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

This study has been completed.

Sponsor:

Collaborator:

National Center for Complementary and Alternative Medicine (NCCAM)

Information provided by (Responsible Party):

Lynne Shinto, Oregon Health and Science University

ClinicalTrials.gov Identifier:

NCT00122954

First received: July 20, 2005

Last updated: May 7, 2013

Last verified: May 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

July 20, 2005

Last Updated Date

May 7, 2013

Start Date ^ICMJE

May 2005

Primary Completion Date

June 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Change in MADRS scores and interferon (IFN-g) levels [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

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

Change History

Complete list of historical versions of study NCT00122954 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Whether the change in IFN-g level is correlated with the change in MADRS scores [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Whether the change in IFN-g level is correlated with the change in MADRS scores

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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 ^ICMJE

Interventional

Study Phase

Phase 1
Phase 2

Study Design ^ICMJE

Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment

Condition ^ICMJE

Multiple Sclerosis
Depression

Intervention ^ICMJE

Drug: Fish oil capsules

fish oil capsules daily

Study Arm (s)

Placebo Comparator: Fish Oil vs. Placebo

Half of the sample size received Fish Oil as the intervention and the other half received placebo.

Intervention: Drug: Fish oil capsules

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

June 2009

Primary Completion Date

June 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00122954

Other Study ID Numbers ^ICMJE

K23 AT002155-01, K23AT002155-01

Has Data Monitoring Committee

Yes

Responsible Party

Lynne Shinto, Oregon Health and Science University

Study Sponsor ^ICMJE

Oregon Health and Science University

Collaborators ^ICMJE

National Center for Complementary and Alternative Medicine (NCCAM)

Investigators ^ICMJE

Principal Investigator:

Lynne Shinto, ND

Oregon Health and Science University

Information Provided By

Oregon Health and Science University

Verification Date

May 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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