PUFA Augmentation in Treatment of Major Depression - Full Text View

Purpose

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.

Condition	Intervention	Phase
Major Depression	Drug: Polyunsaturated Fatty Acids (PUFA) Drug: Citalopram	Phase III

MedlinePlus related topics:

Antidepressants Depression

ChemIDplus related topics:

Escitalopram Benzetimide Citalopram Citalopram hydrobromide Dexetimide Escitalopram oxalate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Official Title:	PUFA Augmentation in Treatment of Major Depression

Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

Estimated Enrollment:	60
Study Start Date:	September 2003
Study Completion Date:	April 2007
Primary Completion Date:	April 2007 (Final data collection date for primary outcome measure)

Detailed Description:

As per brief summary

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00067301

Locations


United States, California
	Cedars-Sinai Medical Center Dept. of Psychiatry
	Los Angeles, California, United States, 90048

Sponsors and Collaborators

National Center for Complementary and Alternative Medicine (NCCAM)

Investigators


Principal Investigator:	Lev Gertsik, MD	Cedars-Sinai Medical Center

More Information

Study ID Numbers:	R21 AT001077, GertsikL
First Received:	August 14, 2003
Last Updated:	January 23, 2008
ClinicalTrials.gov Identifier:	NCT00067301
Health Authority:	United States: Food and Drug Administration

Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):

depression

citalopram

Celexa

Polyunsaturated Fatty Acids

omega-3

EPA

antidepressants

Study placed in the following topic categories:

Depression

Mood Disorders

Depressive Disorder, Major

Dexetimide

Depressive Disorder

Citalopram

Serotonin

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors

Neurotransmitter Agents

Molecular Mechanisms of Pharmacological Action

Physiological Effects of Drugs

Psychotropic Drugs

Serotonin Uptake Inhibitors

Pharmacologic Actions

Behavioral Symptoms

Serotonin Agents

Mental Disorders

Therapeutic Uses

Antidepressive Agents, Second-Generation

Central Nervous System Agents

Antidepressive Agents

ClinicalTrials.gov processed this record on July 03, 2008

Sponsored by:	National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by:	National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:	NCT00067301