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

August 14, 2003
January 23, 2008
September 2003
April 2007   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00067301 on ClinicalTrials.gov Archive Site
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PUFA Augmentation in Treatment of Major Depression
PUFA Augmentation in Treatment of Major Depression

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.

As per brief summary

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Major Depression
  • Drug: Polyunsaturated Fatty Acids (PUFA)
  • Drug: Citalopram
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
April 2007
April 2007   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00067301
R21 AT001077, GertsikL
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National Center for Complementary and Alternative Medicine (NCCAM)
Not Provided
Principal Investigator: Lev Gertsik, MD Cedars-Sinai Medical Center
National Center for Complementary and Alternative Medicine (NCCAM)
January 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP