PUFA Augmentation in Treatment of Major Depression - Tabular View

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PUFA Augmentation in Treatment of Major Depression

This study has been completed.
Information provided by National Center for Complementary and Alternative Medicine (NCCAM)

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

PUFA Augmentation in Treatment of Major Depression

Official Title ^†

PUFA Augmentation in Treatment of Major Depression

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 Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Primary Outcome Measure ^†

Secondary Outcome Measure ^†

Condition ^†

Major Depression

Intervention ^†

Drug: Polyunsaturated Fatty Acids (PUFA)
Drug: Citalopram

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Completed

Enrollment ^†

Start Date ^†

September 2003

Completion Date

April 2007

Eligibility 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

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00067301

Organization ID

R21 AT001077

Secondary IDs ^††

GertsikL

Study Sponsor ^†

National Center for Complementary and Alternative Medicine (NCCAM)

Collaborators ^††

Investigators ^†

Principal Investigator:

Lev Gertsik, MD

Cedars-Sinai Medical Center

Information Provided By

National Center for Complementary and Alternative Medicine (NCCAM)

Verification Date

January 2008

First Received Date ^†

August 14, 2003

Last Updated Date

January 23, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.