Status:
TERMINATED
Estimating and Reducing the Cardiovascular Risk of Patients With Schizophrenia Drugs From Lipid Measures and Ischemic Electrocardiographic Changes
Lead Sponsor:
Northwestern University
Collaborating Sponsors:
National Alliance for Research on Schizophrenia and Depression
Conditions:
Schizophrenia
Schizoaffective Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
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 d...
Detailed Description
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 d...
Eligibility Criteria
Inclusion
- 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 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.
- 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
Exclusion
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00288353
Start Date
January 1 2006
End Date
December 1 2008
Last Update
October 2 2025
Active Locations (1)
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1
Vanderbilt Psychiatric Hospital
Nashville, Tennessee, United States, 37212