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PUFA Augmentation in Treatment of Major Depression

This study has been completed.
Sponsor:
Information provided by:
National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:
NCT00067301
First received: August 14, 2003
Last updated: January 23, 2008
Last verified: January 2008
History of Changes
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: PUFA Augmentation in Treatment of Major Depression

Resource links provided by NLM:

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

ClinicalTrials.gov Identifier: NCT00067301     History of Changes
Other Study ID Numbers: R21 AT001077, GertsikL
Study First Received: August 14, 2003
Last Updated: January 23, 2008
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:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Citalopram
Dexetimide
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
 Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Physiological Effects of Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents

ClinicalTrials.gov processed this record on May 21, 2013