Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Comparative Study of Aripiprazole and Olanzapine in the Treatment of Patients With Acute Schizophrenia
This study has been completed.
Sponsored by: Bristol-Myers Squibb
Information provided by: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00712686
  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 III

MedlinePlus related topics: Schizophrenia
Drug Information available for: Olanzapine Aripiprazole
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A Multicenter, Double-Blind, Randomized, Comparative Study of Aripiprazole and Olanzapine in the Treatment of Patients With Acute Schizophrenia

Further study details as provided by Bristol-Myers Squibb:

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
A1: Active Comparator Drug: Aripiprazole
Tablets, Oral, 15-30 mg, once daily, 140 weeks
B1: Active Comparator 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00712686

Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

BMS Clinical Trials Disclosure  This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site

Responsible Party: Bristol-Myers Squibb ( Study Director )
Study ID Numbers: CN138-003
Study First Received: July 8, 2008
Last Updated: July 8, 2008
ClinicalTrials.gov Identifier: NCT00712686  
Health Authority: Germany: Federal Institute for Drugs and Medical Devices;   Australia: Department of Health and Ageing Therapeutic Goods Administration

Study placed in the following topic categories:
Schizophrenia
Mental Disorders
Olanzapine
Psychotic Disorders
 Aripiprazole
Serotonin
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Gastrointestinal Agents
Psychotropic Drugs
Antiemetics
Central Nervous System Depressants
 Antipsychotic Agents
Serotonin Uptake Inhibitors
Pharmacologic Actions
Serotonin Agents
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 14, 2009



U.S. National Library of Medicine,  Contact Help Desk
U.S. National Institutes of Health,  U.S. Department of Health & Human Services,
USA.gov,  Copyright,  Privacy,  Accessibility,  Freedom of Information Act

U.S. National Institutes of Health U.S. National Library of Medicine U.S. Department of Health & Human Services