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

This study has been completed.

Sponsor:

Information provided by:

Bristol-Myers Squibb

ClinicalTrials.gov Identifier:

NCT00712686

First received: July 8, 2008

Last updated: July 30, 2010

Last verified: June 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

July 8, 2008

Last Updated Date

July 30, 2010

Start Date ^ICMJE

June 2000

Primary Completion Date

December 2003 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00712686 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

A Multicenter, Double-Blind, Randomized, Comparative Study of Aripiprazole and Olanzapine in the Treatment of Patients With Acute Schizophrenia

Brief Summary

The purpose of this study is to compare the efficacy and tolerability of aripiprazole to olanzapine over 26 weeks for the treatment of schizophrenia

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Schizophrenia

Intervention ^ICMJE

Drug: Aripiprazole
Tablets, Oral, 15-30 mg, once daily, 140 weeks

Other Name: Abilify
Drug: Olanzapine
Capsule, Oral, 10-20 mg, once daily, 140 weeks

Study Arm (s)

Active Comparator: A1
Intervention: Drug: Aripiprazole
Active Comparator: B1
Intervention: Drug: Olanzapine

Publications *

Fleischhacker WW, McQuade RD, Marcus RN, Archibald D, Swanink R, Carson WH. A double-blind, randomized comparative study of aripiprazole and olanzapine in patients with schizophrenia. Biol Psychiatry. 2009 Mar 15;65(6):510-7. Epub 2008 Nov 4.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

690

Completion Date

December 2003

Primary Completion Date

December 2003 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00712686

Other Study ID Numbers ^ICMJE

CN138-003

Has Data Monitoring Committee

Responsible Party

Study Director, Bristol-Myers Squibb

Study Sponsor ^ICMJE

Bristol-Myers Squibb

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Bristol-Myers Squibb

Information Provided By

Bristol-Myers Squibb

Verification Date

June 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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