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

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

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

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: Aripiprazole
* Drug: Olanzapine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A1<br> | Drug: Aripiprazole<br>* Tablets, Oral, 15-30 mg, once daily, 140 weeks<br>* Other names: Abilify;|
| Active Comparator: B1<br> | Drug: Olanzapine<br>* Capsule, Oral, 10-20 mg, once daily, 140 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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-Positive Scale 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 | 
| Safety and tolerability |  | at the end of study |