Status:
COMPLETED
Comparative Study of Aripiprazole and Olanzapine in the Treatment of Patients With Acute Schizophrenia
Lead Sponsor:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Conditions:
Schizophrenia
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
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
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2003
Estimated Enrollment :
690 Patients enrolled
Trial Details
Trial ID
NCT00712686
Start Date
June 1 2000
End Date
December 1 2003
Last Update
November 8 2013
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