Study of Olanzapine vs. Aripiprazole in the Treatment of Schizophrenia
Phase 4
Completed
- Conditions
- Schizophrenia
- Registration Number
- NCT00088049
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
The purpose of the protocol is to evaluate the efficacy of olanzapine compared with Aripiprazole in patients with schizophrenia.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 560
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
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. test
🇺🇸Salt Lake City, Utah, United States