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

Otsuka

Status and phase

Completed

Phase 3

Conditions

Schizophrenia

Treatments

Drug: Olanzapine

Drug: Aripiprazole

Study type

Interventional

Funder types

Industry

Identifiers

CN138-003

Details and patient eligibility

About

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

Enrollment

690 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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