Fish Oil for the Treatment of Depression in Patients With Multiple Sclerosis - Full Text View

Purpose

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	Intervention	Phase
Multiple Sclerosis Depression	Drug: Fish oil concentrate	Phase 1 Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Fish Oil as an Adjunct Therapy for Depression in Multiple Sclerosis

Resource links provided by NLM:

Genetics Home Reference related topics: multiple sclerosis

MedlinePlus related topics: Multiple Sclerosis

Drug Information available for: Fish oil

U.S. FDA Resources

Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:

Fifty Percent Improvement in Montgomery Asberg Depression Rating Scale After 3 Months of Treatment Was Used as the Primary Outcome Measure as This Would be Considered a Clinically Significant Change in Depression [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Montgomery Asberg Depression Rating Scale is a structured interview assessment of depression, designed to be especially sensitive to changes in patients' depression symptoms after antidepressant therapy and is more oriented towards psychic rather than somatic symptoms of depression

Secondary Outcome Measures:

Quality of Life (SF-36) [ Time Frame: 3 months ] [ Designated as safety issue: No ]


Enrollment:	39
Study Start Date:	July 2005
Study Completion Date:	June 2009
Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Fish oil concentrate Fish oil concentrate	Drug: Fish oil concentrate fish oil concentrate (triglyceride form) at a daily dose of 6 grams (1.95 grams of EPA and 1.45 grams of DHA).
Placebo Comparator: Placebo oil Placebo oil

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.

Eligibility


Ages Eligible for Study:	18 Years to 85 Years (Adult, Senior)
Genders Eligible for Study:	Both
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

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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00122954

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

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
Study First Received:	July 20, 2005
Results First Received:	November 25, 2013
Last Updated:	February 27, 2015
Health Authority:	United States: Federal Government

Keywords provided by 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

ClinicalTrials.gov processed this record on September 27, 2016