Trial Information

Summary: PUFA for treatment of Major Depression: Differential effects of EPA vs. DHA Therapy

Major depression is a common mental disorder that can have a negative impact on people's lives. Despite the availability of numerous therapies, the current treatment of depression for some people is not ideal. Recent research has shown that an increase in dietary intake of polyunsaturated fatty acids (PUFAs), such as omega-3 fatty acids, may help treat depression. PUFAs are natural supplements. The purpose of this study is to compare the effects of an EAP-enriched PUFA mixture versus a pure DHA PUFA versus a placebo on treating the symptoms of major depression. The study will also investigate the role of the immune and cardiovascular systems with depression.

This double-blind, placebo-controlled study will last 9 weeks including a screening visit, a baseline visit and 4 additional study visits taking place once every 2 weeks. Subjects will be randomly assigned into one of three study groups, 1 receiving EPA, 1 receiving DHA, and one receiving a placebo. In addition, subjects will undergo standard psychiatric assessment to monitor progress, blood samples will be collected three times during the study, a physical exam will be conducted at start and end of study, and subjects will be required to fill out questionnaires concerning mood, side-effects, and food intake.

A study doctor will monitor progress of all subjects throughout study. Subjects will receive $20 for each study visit excluding the screening visit. An additional $20 will be given for each blood draw excluding the screen visit blood draw. The total amount a subject will receive for completion of the entire study is $140. In addition, there will be no charge for visits with study doctor, study medication, or parking.

Patient Inclusion Criteria:

• Subject must be diagnosed with major depression by study staff
• Men and women 18-80

Patient Exclusion Criteria:

• Pregnant or nursing women
• Subjects who, in study staff's judgment, pose a current, serious suicidal or homicidal risk
• Subject has serious or unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease
• Subject has history of seizure disorder
• Subject has been diagnosed with organic mental disorders, schizophrenia, schizoaffective disorder, delusional disorder, psychotic disorders not elsewhere classified, bipolar disorder
• Subject has had substance use disorder, including alcohol, active within the last six months prior to study enrollment
• Subject has history of multiple adverse drug reactions or allergy to study drug
• Subject was mood congruent or mood incongruent psychotic features
• Subject currently using other psychotropic drugs
• Subject shows clinical or laboratory evidence of hypothyroidism
• Subject has failed to respond during the course of their current major depressive episode to at least one adequate antidepressant trial, defined as six weeks or more of treatment with citalopram or its antidepressant equivalent, or who have taken at least 1 gram/day of omega-3 fatty acids
• Subject has had electroconvulsive therapy (ECT) within the 6 months preceding baseline visit
• Subject is taking supplements enriched with omega-3 fatty acids
• Subject who is, at baseline visit, consuming a diet that contains more than 3 grams/day of omega-3 fatty acids
• Subject is taking anticoagulants or has history of a bleeding disorder
• Subject is currently receiving psychotherapy

For more information,

If you would like to learn more about participating in this study, please send an e-mail message using the form below.