Estimating and Reducing the Cardiovascular Risk of Patients With Schizophrenia Drugs From Lipid Measures and Ischemic Electrocardiographic Changes

Phase 3

Terminated

• Conditions: Schizophrenia; Schizoaffective Disorder; Bipolar Disorder
• Interventions: Drug: aripiprazole (Abilify); Drug: ziprasidone (Geodon)

• Registration Number: NCT00288353
• Lead Sponsor: Northwestern University

Brief Summary

The primary goal of this study is to examine the triglyceride/HDL ratio and the ischemic EKG changes in patients with schizophrenia, schizoaffective disorder or bipolar disorder.

Detailed Description

The primary goal of this study is to examine the triglyceride/HDL ratio and the ischemic EKG changes in patients with schizophrenia, schizoaffective disorder or bipolar disorder. The secondary goal is to identify those subjects in the top tertile for the highest risk of IHD as defined by TG/HDL ratios (\>\>3.5) and ischemic EKG changes with and without clinical ischemia, e.g. angina and to see if these risk factors can be reduced or reversed by a change of antipsychotic medication, dietary counseling, enrollment into available exercise groups, etc.

Study Timeline

• Study Start: 2006-01
• Study First Submitted: 2006-02-06
• Study First Submitted QC: 2006-02-06
• Study First Posted: 2006-02-07
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-23
• Last Update Posted: 2017-05-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	aripiprazole (Abilify)	aripiprazole (Abilify)
2	ziprasidone (Geodon)	ziprasidone (Geodon)

Primary Outcome Measures

Name	Time	Method
triglyceride/HDL ratio and the ischemic EKG changes in patients with schizophrenia, schizoaffective disorder or bipolar disorder.	twelve months

Trial Locations

Locations (1)

Vanderbilt Psychiatric Hospital; 🇺🇸 Nashville, Tennessee, United States