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

NCT00122954 | Completed Phase 1 Results DMC

• 1 other identifier: K23AT002155-01
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis; Depression

Keywords

Fatty Acids, Omega-3; Fish Oils; Complementary Therapies

Outcome Measures

Primary Outcomes (1)

• Montgomery-Asberg Depression Rating Scale (MADRS)

  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).

  baseline to 3 months

Secondary Outcomes (1)

• Quality of Life (SF-36)

  baseline to 3 months

Study Arms (2)

Fish oil concentrate

EXPERIMENTAL

Fish oil concentrate

Drug: Fish oil concentrate

Placebo oil

PLACEBO COMPARATOR

Placebo oil

Drug: Placebo

Interventions

Fish oil concentrate DRUG

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

Also known as: omega-3 fatty acids

Fish oil concentrate

Placebo DRUG

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

Placebo oil

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oregon Health and Science University: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Related Publications (4)

• 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. doi: 10.1176/appi.ajp.159.3.477.

  PMID: 11870016 BACKGROUND

• 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. doi: 10.1016/s0924-977x(03)00032-4.

  PMID: 12888186 BACKGROUND

• 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. doi: 10.1001/archpsyc.59.10.913.

  PMID: 12365878 BACKGROUND

• 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.

  PMID: 26799942 DERIVED

Related Links

• 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

MeSH Terms

Conditions

Multiple Sclerosis; Depression

Interventions

Fatty Acids, Omega-3

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Results Point of Contact

• Title: Lynne Shinto, ND, MPH
• Organization: Oregon Health & Science University

shintol@ohsu.edu

503-494-5035

Study Officials

• Lynne Shinto, ND, MPH

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lynn Shinto, ND, MPH

Study Record Dates

• First Submitted: July 20, 2005
• First Posted: July 22, 2005
• Study Start: July 1, 2005
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: June 8, 2017
• Results First Posted: January 14, 2014

Record last verified: 2017-05

Locations

US (1)