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Comparative Study of Aripiprazole and Olanzapine in the Treatment of Patients With Acute Schizophrenia | Clinical Trials | Clareo Health

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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

NCT00712686•Otsuka Pharmaceutical Development & Commercialization, Inc.

View on ClinicalTrials.gov

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

Age

18 - 65 years

Sex

ALL

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

Key Dates

Start Date

June 1, 2000

Primary Completion Date

December 1, 2003

Completion Date

December 1, 2003

Last Updated

November 8, 2013

Enrollment

690

ACTUAL participants

Conditions

Schizophrenia

Interventions

Aripiprazole

DRUG

Olanzapine

DRUG

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RECRUITING

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 8, 2013Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Feasibility, Acceptability, and Preliminary Efficacy of Yoga-based Group Intervention for Outpatients With Schizophrenia Spectrum Disorders

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