Schizophrenia
Conditions
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.
Interventions
DRUGRisperidone
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 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
China
Outcome results
None listed