This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Study of Olanzapine vs. Aripiprazole in the Treatment of Schizophrenia

This study has been completed.
Information provided by:
Eli Lilly and Company Identifier:
First received: July 19, 2004
Last updated: July 16, 2007
Last verified: July 2007
The purpose of the protocol is to evaluate the efficacy of olanzapine compared with Aripiprazole in patients with schizophrenia.

Condition Intervention Phase
Schizophrenia Drug: Olanzapine Drug: Aripiprazole Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Randomized Double-Blind Study of Olanzapine Versus Aripiprazole in the Treatment of Schizophrenia

Resource links provided by NLM:

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • 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:
  • 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

Estimated Enrollment: 560
Study Start Date: October 2003
Study Completion Date: July 2007

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00088049

  Show 24 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
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
  More Information

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00088049     History of Changes
Other Study ID Numbers: 8047
Study First Received: July 19, 2004
Last Updated: July 16, 2007

Additional relevant MeSH terms:
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents processed this record on September 20, 2017