Managing Acute Schizophrenia, a Comparison Between Two Atypical Antipsychotics

Eli Lilly and Company122 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

122

Conditions

Schizophrenia

Interventions

Olanzapine HydrochlorideDRUG

RisperidoneDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (1)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Beijing, China

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

Data from ClinicalTrials.gov

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