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Omega-3 Fatty Acids for Treating Adults With Major Depression

This study has been completed.
Sponsor:
Collaborators:
Massachusetts General Hospital
Information provided by (Responsible Party):
Mark Rapaport, Emory University
ClinicalTrials.gov Identifier:
NCT00517036
First received: August 14, 2007
Last updated: April 2, 2013
Last verified: April 2013

August 14, 2007
April 2, 2013
July 2006
January 2011   (final data collection date for primary outcome measure)
Depression rating scale score on HAM-D 17, SCID Mood Module [ Time Frame: Both measured at Week 8 ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00517036 on ClinicalTrials.gov Archive Site
Not Provided
Depression rating scale score [ Time Frame: Measured at Week 8 ]
Not Provided
Not Provided
 
Omega-3 Fatty Acids for Treating Adults With Major Depression
Omega-3 Fatty Acids for Treatment of Major Depression: Differential Effects of EPA and DHA, and Associated Biochemical and Immune Parameters

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

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Depression
  • Dietary Supplement: EPA omega-3 fatty acid
    1 gram per day of an EPA-enriched mixture for 8 weeks
  • Dietary Supplement: DHA omega-3 fatty acid
    1 gram per day of pure DHA for 8 weeks
  • Dietary Supplement: Placebo comparator
    1 gram per day of an inactive substance for 8 weeks
  • Experimental: A
    Participants will take EPA
    Intervention: Dietary Supplement: EPA omega-3 fatty acid
  • Experimental: B
    Participants will take DHA
    Intervention: Dietary Supplement: DHA omega-3 fatty acid
  • Placebo Comparator: C
    Participants will take placebo
    Intervention: Dietary Supplement: Placebo comparator
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
196
January 2011
January 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00517036
R01 MH073765, R01MH073765, DATR A5-ETMA
Yes
Mark Rapaport, Emory University
Cedars-Sinai Medical Center
  • National Institute of Mental Health (NIMH)
  • Massachusetts General Hospital
Principal Investigator: Mark H. Rapaport, MD Emory University
Principal Investigator: David Mischoulon, MD, PhD Massachusetts General Hospital
Cedars-Sinai Medical Center
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP