Estimating and Reducing the Cardiovascular Risk of Patients With Schizophrenia Drugs From Lipid M… (NCT00288353) | Clinical Trial Compass
TerminatedPhase 3
Estimating and Reducing the Cardiovascular Risk of Patients With Schizophrenia Drugs From Lipid Measures and Ischemic Electrocardiographic Changes
Stopped: unable to secure additional funding
United States48 participantsStarted 2006-01
Plain-language 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 disorder.
Who can participate
Age range18 Years – 65 Years
SexALL
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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
What they're measuring
1
Triglyceride/High-density Lipoprotein (TG/HDL) Ratio