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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Schizophrenia, Schizoaffective Disorder, Bipolar Disorder

Intervention / Treatment
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* Drug: aripiprazole (Abilify)
* Drug: ziprasidone (Geodon)


Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>aripiprazole (Abilify) | Drug: aripiprazole (Abilify)<br>* active drug given daily as per package insert according to standard clinical care for twelve month duration of study. Subject will be switched from current antipsychotic to this drug or other randomized study medication.<br>|
| Active Comparator: 2<br>ziprasidone (Geodon) | Drug: ziprasidone (Geodon)<br>* active medication will be given daily as per package insert according to standard clinical care for the twelve month duration of the study. Subject will be switched from current antipsychotic medication to this medication or the other randomized medication.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| triglyceride/HDL ratio and the ischemic EKG changes in patients with schizophrenia, schizoaffective disorder or bipolar disorder. |  | twelve months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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schizophrenia, schizoaffective disorder, bipolar disorder, metabolic syndrome