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

Depression Clinical Trial

Official title:

Fish Oil as an Adjunct Therapy for Depression in Multiple Sclerosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00122954
• Other study ID #: K23AT002155-01
• Secondary ID: K23AT002155-01
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: July 20, 2005
• Last updated: February 27, 2015
• Start date: July 2005
• Est. completion date: June 2009

Study information

• Verified date: February 2015
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Multiple Sclerosis
• Sclerosis

Intervention

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).

Locations

Country	Name	City	State
United States	Oregon Health and Science University	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Oregon Health and Science University	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	3 months	No
Secondary	Quality of Life (SF-36)		3 months	No

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