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

Phase 3

Completed

• Conditions: Schizophrenia
• Interventions: Drug: Aripiprazole; Drug: Olanzapine

• Registration Number: NCT00712686
• Lead Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

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 available

Study Timeline

• Study Start: 2000-06
• Primary Completion: 2003-12
• Study Completion: 2003-12
• Study First Submitted: 2008-07-08
• Study First Submitted QC: 2008-07-08
• Study First Posted: 2008-07-10
• Status Verified: 2010-06
• Last Update Submitted: 2013-11-07
• Last Update Posted: 2013-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 690

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A1	Aripiprazole	-
B1	Olanzapine	-

Primary Outcome Measures

Name	Time	Method
The mean change in the PANSS Total Score	from baseline to Week 6
The percentage of patients showing significant weight gain (a≥ 7% increase)	from baseline to Week 26

Secondary Outcome Measures

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