Omega-3 Fatty Acids for Treating Adults With Major Depression - Full Text View

Purpose

This study will test the effectiveness of two different kinds of omega-3 fatty acid dietary supplements in treating the symptoms of major depression.

Condition	Intervention	Phase
Depression	Dietary Supplement: EPA omega-3 fatty acid Dietary Supplement: DHA omega-3 fatty acid Dietary Supplement: Placebo comparator	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	Omega-3 Fatty Acids for Treatment of Major Depression: Differential Effects of EPA and DHA, and Associated Biochemical and Immune Parameters

Resource links provided by NLM:

Drug Information available for: Omega-3 Fatty Acids

U.S. FDA Resources

Further study details as provided by Cedars-Sinai Medical Center:

Primary Outcome Measures:

Depression rating scale score on HAM-D 17, SCID Mood Module [ Time Frame: Both measured at Week 8 ] [ Designated as safety issue: No ]


Enrollment:	196
Study Start Date:	July 2006
Study Completion Date:	January 2011
Primary Completion Date:	January 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: A Participants will take EPA	Dietary Supplement: EPA omega-3 fatty acid 1 gram per day of an EPA-enriched mixture for 8 weeks
Experimental: B Participants will take DHA	Dietary Supplement: DHA omega-3 fatty acid 1 gram per day of pure DHA for 8 weeks
Placebo Comparator: C Participants will take placebo	Dietary Supplement: Placebo comparator 1 gram per day of an inactive substance for 8 weeks

Detailed Description:

Major depression is a common mental disorder that affects millions of people each year. It can severely impact a person's life, causing someone to often feel sad and hopeless, as well as affect a person's sleep patterns, concentration, and energy levels. Despite the availability of numerous therapies, current treatments are not ideal for some people. Recently, some research has shown that an increase in dietary intake of polyunsaturated fatty acids (PUFAs), such as omega-3 fatty acid, might help treat depression. Eicosapentanoic acid (EPA) and docosahexanoic acid (DHA) are two common types of PUFAs high in omega-3 fatty acids and are available in low dosages in some dietary supplements. The purpose of this study is to compare the effectiveness of an EPA-enriched mixture versus pure DHA versus a placebo in treating the symptoms of major depression.

Participants in this double blind study will be randomly assigned to one of three study groups. Participants assigned to the first study group will receive capsules containing 500 mg of an EPA-enriched omega-3 fatty acid preparation. Participants assigned to the second study group will receive capsules containing 500 mg of pure DHA. Participants assigned to the third study group will receive capsules containing a placebo. The study will last approximately 9 weeks. This will include an initial screening the first week followed by an 8-week period during which all participants will take two capsules of their assigned treatment each morning. Participants will attend a total of six study visits. The initial visit will last approximately 2 hours and will include a psychiatric assessment, urine and blood collection, an electrocardiogram (EKG), and a Food Processor Questionnaire. Participants who qualify for further participation will then enter a 1-week washout period during which they will stop taking any current psychotropic medication. At the second study visit, participants will be assigned to their treatment group. Upon starting assigned treatments, participants will then return for study visits every 2 weeks to report any possible side effects and to complete standard psychiatric assessment tests. All of these study visits will take approximately 1 hour, except the last, which will take 2 hours. In addition to the psychiatric assessment and review of side effects, the final study visit will also include a physical exam and blood collection.

Eligibility


Ages Eligible for Study:	18 Years to 80 Years (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Meets DSM-IV diagnostic criteria for major depressive disorder
A Clinical Global Impression-Severity (CGI-S) score greater than 3
A Baseline Hamilton-D-17 (HAM-D-17) (Hamilton, 1960,1967) score of ³ 15
Willing to use effective forms of contraception

Exclusion Criteria:

Pregnant
Suicidal or homicidal
Serious or unstable medical illness, including cardiovascular, liver, kidney, respiratory, endocrine, neuralgic, or blood disease
History of seizure disorder
History of organic mental disorders, substance abuse, schizophrenia, schizoaffective disorder, delusional disorder, bipolar disorder, or other psychotic disorders
History of inflammatory or auto-immune disorder (e.g., rheumatoid arthritis, multiple sclerosis, or cancer
History of multiple adverse drug reactions or an allergy to the study drugs
Mood-congruent or mood-incongruent psychotic features
Current use of other psychotropic drugs
Clinical or laboratory evidence of hypothyroidism
Failed to respond during the course of current major depressive episode to at least one adequate antidepressant trial, defined as 6 weeks or more of treatment with 40 mg/day of citalopram (or its antidepressant equivalent)
Received electroconvulsive therapy (ECT) within 6 months of study entry
Currently taking supplements enriched with omega-3 fatty acids (e.g., flax seed oil) or has taken at least 1 g/day of omega-3 fatty acids
Consuming a diet that contains more than 3g/day of omega-3 fatty acids at study entry
Taking anticoagulants or history of a bleeding disorder
Patients who are currently in psychotherapy that was initiated within 90 days prior to the study screening visit.
Current infection
Use of systematic corticosteroid or steroid antagonists or other immunosuppressant agents (e.g., cyclosporine, interferon)
Smokes more than 10 cigarettes per day
Taking a vitamin E supplement greater than 400 IU

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00517036

Locations


United States, California
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048

Sponsors and Collaborators

Cedars-Sinai Medical Center

National Institute of Mental Health (NIMH)

Massachusetts General Hospital

Investigators


Principal Investigator:	Mark H. Rapaport, MD	Emory University
Principal Investigator:	David Mischoulon, MD, PhD	Massachusetts General Hospital

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Mischoulon D, Nierenberg AA, Schettler PJ, Kinkead BL, Fehling K, Martinson MA, Hyman Rapaport M. A double-blind, randomized controlled clinical trial comparing eicosapentaenoic acid versus docosahexaenoic acid for depression. J Clin Psychiatry. 2015 Jan;76(1):54-61. doi: 10.4088/JCP.14m08986.


Responsible Party:	Mark Rapaport, Professor, Emory University
ClinicalTrials.gov Identifier:	NCT00517036 History of Changes
Other Study ID Numbers:	R01MH073765 DATR A5-ETMA
Study First Received:	August 14, 2007
Last Updated:	April 2, 2013
Health Authority:	United States: Federal Government

Keywords provided by Cedars-Sinai Medical Center:


Major Depression Omega-3 Major Depressive Disorder

Additional relevant MeSH terms:


Depression Depressive Disorder Depressive Disorder, Major	Behavioral Symptoms Mood Disorders Mental Disorders

ClinicalTrials.gov processed this record on September 30, 2016