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Olanzapine Versus Aripiprazole in the Treatment of Acutely Ill Patients With Schizophrenia

NCT ID: NCT00103571

Last Updated: 2007-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-07-31

Study Completion Date

2006-08-31

Brief Summary

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The purposes of this study are to assess similarities and differences in the efficacy (how well the drug works), safety, and side effects of olanzapine and aripiprazole in patients with schizophrenia, schizoaffective disorder, or schizophreniform disorder.

Detailed Description

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Conditions

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Olanzapine

Intervention Type DRUG

Aripiprazole

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients must have schizophrenia, schizoaffective disorder, or schizophreniform disorder
* Patients must be agitated
* Patients must display psychotic symptoms
* Patients must be inpatients who are expected to stay in the hospital for at least 5 days
* Patients must be 18 to 55 years of age

Exclusion Criteria

* Patients may not be hospitalized for greater than 72 hours prior to study start
* Patients may not have received more than one dose of olanzapine or aripiprazole within 72 hours prior to study start
* Patients may not be actively suicidal
* Patients may not be diagnosed with substance-induced psychosis or substance dependence
* Patients may not have acute, serious, or unstable medical conditions
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Principal Investigators

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Call 1-877-CTLILLY(1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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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

Saint Charles, Missouri, United States

Site Status

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

Beachwood, Ohio, United States

Site Status

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

Canton, Ohio, United States

Site Status

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

Memphis, Tennessee, United States

Site Status

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

Rio Piedras, , Puerto Rico

Site Status

Countries

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United States Puerto Rico

Other Identifiers

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F1D-US-HGLS

Identifier Type: -

Identifier Source: secondary_id

8928

Identifier Type: -

Identifier Source: org_study_id