Efficacy of High Dose Olanzapine for the Treatment of Schizophrenia and Schizoaffective Disorder

Eli Lilly and Company600 enrolled

Overview

The purposes of this study are to assess the efficacy, safety, and side effects among doses approved by the Food and Drug Administration and higher (not FDA approved) doses of olanzapine in patients with schizophrenia or schizoaffective disorder.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

600

Conditions

Schizophrenia Schizoaffective Disorder

Interventions

OlanzapineDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: * You must be 18 to 60 years old * You must have been diagnosed with schizophrenia or schizoaffective disorder * You must be able to visit the doctor's office 8 times over a 9 week period * You must agree to participate with all tests and examinations that are required for this study Exclusion Criteria: * You are a woman and are pregnant or breastfeeding * You presently have an acute or unstable medical illness * You have a history of an allergic reaction to olanzapine * You are taking medications that are not permitted in this study. Your physician will discuss these with you * You have taken part in another clinical research trial within the last 30 days or you have received treatment with a drug in the last 30 days that has not received regulatory approval.

Locations (33)

Outcomes

Primary Outcomes

The primary objective of this study is to assess the fixed dose response relationship for efficacy between standard and higher doses of olanzapine (10, 20, and 40 mg/day) in patients with schizophrenia or schizoaffective disorder.

Secondary Outcomes

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

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

Data from ClinicalTrials.gov

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