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PUFA Augmentation in Treatment of Major Depression

Primary Purpose

Major Depression

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Polyunsaturated Fatty Acids (PUFA)
Citalopram
Sponsored by
National Center for Complementary and Integrative Health (NCCIH)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depression focused on measuring depression, citalopram, Celexa, Polyunsaturated Fatty Acids, omega-3, EPA, antidepressants

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cedars-Sinai Medical Center Dept. of Psychiatry

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
August 14, 2003
Last Updated
January 23, 2008
Sponsor
National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT00067301
Brief Title
PUFA Augmentation in Treatment of Major Depression
Official Title
PUFA Augmentation in Treatment of Major Depression
Study Type
Interventional

2. Study Status

Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
September 2003 (undefined)
Primary Completion Date
April 2007 (Actual)
Study Completion Date
April 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

5. Study Description

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.
Detailed Description
As per brief summary

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depression
Keywords
depression, citalopram, Celexa, Polyunsaturated Fatty Acids, omega-3, EPA, antidepressants

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
60 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Polyunsaturated Fatty Acids (PUFA)
Intervention Type
Drug
Intervention Name(s)
Citalopram

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lev Gertsik, MD
Organizational Affiliation
Cedars-Sinai Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cedars-Sinai Medical Center Dept. of Psychiatry
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34817851
Citation
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.
Results Reference
derived

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PUFA Augmentation in Treatment of Major Depression

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