PUFA Augmentation in Treatment of Major Depression
2 other identifiers
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Sep 2003
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 14, 2003
CompletedFirst Posted
Study publicly available on registry
August 15, 2003
CompletedStudy Start
First participant enrolled
September 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2007
CompletedJanuary 25, 2008
January 1, 2008
3.6 years
August 14, 2003
January 23, 2008
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cedars-Sinai Medical Center Dept. of Psychiatry
Los Angeles, California, 90048, United States
Related Publications (1)
Appleton KM, Voyias PD, Sallis HM, Dawson S, Ness AR, Churchill R, Perry R. Omega-3 fatty acids for depression in adults. Cochrane Database Syst Rev. 2021 Nov 24;11(11):CD004692. doi: 10.1002/14651858.CD004692.pub5.
PMID: 34817851DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lev Gertsik, MD
Cedars-Sinai Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
Study Record Dates
First Submitted
August 14, 2003
First Posted
August 15, 2003
Study Start
September 1, 2003
Primary Completion
April 1, 2007
Study Completion
April 1, 2007
Last Updated
January 25, 2008
Record last verified: 2008-01