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

Condition(s) targeted: Multiple Sclerosis; Depression

Intervention: Fish oil capsules (Drug)

Phase: Phase 1/Phase 2

Status: Recruiting

Sponsored by: National Center for Complementary and Alternative Medicine (NCCAM)

Official(s) and/or principal investigator(s):
Lynne Shinto, ND, Principal Investigator, Affiliation: Oregon Health and Science University

Overall contact:
Lauren E Stuber, BS, Phone: 503-494-3549, Email: stuberl@ohsu.edu

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.

Official title: Fish Oil as an Adjunct Therapy for Depression in Multiple Sclerosis

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome:

Three month change in MADRS scores

three month change in interferon-gamma (IFN-g) levels

Secondary outcome: Whether the change in IFN-g level is correlated with the change in MADRS scores

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.

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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

Lauren E Stuber, BS, Phone: 503-494-3549, Email: stuberl@ohsu.edu

Oregon Health and Science University, Portland, Oregon 97239, United States; Recruiting
Rachel R. Frank, BA, Phone: 503-494-7963, Email: frankra@ohsu.edu
Lynne Shinto, ND, Phone: 503-494-5035, Email: shintol@ohsu.edu
Lynne Shinto, ND, Principal Investigator
Dennis Bourdette, MD, Sub-Investigator

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

Related 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.

Starting date: May 2005
Ending date: June 2009
Last updated: October 9, 2008