Clinical trial NCT00485498: Managing Acute Schizophrenia, a Comparison Between Two Atypical Antipsychotics
Official title: Managing Acute Schizophrenia, a Double Blind Comparison Between Two Atypical Antipsychotics - Olanzapine and Risperidone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Schizophrenia
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2007-06-13
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: 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:
measure: 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.
measure: 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
measure: To assess the efficacy of olanzapine compared with risperidone, in reduction of scores from baseline to 6 weeks of acute treatment in the PANSS
measure: 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
measure: To compare the change of severity of extrapyramidal symptoms within the 6 week treatment with olanzapine and risperidone, as measured by the SAS
Other outcomes:
Locations:
city: Beijing
country: China
facility: 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.
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: