PUFA Augmentation in Treatment of Major Depression

• Status: Completed
• Trial end date: 2007-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine if omega-3 fatty acid EPA will enhance and speed up response to antidepressant therapy with Celexa (Citalopram) in people suffering from Major Depressive Disorder. All patients will receive Celexa, 50% will receive EPA, 50% placebo EPA.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Center for Complementary and Integrative Health (NCCIH)
• Treatments: Citalopram; Dexetimide

Criteria

Inclusion Criteria:

• Meet DSM-IV criteria for current major depression, and have a HAM-D (21 item) score of > 17

• Male or female who, if of child-bearing potential, agrees to use effective contraception including the regular use of contraceptive pills, intra-uterine devices, barrier methods or abstinence

• Age between 18 and 65

• Capable of giving informed consent

Exclusion Criteria:

• Diagnosis of schizophrenia, schizophreniform disorder, schizoaffective disorder, schizotypal disorder, psychotic depression or bipolar disorders

• Current drug or alcohol abuse or dependence, or history of drug or alcohol abuse or dependence within the previous 6 months

• Unstable medical or neurological conditions that are likely to interfere with the treatment of depression

• History of allergy to citalopram or ProEPA, finfish or shellfish

• History of failure of response to citalopram, as documented by an adequate trial of the medication [defined as having been treated with the medication at a dose level typically regarded as adequate (i.e., 40 mg of citalopram per day) for at least 6 weeks]

• History of seizure disorder

• Pregnancy

• Currently on psychotropic medications including antidepressants or neuroleptics

• Active suicidal ideation or other safety issues determined by the clinician to not be suitable for inclusion in the study

• Exposure to treatment with fluoxetine or MAOIs in the previous two months

• Patients on anticoagulant therapy

• Patients with a dietary intake of > 3.0g total omega-3 PUFA/day at baseline