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

This study has been completed.
Sponsor:
Information provided by:
Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier:
NCT00712686
First received: July 8, 2008
Last updated: November 7, 2013
Last verified: June 2010
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
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 ClinicalTrials.gov identifier: 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
Study First Received: July 8, 2008
Last Updated: November 7, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Australia: Department of Health and Ageing Therapeutic Goods Administration

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

ClinicalTrials.gov processed this record on November 20, 2014