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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
  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 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group 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:

Drug Information available for: Fish oil
U.S. FDA Resources

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

Primary Outcome Measures:
  • Change in MADRS scores and interferon (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 ]

Enrollment: 50
Study Start Date: May 2005
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Fish Oil vs. Placebo
Half of the sample size received Fish Oil as the intervention and the other half received placebo.
 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

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 Alternative Medicine (NCCAM)
Investigators
Principal Investigator: Lynne Shinto, ND Oregon Health and Science University
  More Information

Additional Information:
Click here for more information about complementary and alternative medicine-related research at Oregon Health and Science University  This link exits the ClinicalTrials.gov site
Click here for more information about research studies at the Multiple Sclerosis Center of Oregon  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Lynne Shinto, Lynn Shinto, ND, MPH, 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: May 7, 2013
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 May 19, 2013