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

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

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

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