PUFA Augmentation in Treatment of Major Depression

Phase 3

Completed

• Conditions: Major Depression

• Registration Number: NCT00067301
• Lead Sponsor: National Center for Complementary and Integrative Health (NCCIH)

Brief 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.

Detailed Description

As per brief summary

Study Timeline

• Study First Submitted: 2003-08-14
• Study First Submitted QC: 2003-08-14
• Study First Posted: 2003-08-15
• Study Start: 2003-09
• Primary Completion: 2007-04
• Study Completion: 2007-04
• Status Verified: 2008-01
• Last Update Submitted: 2008-01-23
• Last Update Posted: 2008-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Trial Locations

Locations (1)

Cedars-Sinai Medical Center Dept. of Psychiatry; 🇺🇸 Los Angeles, California, United States