Study of Olanzapine vs. Aripiprazole in the Treatment of Schizophrenia

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00088049
First received: July 19, 2004
Last updated: July 16, 2007
Last verified: July 2007

July 19, 2004
July 16, 2007
October 2003
Not Provided
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
Not Provided
Complete list of historical versions of study NCT00088049 on ClinicalTrials.gov Archive Site
  • 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
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Study of Olanzapine vs. Aripiprazole in the Treatment of Schizophrenia
A Randomized Double-Blind Study of Olanzapine Versus Aripiprazole in the Treatment of Schizophrenia

The purpose of the protocol is to evaluate the efficacy of olanzapine compared with Aripiprazole in patients with schizophrenia.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Schizophrenia
  • Drug: Olanzapine
  • Drug: Aripiprazole
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
560
July 2007
Not Provided

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00088049
8047, F1D-MC-HGLB
Not Provided
Not Provided
Eli Lilly and Company
Not Provided
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
Eli Lilly and Company
July 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP