At a glance
ClinicalIndex Comparison Record- ✓Diagnosis of schizophrenia, schizoaffective disorder, major depression, or bipolar (depressed phase) disorder treated with antipsychotic, antidepressant, or antimanic drugs
- ✓On lipid-lowering statin therapy for 2 months or longer
- ✓Baseline LDL-cholesterol ≥70 mg/dL with CAD and CAD risk equivalents (peripheral arterial disease, abdominal aortic aneurysm, symptomatic carotid artery disease, diabetes) or multiple risk factors with 10-year CAD risk >20%
- ✓Baseline LDL-cholesterol ≥130 mg/dL with 2 or more CAD risk factors
- ✕History of bleeding disorders
- ✕Current drug or alcohol abuse within one month
- ✕Neurological disorders including head injury with loss of consciousness >10 minutes
- ✕Antisocial personality disorder or borderline personality disorder
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
CAD Risk in Schizophrenia: Effect of Omega-3 Fatty Acid Supplementation
In Brief
A Phase 2 clinical trial evaluating Eicosapentaenoic acid (omega-3 fatty acid) and Placebo for Schizophrenia and 4 related conditions. Completed, enrolled 57 participants across 1 site.
Detailed 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).
Study Details
Timeline
Interventions
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