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

Status Completed

Clinical Trial 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).

Clinical Trial Description

We propose to study the effects of EPA (2 g of EPA in 4 x 500 mg capsules daily) compared to placebo supplementation in clinically-stable schizophrenic patients being treated with statins (n=30 each) for 4 months using a randomized, double-blind design. The National Cholesterol Education Program Adult Treatment Panel III guidelines will be used to select those patients with CAD risk to participate. Clinical assessments and comprehensive assessment of the risk for CAD, including plasma total, high-density lipoprotein (HDL)- (HDL2- and HDL3-), low-density lipoprotein (LDL)- (LDL-Real-, Lp(a)-, and IDL-), and VLDL- (VLDL1,2- and VLDL3-) cholesterol, plasma triglycerides, as well as plasma homocysteine and high sensitivity C-reactive protein, will be conducted at baseline, 1 month, 2 months and 4 months after supplementation. It is anticipated that patients who receive EPA supplementation will have significantly greater reduction in plasma triglycerides and LDL4-cholesterol, and increases in HDL2-cholesterol measures, as well as improvements in psychopathology severity than those patients receiving placebo. If indeed EPA is effective in decreasing the risk of CAD, any psychiatric benefits from EPA supplementation will be a further boon to the patients and the treatment team. A tremendous advantage to the clinical use of EPA includes low cost, no significant side effects, and ease of use. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00167310
Study type	Interventional
Source	University of Pittsburgh
Contact
Status	Completed
Phase	Phase 2
Start date	September 2005
Completion date	December 2015

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms