Study of Olanzapine vs. Aripiprazole in the Treatment of Schizophrenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00088049
Recruitment Status : Completed
First Posted : July 21, 2004
Last Update Posted : July 18, 2007
Information provided by:
Eli Lilly and Company

July 19, 2004
July 21, 2004
July 18, 2007
October 2003
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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
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Complete list of historical versions of study NCT00088049 on 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.
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Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
  • Drug: Olanzapine
  • Drug: Aripiprazole
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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July 2007
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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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
United States
Argentina,   Australia,   Brazil,   Chile,   Mexico,   Puerto Rico,   Venezuela
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Eli Lilly and Company
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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