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Fish Oil for the Treatment of Depression in Patients With Multiple Sclerosis
The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by Oregon Health and Science University.   Recruitment status was  Recruiting

First Received on July 20, 2005.   Last Updated on November 19, 2009   History of Changes
Sponsor: Oregon Health and Science University
Collaborator: National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by: Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT00122954
  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 capsules
Phase I
Phase II

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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Three month change in MADRS scores [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • three month change in interferon-gamma (IFN-g) levels [ Time Frame: 3 months ] [ Designated as safety issue: No ]

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

Estimated Enrollment: 60
Study Start Date: May 2005
Estimated Study Completion Date: June 2009
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Fish oil capsules
    fish oil capsules daily
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 65 Years
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00122954

Contacts
Contact: Lauren E Stuber, BS 503-494-3549 stuberl@ohsu.edu

Locations
United States, Oregon
Oregon Health and Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Rachel R. Frank, BA     503-494-7963     frankra@ohsu.edu    
Contact: Lynne Shinto, ND     503-494-5035     shintol@ohsu.edu    
Principal Investigator: Lynne Shinto, ND            
Sub-Investigator: Dennis Bourdette, MD            
Sponsors and Collaborators
Oregon Health and Science University
Investigators
Principal Investigator: Lynne Shinto, ND Oregon Health and Science University
  More Information

Additional Information:
Publications:
Responsible Party: Lynn H. Shinto, Principal Investigator, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT00122954     History of Changes
Other Study ID Numbers: K23 AT002155-01, K23AT002155-01
Study First Received: July 20, 2005
Last Updated: November 19, 2009
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
Multiple Sclerosis
Sclerosis
Behavioral Symptoms
Mood Disorders
Mental Disorders
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on February 09, 2012