PUFA Augmentation in Treatment of Major Depression

This study has been completed.
Information provided by:
National Center for Complementary and Integrative Health (NCCIH)
ClinicalTrials.gov Identifier:
First received: August 14, 2003
Last updated: January 23, 2008
Last verified: January 2008
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:

Further study details as provided by National Center for Complementary and Integrative Health (NCCIH):

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

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

United States, California
Cedars-Sinai Medical Center Dept. of Psychiatry
Los Angeles, California, United States, 90048
Sponsors and Collaborators
National Center for Complementary and Integrative Health (NCCIH)
Principal Investigator: Lev Gertsik, MD Cedars-Sinai Medical Center
  More Information

ClinicalTrials.gov Identifier: NCT00067301     History of Changes
Other Study ID Numbers: R21AT001077  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 Integrative Health (NCCIH):
Polyunsaturated Fatty Acids

Additional relevant MeSH terms:
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mental Disorders
Mood Disorders
Antidepressive Agents
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Uptake Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on May 01, 2016