A Study of Aripiprazole in the Management of Patients With Schizophrenia in the General Psychiatric Practices

NCT ID: NCT00237939

Last Updated: 2013-11-08

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

PHASE3

Total Enrollment

1200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-09-30

Study Completion Date

2006-11-30

Brief Summary

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The purpose of this clinical research study is to evaluate if Aripiprazole will prove to be effective, safe and well tolerated in the treatment of patients with schizophrenia who are treated in a general psychiatric setting.

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

NONE

Interventions

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Aripiprazole

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Clinical DSM-IV diagnosis of schizophrenia
* Patients being managed as outpatients, for whom an alteration in medication is clinically reasonable or initiation of antipsychotics is required

Exclusion Criteria

* Risk of committing suicide, diagnosis of schizoaffective disorder, bipolar disorder, depression with psychotic syptoms, or organic brain syndromes
* Prisoners or subjects compulsory detained
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Otsuka America Pharmaceutical

INDUSTRY

Sponsor Role collaborator

Otsuka Pharmaceutical Development & Commercialization, Inc.

INDUSTRY

Sponsor Role lead

Principal Investigators

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Hervé Allain, MD

Role: PRINCIPAL_INVESTIGATOR

Faculté de Médecine de Rennes I, laboratoire de pharmacologie

Locations

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Local Institution

Antwerp, , Belgium

Site Status

Local Institution

Brussels, , Belgium

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Diest, , Belgium

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Kortenberg, , Belgium

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Liège, , Belgium

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Sint-Michiels, , Belgium

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Sint-Niklaas, , Belgium

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Sint-Truiden, , Belgium

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Tournai, , Belgium

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Local Institution

Rennes, , France

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Local Institution

Amersfoort, , Netherlands

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Raalte, , Netherlands

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Rotterdam, , Netherlands

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Barcelos, , Portugal

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Ceira, , Portugal

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Coimbra, , Portugal

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Lisbon, , Portugal

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Barcelona, , Spain

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Salamanca, , Spain

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Seville, , Spain

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Countries

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Belgium France Netherlands Portugal Spain

Other Identifiers

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CN138-100

Identifier Type: -

Identifier Source: org_study_id