Decreasing Risk of Coronary Artery Disease in Schizophrenia by Omega-3 Fatty Acid Supplementation

Completed · Phase 2 · Has a placebo group

Conditions studied: Schizophrenia, Schizoaffective Disorder, Major Depression, Bipolar Disorder, Coronary Artery Disease

In brief

The purpose of this study is to determine whether the administration of omega-3 polyunsaturated fatty acids, particularly eicosapentaenoic acid (EPA), can be useful both to reduce coronary artery disease (CAD) risk and illness severity in clinically-stable patients with schizophrenia (or schizoaffective disorder), major depression or bipolar disorder (depressed phase) being treated with lipid lowering drugs (e.g., statins).

Key facts

Study ID: NCT00167310
Run by: University of Pittsburgh
People needed: 57
Starts: 2005-09-01
Expected to finish: 2015-12-01
Last updated by the study team: 2017-04-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patients meeting Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition (DSM-IV) criteria for schizophrenia (or schizoaffective disorder), major depression, or bipolar (depressed phase) disorder who are treated with antipsychotic, antidepressant or antimanic drugs and a lipid-lowering drug (statin) for 2 months or longer will be screened to participate in the proposed project.
Based upon the CAD risk determinants (see below) and the National Cholesterol Education Program (NCEP) recommendation of goals for LDL-lowering therapy, the investigators will only enroll schizophrenic patients with baseline (before statin treatment) LDL-cholesterol exceeding:
70 mg/dL having CAD and CAD risk equivalents, e.g., peripheral arterial disease, abdominal aortic aneurysm, symptomatic carotid artery disease, and diabetes, as well as multiple risk factors that confer a 10-year risk for CAD > 20%
130 mg/dL having 2 or more risk factors; and
160 mg/dL having less than 2 risk factors to participate in the EPA trial.
In addition, these CAD-risk patients have not reached the NCEP goal level within the past year following statin treatment.
Risk factors for CAD. The NCEP Expert Panel (NIH Publication No. 01-3670, May 2001) on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III or ATPIII) recognizes the following CAD risk factors:
being male, 45 years or older, or being female 55 years or older;
family history of premature CAD;
current cigarette smoking;
hypertension with 140/90 mmHg or greater; and
low HDL-cholesterol (less than 40 mg/dL).

You may not qualify if…

Patients with history of bleeding disorders, current drug or alcohol abuse (within one month), neurological disorders (including head injury with loss of consciousness for greater than 10 minutes), antisocial personality disorder, borderline personality disorder, or mental retardation as indicated in medical records
Patients who are pregnant (as determined by urine pregnancy test)
Patients who have already achieved their NCEP goal in terms of their lipid profile (as indicated in laboratory tests) will be excluded.

Where it is running

VA Pittsburgh Healthcare System (University Drive) — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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