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Study of Olanzapine vs. Aripiprazole in the Treatment of Schizophrenia

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ClinicalTrials.gov Identifier: NCT00088049
Recruitment Status : Completed
First Posted : July 21, 2004
Last Update Posted : July 18, 2007
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Olanzapine Drug: Aripiprazole Phase 4

Study Type : Interventional  (Clinical Trial)
Enrollment : 560 participants
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
Study Start Date : October 2003
Actual Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources




Primary Outcome Measures :
  1. 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 :
  1. To assess olanzapine versus aripiprazole in the following:
  2. improvement in psychopathology of schizophrenia as measured by PANSS change
  3. change in CGI-S and PGI-I scores
  4. level of activation as measured by PANSS change
  5. depressive symptoms as measured by MADRS score
  6. response rates
  7. time to failure to maintain response
  8. quality of life as measured by the SWN-S and SF-36
  9. cognitive functioning as measured by the MOS
  10. sexual functioning as measured by the GISF
  11. health resource utilization and resource utilization costs
  12. hospitalization time
  13. treatment emergent adverse events
  14. EPS as measured by the Simpson-Angus, Barnes, and AIMS
  15. laboratory values
  16. vital signs


Information from the National Library of Medicine

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

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

Information from the National Library of Medicine

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): NCT00088049


  Show 24 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00088049     History of Changes
Other Study ID Numbers: 8047
F1D-MC-HGLB
First Posted: July 21, 2004    Key Record Dates
Last Update Posted: July 18, 2007
Last Verified: July 2007

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Aripiprazole
Olanzapine
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Antiemetics
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