Managing Acute Schizophrenia, a Comparison Between Two Atypical Antipsychotics

Lilly

Status and phase

Completed

Phase 4

Conditions

Schizophrenia

Treatments

Drug: Risperidone

Drug: Olanzapine Hydrochloride

Study type

Interventional

Funder types

Industry

Identifiers

NCT00485498

6704

F1D-GH-S036

Details and patient eligibility

About

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.

Enrollment

122 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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