Managing Acute Schizophrenia, a Double Blind Comparison Between Two Atypical Antipsychotics - Olanzapine and Risperidone

Eli Lilly and Company1 site in 1 country122 target enrollmentApril 2003

ConditionsSchizophrenia

DrugsOlanzapine Hydrochloride Risperidone

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Schizophrenia
Sponsor: Eli Lilly and Company
Enrollment: 122
Locations: 1
Primary Endpoint: To determine if the efficacy of oral dose of olanzapine is greater than oral dose of risperidone in acute schizophrenia by comparing changes in agitation from baseline to 3 days post-first oral dose
Status: Completed
Last Updated: 18 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to examine whether olanzapine, compared to risperidone, can provide more adequate and timely control of behavioral agitation in acutely ill subjects with schizophrenia.

Registry

clinicaltrials.gov

Start Date

April 2003

End Date

December 2003

Last Updated

18 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Eli Lilly and Company

Eligibility Criteria

Inclusion Criteria

•Male or female subjects, aged 18 - 60
•Subjects must meet a clinical diagnosis of schizophrenia, schizophreniform disorder, or schizoaffective disorder according to DSM-IV
•Subjects' illness must not, in the opinion of the investigator, be caused by substance abuse
•BPRS total score (1 to 7 scale) of greater than or equal to 36 at visit 1
•Subjects must have a minimum total score of greater than or equal to 14 on the five items of the PANSS-EC and at least one individual item score of greater than or equal to 4 using the 1-7 scoring system prior to first dose of double-blind medications

Exclusion Criteria

•Treatment with antipsychotics or benzodiazepines within 4 hours prior to the first study drug administration
•Treatment with an injectable depot neuroleptic within 1 injection interval prior to study drug administration
•Electroconvulsive therapy (ECT) within 1 month (90 days) prior to study entry (visit 1)
•Treatment with remoxipride within 6 months (180 days) prior to visit 1
•Documented history of allergic reaction to study medications

Outcomes

Primary Outcomes

To determine if the efficacy of oral dose of olanzapine is greater than oral dose of risperidone in acute schizophrenia by comparing changes in agitation from baseline to 3 days post-first oral dose

Secondary Outcomes

To assess the efficacy of olanzapine compared with risperidone, in reduction of scores from baseline to 3 days as measured by the BPRS-T, PANSS-P, ACES, CGI-I and CGI-S.
To assess the efficacy of olanzapine compared with risperidone, in reduction of scores from baseline to 6 weeks of acute treatment in the BPRS-T
To assess the efficacy of olanzapine compared with risperidone, in reduction of scores from baseline to 6 weeks of acute treatment in the PANSS
To compare the change in severity of akathasia in schizophrenic patients between olanzapine and risperidone as measured by the BAS within the 6-week treatment period
To compare the change of severity of extrapyramidal symptoms within the 6 week treatment with olanzapine and risperidone, as measured by the SAS