PUFA Augmentation in Treatment of Major Depression

Major Depression Clinical Trial

Official title:

PUFA Augmentation in Treatment of Major Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00067301
• Other study ID #: R21AT001077
• Secondary ID: GertsikL
• Status: Completed
• Phase: Phase 3
• First received: August 14, 2003
• Last updated: January 23, 2008
• Start date: September 2003
• Est. completion date: April 2007

Study information

• Verified date: January 2008
• Source: National Center for Complementary and Integrative Health (NCCIH)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

As per brief summary

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 2007
• Est. primary completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depression

Intervention

Drug:
• Polyunsaturated Fatty Acids (PUFA)

• Citalopram

Locations

Country	Name	City	State
United States	Cedars-Sinai Medical Center Dept. of Psychiatry	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States,