Managing Acute Schizophrenia, a Comparison Between Two Atypical Antipsychotics

• Status: Completed
• Trial end date: 2003-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Antipsychotic Agents; Olanzapine; Risperidone

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