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

Stopped early · Phase 3

Conditions studied: Schizophrenia, Schizoaffective Disorder, Bipolar Disorder

In brief

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

Key facts

Study ID

NCT00288353

Run by

Northwestern University

People needed

48

Starts

2006-01-01

Expected to finish

2008-12-01

Last updated by the study team

2025-10-02

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 Diagnostic and Statistical Manual (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.

You may not qualify if…

• 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

Where it is running

• Vanderbilt Psychiatric Hospital — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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