PUFA Augmentation in Treatment of Major Depression

NCT ID: NCT00067301

Last Updated: 2008-01-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-09-30
• Study Completion Date: 2007-04-30

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

Conditions

Major Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Polyunsaturated Fatty Acids (PUFA)

Intervention Type: DRUG

Citalopram

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role: lead

Principal Investigators

Lev Gertsik, MD

Role: PRINCIPAL_INVESTIGATOR

Cedars-Sinai Medical Center

Locations

Cedars-Sinai Medical Center Dept. of Psychiatry

Los Angeles, California, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 34817851 (View on PubMed)

Other Identifiers

GertsikL

Identifier Type: -

Identifier Source: secondary_id

R21AT001077

Identifier Type: NIH

Identifier Source: org_study_id

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