Schizophrenia
Conditions
Brief summary
The purpose of the protocol is to evaluate the efficacy of olanzapine compared with Aripiprazole in patients with schizophrenia.
Interventions
DRUGOlanzapine
DRUGAripiprazole
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 65 Years
Healthy volunteers
No
Inclusion criteria
* Male or female inpatient or outpatients, ages 18-65
Exclusion criteria
* Participation in a clinical trial of another drug including olanzapine or aripiprazole within 30 days prior to study entry (visit 1). * Treatment with clozapine within the past 12 months. * Have known uncorrected narrow-angle glaucoma. * Have a diagnosis of Parkinson's disease, dementia or related disorder
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the long-term effectiveness and tolerability as measured by time to all-cause treatment discontinuation of olanzapine and aripiprazole relative to each other in patients with schizophrenia during 28 weeks of double-blind therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| improvement in psychopathology of schizophrenia as measured by PANSS change | — |
| change in CGI-S and PGI-I scores | — |
| level of activation as measured by PANSS change | — |
| depressive symptoms as measured by MADRS score | — |
| response rates | — |
| time to failure to maintain response | — |
| quality of life as measured by the SWN-S and SF-36 | — |
| To assess olanzapine versus aripiprazole in the following: | — |
| sexual functioning as measured by the GISF | — |
| health resource utilization and resource utilization costs | — |
| hospitalization time | — |
| treatment emergent adverse events | — |
| EPS as measured by the Simpson-Angus, Barnes, and AIMS | — |
| laboratory values | — |
| vital signs | — |
| cognitive functioning as measured by the MOS | — |
Countries
United States
Outcome results
None listed