Decreasing Risk of Coronary Artery Disease in Schizophrenia by Omega-3 Fatty Acid Supplementation
Condition: Schizophrenia; Schizoaffective Disorder; Major Depression; Bipolar Disorder; Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Schizophrenia; Bipolar Disorder; Psychotic Disorders
Intervention: Eicosapentaenoic acid (omega-3 fatty acid); Placebo
Intervention description: 2 g of Eicosapentaenoic acid in 4 x 500 mg capsules daily for baseline, 1 month, 2 months and 4 months; 2 g of Placebo (soy bean oil) in 4 x 500 mg capsules daily for baseline, 1 month, 2 months and 4 months
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 57.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Omega-3 fatty acids; Statins; Antipsychotic drug; Antidepressant drug; Antimanic drug; Placebos; Double-blind method; Bipolar (depressed phase)

Summary:

      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).
    

Eligibility criteria:

        Inclusion Criteria:

          -  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).

        Exclusion Criteria:

          -  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.