Efficacy of High Dose Olanzapine in a Controlled Fixed Dose-Response Trial for the Treatment of Schizophrenia and Schizoaffective Disorder

简要总结

主要结局

次要结局

• To assess the dose response efficacy of olanzapine in improving psychopathology of schizophrenia as measured by a mean change from baseline on the PANSS subscores and Clinical Global Impression-Severity(CGI-S) Scale as well as by the absolute score
• of CGI-I (Improvement) Scale
• To assess the efficacy of olanzapine doses between treatment arms (e.g. 10 mg/day versus 40 mg/day ) in improving the psychopathology of schizophrenia as measured by mean changed from baseline on the PANSS total and subscores and Clinical Global
• Impression-Severity (CGI-S) Scale as well as by absolute score of CGI-I (Improvement) Scale
• To assess the efficacy of olanzapine doses as measured by efficacy scales in patients who have successfully completed the 2 week titration period
• To assess the efficacy of olanzapine doses within the standard range of 10 and 20 mg/day versus high dose 40 mg/day in improving the psychopathology of schizophrenia as measured by mean change from baseline on the PANSS total
• Vital signs and fasting laboratory analytes (clinical chemistry, hematology, lipid panel, and prolactin)
• To assess the response rate of olanzapine doses in improving the psychopathology of schizophrenia. Clinical response is defined as an improvement (reduction) of =>20% from baseline in the PANSS total score
• To compare the time to response among all olanzapine treatment arms. Clinical response is defined as an improvement (reduction) of =>20% from baseline in the PANSS total score. In addition, the cumulative frequency distribution of differential
• rates of response reduction in PANSS total score will be assessed at 8 weeks
• To compare the dose response efficacy between all olanzapine treatment arms in improving depressive symptoms as measured by a mean change from baseline on the Montgomery-Asberg Depression Rating Scale (MADRS)
• To assess the efficacy between all olanzapine treatment arms in improving patients' overall level of functioning and health-related quality of life as measured by the Global assessment of Functioning (GAF) and the Heinrich Carpenter
• Quality of Life Scale (QLS)
• To analyze steady-state olanzapine plasma concentrations following 10, 20, and 40 mg daily dosing and examine the associations between state plasma levels, efficacy, and safety measures
• To assess the safety between treatment arms and the safety dose-response relationship between the olanzapine treatment groups as determined by:
• Treatment-emergent adverse events,
• ECG
• Appetite as measured by the Eating Behavior Assessment
• Extrapyramidal symptoms as measured by the Modified Simpson-Angus Scale, The Barnes Akathisia Rating Scale, and the Abnormal Involuntary Movement Scale (AIMS)