Aripiprazole for Schizophrenia Outpatients Completing BMS Clinical Trials

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators:	Bristol-Myers Squibb Otsuka America Pharmaceutical
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00239356

Purpose

The purpose of this study is to provide aripiprazole to schizophrenic outpatients and Community Treated Patients who are currently receiving aripiprazole therapy on another BMS sponsored clinical trial.

Condition	Intervention	Phase
Schizophrenia	Drug: Aripiprazole	Phase III

MedlinePlus related topics: Schizophrenia

Drug Information available for: Aripiprazole

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:	Aripiprazole (BMS-337039) for Outpatients With Schizophrenia Completing Aripiprazole Clinical Trials: A Non-Comparative Rollover Protocol

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

Clinical Global Impression [ Time Frame: Severity will be summarized over time ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety assessments [ Time Frame: throughout the study ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	400
Study Start Date:	March 2003
Estimated Study Completion Date:	November 2012
Estimated Primary Completion Date:	November 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
AI: Experimental	Drug: Aripiprazole Tablets, Oral, 10 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Currently receiving aripiprazole at time of screening
Men and women ages 18 to 70

Exclusion Criteria:

All patients previously discontinued from an aripiprazole study for any reason
Active alcohol or substance abuse
Patients who represent a significant risk of committing suicide
Patients with clinically significant abnormal laboratory test results, vital signs or ECG findings

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00239356

Locations

Canada, Ontario
Local Institution
Ottawa, Ontario, Canada
Canada, Quebec
Local Institution
Sherbrooke, Quebec, Canada
Croatia
Local Institution
Zagreb, Croatia
Local Institution
Zagreb, Croatia
Local Institution
Rijeka, Croatia
Czech Republic
Local Institution
Hradec Kralove, Czech Republic
Local Institution
Prague 6, Czech Republic
France
Local Institution
Rennes Cedex, France
Local Institution
Uzes, France
Local Institution
Nantes Orvault, France
Hungary
Local Institution
Budapest, Hungary
Local Institution
Gyor, Hungary
Netherlands
Local Institution
Vught, Netherlands
Poland
Local Institution
Krakow, Poland
Local Institution
Poznan, Poland
Romania
Local Institution
Bucharest, Romania
Russian Federation
Local Institution
St. Petersburg, Russian Federation
Local Institution
St. Petersburg, Russian Federation
South Africa, Free State
Local Institution
Westdene, Free State, South Africa
South Africa, Gauteng
Local Institution
Johannesburg, Gauteng, South Africa
South Africa, Western Cape
Local Institution
Cape Town, Western Cape, South Africa
United Kingdom
Local Institution
Antrim, United Kingdom

Sponsors and Collaborators

Bristol-Myers Squibb

Otsuka America Pharmaceutical

Investigators

Study Director:

Bristol-Myers Squibb

More Information

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

Responsible Party:	Bristol-Myers Squibb ( Study Director )
Study ID Numbers:	CN138-112
Study First Received:	October 13, 2005
Last Updated:	January 12, 2009
ClinicalTrials.gov Identifier:	NCT00239356
Health Authority:	France: Afssaps - French Health Products Safety Agency

Study placed in the following topic categories:

Schizophrenia
Mental Disorders
Psychotic Disorders
Aripiprazole
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:

Tranquilizing Agents
Therapeutic Uses
Physiological Effects of Drugs
Psychotropic Drugs

Central Nervous System Depressants
Antipsychotic Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009