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PUFA Augmentation in Treatment of Major Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00067301
Recruitment Status : Completed
First Posted : August 15, 2003
Last Update Posted : January 25, 2008
Information provided by:
National Center for Complementary and Integrative Health (NCCIH)

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.

Condition or disease Intervention/treatment Phase
Major Depression Drug: Polyunsaturated Fatty Acids (PUFA) Drug: Citalopram Phase 3

Detailed Description:
As per brief summary

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Study Type : Interventional  (Clinical Trial)
Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: PUFA Augmentation in Treatment of Major Depression
Study Start Date : September 2003
Actual Primary Completion Date : April 2007
Actual Study Completion Date : April 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Citalopram

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00067301

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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)
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Principal Investigator: Lev Gertsik, MD Cedars-Sinai Medical Center
Layout table for additonal information Identifier: NCT00067301    
Other Study ID Numbers: R21AT001077 ( U.S. NIH Grant/Contract )
First Posted: August 15, 2003    Key Record Dates
Last Update Posted: January 25, 2008
Last Verified: January 2008
Keywords provided by National Center for Complementary and Integrative Health (NCCIH):
Polyunsaturated Fatty Acids
Additional relevant MeSH terms:
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Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs