Schizoaffective Disorder, Schizophrenia
Conditions
Brief summary
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.
Interventions
DRUGOlanzapine
DRUGQuetiapine
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| 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) | — |
| Treatment-emergent adverse events | — |
| 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 | — |
| 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 | — |
| 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) | — |
| Vital signs and fasting laboratory analytes | — |
| 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: | — |
| To assess within and between group changes in metabolic parameters including fasting glucose, hemoglobin Alc, lipids, and insulin | — |
Countries
United States
Outcome results
None listed