PUFA Augmentation in Treatment of Major Depression

This study has been completed.

First Received: August 14, 2003 Last Updated: January 23, 2008 History of Changes

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

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

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	PUFA Augmentation in Treatment of Major Depression

Resource links provided by NLM:

MedlinePlus related topics: Antidepressants Depression

Drug Information available for: Benzetimide Dexetimide Citalopram hydrobromide Citalopram Escitalopram Escitalopram oxalate

U.S. FDA Resources

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

No publications provided

Study ID Numbers:	R21 AT001077, GertsikL
Study First Received:	August 14, 2003
Last Updated:	January 23, 2008
ClinicalTrials.gov Identifier:	NCT00067301 History of Changes
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

Additional relevant MeSH terms:

Parasympatholytics
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Psychotropic Drugs
Antiparkinson Agents
Depressive Disorder, Major
Cholinergic Agents
Mental Disorders
Therapeutic Uses
Antidepressive Agents, Second-Generation

Dexetimide
Antidepressive Agents
Depression
Depressive Disorder
Citalopram
Serotonin Uptake Inhibitors
Pharmacologic Actions
Behavioral Symptoms
Muscarinic Antagonists
Serotonin Agents
Autonomic Agents
Mood Disorders
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 09, 2009