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Comparative Study of Aripiprazole and Olanzapine in the Treatment of Patients With Acute Schizophrenia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00712686
First Posted: July 10, 2008
Last Update Posted: November 8, 2013
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.
Information provided by:
Otsuka Pharmaceutical Development & Commercialization, Inc.
  Purpose
The purpose of this study is to compare the efficacy and tolerability of aripiprazole to olanzapine over 26 weeks for the treatment of schizophrenia

Condition Intervention Phase
Schizophrenia Drug: Aripiprazole Drug: Olanzapine Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Double-Blind, Randomized, Comparative Study of Aripiprazole and Olanzapine in the Treatment of Patients With Acute Schizophrenia

Resource links provided by NLM:


Further study details as provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:

Primary Outcome Measures:
  • The mean change in the PANSS Total Score [ Time Frame: from baseline to Week 6 ]
  • The percentage of patients showing significant weight gain (a≥ 7% increase) [ Time Frame: from baseline to Week 26 ]

Secondary Outcome Measures:
  • Change from baseline on the CGI-S Score [ Time Frame: at the end of study ]
  • Change from baseline on PANSS Total Score [ Time Frame: at the end of study ]
  • Change from baseline on PANSS-Positive Scale Total Score [ Time Frame: at the end of study ]
  • Change from baseline on PANSS-Negative Scale Total Score [ Time Frame: at the end of study ]
  • Mean change from baseline in PANSS-derived Brief Psychiatric Rating Scale (BPRS) Core Score [ Time Frame: at the end of study ]
  • Mean CGI-I Score [ Time Frame: at the end of study ]
  • Percentage of responders (≥ 30% decrease in PANSS Total Score, or score of 1 or 2 on CGI-I) [ Time Frame: at the end of study ]
  • Change from baseline on the MADRS [ Time Frame: at the end of study ]
  • Safety and tolerability [ Time Frame: at the end of study ]

Enrollment: 690
Study Start Date: June 2000
Study Completion Date: December 2003
Primary Completion Date: December 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A1 Drug: Aripiprazole
Tablets, Oral, 15-30 mg, once daily, 140 weeks
Other Name: Abilify
Active Comparator: B1 Drug: Olanzapine
Capsule, Oral, 10-20 mg, once daily, 140 weeks

  Eligibility

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:

  • Patients with DSM-IV diagnosis of schizophrenia patients in acute relapse
  • Treated as outpatients for at least one continuous 3-month period during the past 12 months
  • PANSS total score ≥60
  • Previously responsive to neuroleptics (other than clozapine)
  • Able to give informed consent and comprehend and satisfactorily comply with the protocol requirements

Exclusion Criteria:

  • An Axis I (DSM-IV) diagnosis of schizoaffective disorder
  • A clinical picture and/or history that was consistent with: (a) Delirium, dementia, amnestic or other cognitive disorders; (b) Bipolar disorder; (c)personality disorder
  • Nonresponsive to prior olanzapine therapy
  • Likely to require prohibited concomitant therapy
  • DSM-IV criteria for any significant substance abuse within the past three months, including addiction to cocaine or alcohol
  • Known to be allergic or hypersensitive to study drugs
  • Represented a significant risk of committing suicide based on history or mental status exam
  • Unstable thyroid pathology and treatment within the past six months
  • A history or evidence of a medical condition that would expose the patient to an undue risk
  • Clinically significant abnormal laboratory test results (including urine drug screen), vital sign, or ECG findings
  Contacts and Locations
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): NCT00712686


Sponsors and Collaborators
Otsuka Pharmaceutical Development & Commercialization, Inc.
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
Publications:
Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00712686     History of Changes
Other Study ID Numbers: CN138-003
First Submitted: July 8, 2008
First Posted: July 10, 2008
Last Update Posted: November 8, 2013
Last Verified: June 2010

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