Phase 2
N=57
Decreasing Risk of Coronary Artery Disease in Schizophrenia by Omega-3 Fatty Acid Supplementation
Schizophrenia · Schizoaffective Disorder · Major Depression · Bipolar Disorder · Coronary Artery Disease
Bottom Line
View on ClinicalTrials.gov: NCT00167310 ↗Enrolled (actual)
57
Serious AEs
0.0%
Results posted
Apr 2017
Primary outcome: Primary: Plasma Levels of Triglycerides and Lipoprotein Cholesterol — 155; 182; 12.68; 16.92 mg/dL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Eicosapentaenoic acid (omega-3 fatty acid) (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Pittsburgh
- Primary completion
- Dec 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Plasma Levels of Triglycerides and Lipoprotein Cholesterol |
155; 182; 12.68; 16.92; 14.62; 15.79 | — |
| SECONDARY Plasma Cholesterol Levels in Various Lipoprotein Fractions |
158; 175; 98.14; 109.83; 38.95; 40.22 | — |
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.
Data sourced from ClinicalTrials.gov (NCT00167310). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.