lynne Shinto, Oregon Health and Science University
• Study Sponsor: Oregon Health and Science University
• Collaborators: National Center for Complementary and Integrative Health (NCCIH)

Investigators

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

• PRS Account: Oregon Health and Science University
• Verification Date: May 2017