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

July 20, 2005
May 7, 2014
May 2005
June 2009   (final data collection date for primary outcome measure)
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
  • three month change in interferon-gamma (IFN-g) levels
  • Three month change in MADRS scores
Complete list of historical versions of study NCT00122954 on ClinicalTrials.gov Archive Site
Quality of Life (SF-36) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Whether the change in IFN-g level is correlated with the change in MADRS scores
Not Provided
Not Provided
 
Fish Oil for the Treatment of Depression in Patients With Multiple Sclerosis
Fish Oil as an Adjunct Therapy for Depression in Multiple Sclerosis

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.

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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Multiple Sclerosis
  • Depression
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
  • Experimental: Fish oil concentrate
    Fish oil concentrate
    Intervention: Drug: Fish oil concentrate
  • Placebo Comparator: Placebo oil
    Placebo oil

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
39
June 2009
June 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00122954
K23 AT002155-01, K23AT002155-01
Yes
Lynne Shinto, Oregon Health and Science University
Oregon Health and Science University
National Center for Complementary and Alternative Medicine (NCCAM)
Principal Investigator: Lynne Shinto, ND, MPH Oregon Health and Science University
Oregon Health and Science University
May 2014

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