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

• Status: Completed
• Trial end date: 2003-12-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
• Treatments: Aripiprazole; Olanzapine

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