NCT00096798CompletedPhase 3
A Double-Blind, Placebo-Controlled Study of Ethyl Eicosapentanoic Acid (Ethyl-EPA) in Major Depressive Disorder
National Center for Complementary and Integrative Health (NCCIH)1 site in 1 country80 target enrollmentStarted: September 1, 2001Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Alleviation of depressive symptoms
Study Overview
Brief Summary
The purpose of this study is to examine the effectiveness of ethyl-eicosapentanoic acid (ethyl-EPA), an omega-3 fatty acid, in treating depression.
Detailed Description
Evidence suggests that omega-3 fatty acids may help reduce symptoms of depression. This study will determine whether ethyl-EPA, an omega-3 fatty acid, can be used safely and effectively to treat major depression.
Participants will be randomly assigned to receive either ethyl EPA-containing pills or placebo daily for 8 weeks. Each week, participants will be asked to complete questionnaires which will be used to assess the severity of their depression.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Major depressive disorder
Exclusion Criteria
- •Serious comorbid psychiatric disorder
- •Unstable medical illness
- •Prior use of any omega-3 fatty acid product
Outcomes
Primary Outcomes
Alleviation of depressive symptoms
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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