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.

Condition	Treatment or Intervention	Phase
Major depression	Drug: Polyunsaturated Fatty Acids (PUFA)  Drug: Citalopram	Phase III

Further Study Details: 

Expected Total Enrollment:  60

Ages Eligible for Study:  18 Years   -   65 Years,  Genders Eligible for Study:  Both

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

Sarah Rowe, BS      310-423-0744    rowes@cshs.org

California
      Cedars-Sinai Medical Center Dept. of Psychiatry, Los Angeles,  California,  90048,  United States; Recruiting

Study ID Numbers:  R21AT1077; GertsikL
Record last reviewed:  February 2005
Last Updated:  February 1, 2005
Record first received:  August 14, 2003
ClinicalTrials.gov Identifier:  NCT00067301
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08