Overview

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

Status:
Terminated
Trial end date:
2008-12-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Northwestern University
Vanderbilt University Medical Center
Collaborator:
National Alliance for Research on Schizophrenia and Depression
Treatments:
Aripiprazole
Ziprasidone
Criteria
Inclusion criteria

To be eligible, a patient must :

- Be male or female, between 18-65.

- Have a diagnosis of schizophrenia, schizoaffective disorder or bipolar disorder
according to DSM-IV criteria

- Have TG/HDL ratios (>>3.5) and ischemic EKG changes with and without clinical
ischemia, e.g. angina

- Be treated for a minimum of six months with one of six oral antipsychotic medications:
clozapine, haloperidol, olanzapine, quetiapine, risperidone and ziprasidone

- Be willing to change current antipsychotic medication to that chosen by the principal
investigator

- Have a history of compliance with the above medication

- Be Medicaid eligible or maintain insurance covering requested lab procedures

- Be able to provide written informed consent.

Exclusion criteria

A patient will be considered ineligible if he/she:

- Has a diagnosis other than schizophrenia, schizoaffective disorder or bipolar disorder
with psychotic features according to DSM-IV criteria.

- Has a history of noncompliance with prescribed psychiatric medications

- Has a TG/HDL ratio < 3.5 on current medication

- Is uninsured or is unable to self-pay potential costs of required lab procedures not
covered by insurance.

- Is unable to provide written informed consent.

- (Females only) Is pregnant, lactating or plans to become pregnant during study
participation