Comparison of Continuing Olanzapine to Switching to Quetiapine in Overweight or Obese Patients With Schizophrenia and Schizoaffective Disorder

Study Overview
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Brief Summary
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The purposes of this study are to determine: The effectiveness of olanzapine as compared to quetiapine in treating and preventing the recurrence of a variety of symptoms of schizophrenia and schizoaffective disorder in patients who are obese or overweight. The safety of olanzapine as compared to quetiapine.

Official Title
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The Comparison of Efficacy and Safety of Continuing Olanzapine to Switching to Quetiapine in Overweight or Obese Patients With Schizophrenia and Schizoaffective Disorder

Conditions
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Schizophrenia, Schizoaffective Disorder

Intervention / Treatment
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* Drug: Olanzapine
* Drug: Quetiapine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: You must be 18-75 years of age and be diagnosed with schizophrenia or schizoaffective disorder You must be able to visit the doctor's office thirteen (13) times over a twenty-six (26) week period Exclusion Criteria: You are a woman and are pregnant or breastfeeding You have an acute or unstable medical illness, such as heart, liver, or kidney disease, or you have a seizure disorder. (Note: If you are uncertain about a particular condition, please discuss it with your physician.) You have a history of allergic reaction or intolerance to olanzapine or quetiapine

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Olanzapine|nan|
|Drug: Quetiapine|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary objective of this study is to assess the treatment difference in time to relapse while on olanzapine 7.5-20 mg/day versus quetiapine 300-800 mg/day in the treatment of obese or overweight patients |  |  | 
| with schizophrenia or schizoaffective disorder. Relapse is defined as the occurrence of at least one of the following three conditions: |  |  | 
| Hospitalization for psychiatric reasons after Visit 2, or |  |  | 
| 20% worsening on the Positive and Negative Syndrome Sale (PANSS) Total and an increase in level of care, as compared to Visit 2, or |  |  | 
| 20% worsening on the PANSS Total compared to Visit 2 and worsening of CGI-S by at least one level compared to Visit 2 and CGI-S level of at least 4 (moderately ill). |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess within and between group changes in metabolic parameters including fasting glucose, hemoglobin Alc, lipids, and insulin |  |  | 
| To assess within and between group changes in weight, waist circumference, BMI, appetite, and prevalence of patients meeting criteria for the metabolic syndrome |  |  | 
| To assess within and between group changes in metabolic parameters (fasting glucose and lipids, and hemoglobin A1c) in a sub-group of patients with pre-existing diabetes prior to study entry |  |  | 
| To assess the effect of olanzapine versus quetiapine on time to discontinuation for any reason, or lack of efficacy or worsening of psychiatric syndromes |  |  | 
| To assess the efficacy of olanzapine versus quetiapine in improving psychopathology of schizophrenia as measured by a mean change from baseline on the PANSS and the Clinical Global Impression-Severity (CGI-S) |  |  | 
| Scale as well as by absolute score of CGI-I (Improvement Scale) |  |  | 
| To assess the efficacy of olanzapine versus quetiapine in improving depressive symptoms as measured by a mean change from baseline on the montgomery-Asberg Depression Rating Scale (MADRS) |  |  | 
| To assess the efficacy of olanzapine versus quetiapine in improving patients' general well being and overall level of functioning as measured by the Short Form 36 Health Survey (SF-36), the Patient Global Impression (PGI)Scale, |  |  | 
| and the Global Assessment of Functioning (GAF) Scale |  |  | 
| To assess patients' opinions on the treatment with olanzapine versus quetiapine as measured by the Drug Attitude Inventory (DAI-10) Scale |  |  | 
| To compare the utilization of medical resources between patients treated with olanzapine or quetiapine |  |  | 
| To assess the safety of olanzapine and quetiapine as determined by: |  |  | 
| Treatment-emergent adverse events |  |  | 
| Vital signs and fasting laboratory analytes |  |  | 
| Extrapyramidal symptoms as measured by the Modified Simpson-Angus Scale, the Barnes Akathisia Rating Scale, and the Abnormal Involuntary Movement Scale (AIMS) |  |  | 
| A sensitivity analysis will be performed on two randomly chosen subsamples of the overall patient population by analyzing the primary objective respectively |  |  |