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

This study has been completed.
Sponsor:
Collaborator:
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, 2014
Last verified: May 2014
  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:


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: May 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).
Other Name: Fish oil concentrate
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
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
Investigators
Principal Investigator: Lynne Shinto, ND, MPH Oregon Health and Science University
  More Information

Additional Information:
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
Results First Received: November 25, 2013
Last Updated: May 7, 2014
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 August 28, 2014