Study of Olanzapine vs. Aripiprazole in the Treatment of Schizophrenia

Eli Lilly and Company560 enrolled

Overview

The purpose of the protocol is to evaluate the efficacy of olanzapine compared with Aripiprazole in patients with schizophrenia.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

560

Conditions

Schizophrenia

Interventions

OlanzapineDRUG

AripiprazoleDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male or female inpatient or outpatients, ages 18-65 Exclusion Criteria: * Participation in a clinical trial of another drug including olanzapine or aripiprazole within 30 days prior to study entry (visit 1). * Treatment with clozapine within the past 12 months. * Have known uncorrected narrow-angle glaucoma. * Have a diagnosis of Parkinson's disease, dementia or related disorder

Locations (24)

Outcomes

Primary Outcomes

To determine the long-term effectiveness and tolerability as measured by time to all-cause treatment discontinuation of olanzapine and aripiprazole relative to each other in patients with schizophrenia during 28 weeks of double-blind therapy

Secondary Outcomes

To assess olanzapine versus aripiprazole in the following:

improvement in psychopathology of schizophrenia as measured by PANSS change

change in CGI-S and PGI-I scores

level of activation as measured by PANSS change

depressive symptoms as measured by MADRS score

response rates

time to failure to maintain response

quality of life as measured by the SWN-S and SF-36

cognitive functioning as measured by the MOS

sexual functioning as measured by the GISF

health resource utilization and resource utilization costs

hospitalization time

treatment emergent adverse events

EPS as measured by the Simpson-Angus, Barnes, and AIMS

laboratory values

Data from ClinicalTrials.gov

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For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. test

Little Rock, Arkansas, United States

Garden Grove, California, United States

National City, California, United States

Orange, California, United States

Fort Lauderdale, Florida, United States

Hollywood, Florida, United States

Tampa, Florida, United States

Atlanta, Georgia, United States

Chicago, Illinois, United States

Oakbrook Terrace, Illinois, United States

...and 14 more locations