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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
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Randomized Double-Blind Study of Olanzapine Versus Aripiprazole in the Treatment of Schizophrenia

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

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
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided by Eli Lilly and Company

Additional 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
Study First Received: July 19, 2004
Last Updated: July 16, 2007
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Olanzapine
Aripiprazole
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
 Therapeutic Uses
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on May 19, 2013