Omega-3 Fatty Acids for Treating Adults With Major Depression

Completed · Phase 3 · Has a placebo group

Conditions studied: Depression

In brief

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

Key facts

Study ID

NCT00517036

Run by

Cedars-Sinai Medical Center

People needed

196

Starts

2006-07-01

Expected to finish

2011-01-01

Last updated by the study team

2013-04-04

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Cedars-Sinai Medical Center — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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