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Clinical Trial: Fish Oil for the Treatment of Depression in Patients with Multiple Sclerosis
This study is currently recruiting patients.
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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 |
MedlinePlus related topics: Depression; Multiple Sclerosis
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Fish Oil As an Adjunct Therapy for Depression in Multiple Sclerosis
Secondary Outcomes: Whether the change in IFN-g level is correlated with the change in MADRS scores
Expected Total Enrollment: 60
Study start: May 2005; Expected completion: June 2009
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
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
Location and Contact Information
Oregon
Oregon Health and Science University, Portland, Oregon, 97239, United States; Recruiting
Lynne Shinto, ND 503-494-5035 shintol@ohsu.edu
Lynne Shinto, ND, Principal Investigator
Dennis Bourdette, MD, Sub-Investigator
Lynne Shinto, ND, Principal Investigator, Oregon Health and Science University
More Information
Click here for more information about complementary and alternative medicine-related research at Oregon Health and Science University
Click here for more information about research studies at the Multiple Sclerosis Center of Oregon
Publications
Nemets B, Stahl Z, Belmaker RH. Addition of omega-3 fatty acid to maintenance medication treatment for recurrent unipolar depressive disorder. Am J Psychiatry. 2002 Mar;159(3):477-9.
Su KP, Huang SY, Chiu CC, Shen WW. Omega-3 fatty acids in major depressive disorder. A preliminary double-blind, placebo-controlled trial. Eur Neuropsychopharmacol. 2003 Aug;13(4):267-71. Erratum in: Eur Neuropsychopharmacol. 2004 Mar;14(2):173.
Peet M, Horrobin DF. A dose-ranging study of the effects of ethyl-eicosapentaenoate in patients with ongoing depression despite apparently adequate treatment with standard drugs. Arch Gen Psychiatry. 2002 Oct;59(10):913-9.
Record last reviewed: July 2005
Last Updated: July 25, 2005
Record first received: July 21, 2005
ClinicalTrials.gov Identifier: NCT00122954
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-07-26
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