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PUFA Augmentation in Treatment of Major Depression

PUFA Augmentation in Treatment of Major Depression

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00067301
Enrollment
60
Registered
2003-08-15
Start date
2003-09-30
Completion date
2007-04-30
Last updated
2008-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Depression

Keywords

depression, citalopram, Celexa, Polyunsaturated Fatty Acids, omega-3, EPA, antidepressants

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

Interventions

DRUGPolyunsaturated Fatty Acids (PUFA)
DRUGCitalopram

Sponsors

National Center for Complementary and Integrative Health (NCCIH)
Lead SponsorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026