Ethyl Eicosapentanoic Acid (Ethyl-EPA) for Treating Major Depression

• ClinicalTrials.gov Identifier: NCT00096798
• Recruitment Status: Completed
• First Posted: November 16, 2004
• Last Update Posted: January 17, 2008
• Sponsor: National Center for Complementary and Integrative Health (NCCIH)
• Information provided by: National Center for Complementary and Integrative Health (NCCIH)

Tracking Information

• First Submitted Date: November 15, 2004
• First Posted Date: November 16, 2004
• Last Update Posted Date: January 17, 2008
• Study Start Date: September 2001
• Actual Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: June 23, 2005): Alleviation of depressive symptoms
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Ethyl Eicosapentanoic Acid (Ethyl-EPA) for Treating Major Depression
• Official Title: A Double-Blind, Placebo-Controlled Study of Ethyl Eicosapentanoic Acid (Ethyl-EPA) in Major Depressive Disorder
• 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 Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double; Primary Purpose: Treatment

Condition

• Depressive Disorder
• Depression

• Intervention: Drug: Ethyl-eicosapentanoic acid (ethyl-EPA)
• Study Arms: Not Provided
• Publications *: Mischoulon D, Papakostas GI, Dording CM, Farabaugh AH, Sonawalla SB, Agoston AM, Smith J, Beaumont EC, Dahan LE, Alpert JE, Nierenberg AA, Fava M. A double-blind, randomized controlled trial of ethyl-eicosapentaenoate for major depressive disorder. J Clin Psychiatry. 2009 Dec;70(12):1636-44. doi: 10.4088/JCP.08m04603. Epub 2009 Aug 25.

Recruitment Information

• Recruitment Status: Completed
• Estimated Enrollment (submitted: June 23, 2005): 80
• Original Enrollment: Same as current
• Actual Study Completion Date: August 2007
• Actual Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Major depressive disorder

Exclusion Criteria:

• Serious comorbid psychiatric disorder
• Unstable medical illness
• Prior use of any omega-3 fatty acid product

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00096798
• Other Study ID Numbers: K23AT001129( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Not Provided
• Study Sponsor: National Center for Complementary and Integrative Health (NCCIH)
• Collaborators: Not Provided

Investigators

• Principal Investigator: David Mischoulon, MD, PhD; Massachusetts General Hospital

• PRS Account: National Center for Complementary and Integrative Health (NCCIH)
• Verification Date: January 2008