Olanzapine Versus Placebo in the Treatment of Adolescents With Schizophrenia
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|ClinicalTrials.gov Identifier: NCT00051298|
Recruitment Status : Completed
First Posted : January 9, 2003
Last Update Posted : June 12, 2007
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia||Drug: Olanzapine Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||107 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Olanzapine Versus Placebo in the Treatment of Adolescents With Schizophrenia|
|Study Start Date :||November 2002|
|Actual Study Completion Date :||April 2005|
- Assess the efficacy of a flexible dose of olanzapine compared to placebo in the treatment of adolescents (ages 13 - 17) with schizophrenia using the BPRS-C
- Assess secondary efficacy measures to capture additional evidence of efficacy utilizing the CGI-I, CGI-S, PANSS and OAS
- Assess the efficacy of olanzapine compared with placebo in improving clinical symptomatology in terms of rate of response
- Assess the safety of olanzapine compared with placebo for up to 6 weeks of double-blind treatment and for up to an additional 26 weeks of open-label olanzapine treatment.
- Assess the health-related quality of life and cognition associated with olanzapine compared with placebo for up to 6 weeks of double-blind treatment and for up to an additional 26 weeks of open-label olanzapine treatment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00051298
Show 25 Study Locations
|Study Director:||Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)||Eli Lilly and Company|