This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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

This study has been completed.
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Lynne Shinto, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT00122954
First received: July 20, 2005
Last updated: May 11, 2017
Last verified: May 2017
July 20, 2005
May 11, 2017
July 2005
June 2009   (Final data collection date for primary outcome measure)
Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: baseline to 3 months ]
Higher MADRS scores indicate more severe depression, and the overall score ranges from 0-60. A score of 0-6 indicates symptoms absent, 7-19 indicates mild depression, 20-34 moderate, and > 34 severe. Our primary outcome was 50% or greater improvement on the Montgomery-Asberg Depression Rating Scale (MADRS).
  • Three month change in MADRS scores
  • three month change in interferon-gamma (IFN-g) levels
Complete list of historical versions of study NCT00122954 on ClinicalTrials.gov Archive Site
Quality of Life (SF-36) [ Time Frame: baseline to 3 months ]
SF-36 is a commonly used measure of health-related quality of life and is well validated in many disease conditions. Responses are self-administered and responses are summed into two subscores, the mental component summary (MCS) and physical component summary (PCS). The SF-36 has eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed on a 0-100 scale. Higher scores represent higher function.
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
Intervention Model: Parallel Assignment
Masking: Participant, Investigator, Outcomes Assessor
Primary Purpose: Treatment
  • Multiple Sclerosis
  • Depression
  • Drug: Fish oil concentrate
    fish oil concentrate at a daily dose of 6 grams (2.1 gram EPA and 1.5 gram DHA).
    Other Name: omega-3 fatty acids
  • Drug: Placebo
    soybean oil with 1% fish oil at a daily dose of 6 grams
  • Experimental: Fish oil concentrate
    Fish oil concentrate
    Intervention: Drug: Fish oil concentrate
  • Placebo Comparator: Placebo oil
    Placebo oil
    Intervention: Drug: Placebo

*   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
Sexes Eligible for Study: All
18 Years to 85 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00122954
K23AT002155-01( U.S. NIH Grant/Contract )
K23AT002155-01 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Plan to Share IPD: Undecided
Lynne Shinto, Oregon Health and Science University
Oregon Health and Science University
National Center for Complementary and Integrative Health (NCCIH)
Principal Investigator: Lynne Shinto, ND, MPH Oregon Health and Science University
Oregon Health and Science University
May 2017

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