NCT00088049
Completed
Phase 4
A Randomized Double-Blind Study of Olanzapine Versus Aripiprazole in the Treatment of Schizophrenia
ConditionsSchizophrenia
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Schizophrenia
- Sponsor
- Eli Lilly and Company
- Enrollment
- 560
- Locations
- 1
- Primary Endpoint
- 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
- Status
- Completed
- Last Updated
- 18 years ago
Overview
Brief Summary
The purpose of the protocol is to evaluate the efficacy of olanzapine compared with Aripiprazole in patients with schizophrenia.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
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 Outcomes
- To assess olanzapine versus aripiprazole in the following:
- 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
- cognitive functioning as measured by the MOS
- 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
Study Sites (1)
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