Anticonvulsant Mood Stabilizers, Antipsychotic Drugs and the Insulin Resistance Syndrome

Study Overview
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Brief Summary
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The objective of this study is to determine the effect of various mood stabilizers (MS) on the insulin resistance syndrome (IRS; also called the metabolic syndrome) alone and in patients treated with antipsychotic drugs (APDs). Patients will be switched from their current antipsychotic medication to aripiprazole (Abilify) or ziprasidone (Geodon) (unless clinically contraindicated) for comparison with metabolic levels during treatment with the former medication. The metabolic syndrome is an empirical concept based on extensive evidence that a constellation of 5 metabolic abnormalities, e.g. increased cholesterol, hypertension, low HDL, taken together, predict marked increases in the risk of CVD, stroke and some types of cancer.

Official Title
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Anticonvulsant Mood Stabilizers, Antipsychotic Drugs and the Insulin Resistance Syndrome

Conditions
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Schizophrenia, Schizoaffective Disorder, Bipolar Disorder

Intervention / Treatment
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* Drug: ziprasidone vs. aripiprazole
* Drug: aripiprazole vs. ziprasidone


Participation Criteria
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Eligibility Criteria
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Inclusion criteria To be eligible, patients must : Be male or female, age 18-65 Be diagnosed with schizophrenia, schizoaffective disorder or bipolar disorder with psychotic features according to DSM-IV criteria Be currently receiving antipsychotic drugs (clozapine, haloperidol, olanzapine, quetiapine, or risperidone) (APDs) alone, mood stabilizer(s) (MS) alone, or a combination of the two Have a history of compliance with the above medication Have presumptive IRS as indicated by a TG/HDL ratio > 3.5 on current antipsychotic 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 Criteria: -

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: ziprasidone vs. aripiprazole<br>* ziprasidone vs. aripiprazole dosed according to package insert<br>Drug: aripiprazole vs. ziprasidone<br>* aripiprazole vs. ziprasidone dosed according to package insert<br>|
| Active Comparator: 2<br>ziprasidone (Geodon) | Drug: aripiprazole vs. ziprasidone<br>* aripiprazole vs. ziprasidone dosed according to package insert<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HDL Ratio | change in HDL ratio after medication switch | 24 weeks from Baseline | 

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