PUFA Augmentation in Treatment of Major Depression

National Institutes of Health (NIH)

Status and phase

Completed

Phase 3

Conditions

Major Depression

Treatments

Drug: Polyunsaturated Fatty Acids (PUFA)

Drug: Citalopram

Study type

Interventional

Funder types

NIH

Identifiers

NCT00067301

R21AT001077

GertsikL

Details and patient eligibility

About

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.

Full description

As per brief summary

Sex

All

Ages

18 to 65 years old

Volunteers

No 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