Effect on Cognitive Function of a Treatment With Aripiprazole

This study has been completed.

First Received: September 12, 2005 Last Updated: June 27, 2008 History of Changes

Sponsors and Collaborators:	Bristol-Myers Squibb Otsuka America Pharmaceutical
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00329810

Purpose

To evaluate the effectiveness of Aripiprazole after 12 weeks of therapy for Schizophrenic patients.

Condition	Intervention	Phase
Schizophrenia	Drug: Aripiprazole	Phase IV

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/Efficacy Study
Official Title:	A Prospective, Multicenter, Open-Label Study to Evaluate the Effectiveness and the Effect on Cognitive Function of a Treatment With Aripiprazole in a Board Range of Schizophrenic Patients

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

Clinical Global Impression scale at endpoint

Secondary Outcome Measures:

Change in Clinical Global Impression scale and cognition scales at endpoint

Estimated Enrollment:	500
Study Start Date:	March 2005

Arms	Assigned Interventions
Switch: Active Comparator	Drug: Aripiprazole Tablets, oral, 15 mg, once daily, 12 weeks.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosis of Schizophrenia
score of 2-6 in the CGI-S scale at basline
ambulatory or hospitalized subjects having symptoms which requires antipsychotic treatment

Exclusion Criteria:

women of child bearing potential
women pregnant or breast feeding
patients with a score of 0,-1 or 7
substance use

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00329810

Sponsors and Collaborators

Bristol-Myers Squibb

Otsuka America Pharmaceutical

Investigators

Principal Investigator:

Bristol-Myers Squibb

More Information

Additional 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

No publications provided

Study ID Numbers:	CN138-166
Study First Received:	September 12, 2005
Last Updated:	June 27, 2008
ClinicalTrials.gov Identifier:	NCT00329810 History of Changes
Health Authority:	Belgium: Institutional Review Board

Study placed in the following topic categories:

Schizophrenia
Tranquilizing Agents
Mental Disorders
Psychotropic Drugs
Central Nervous System Depressants

Psychotic Disorders
Aripiprazole
Antipsychotic Agents
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:

Schizophrenia
Tranquilizing Agents
Mental Disorders
Therapeutic Uses
Physiological Effects of Drugs
Psychotropic Drugs

Central Nervous System Depressants
Aripiprazole
Antipsychotic Agents
Central Nervous System Agents
Pharmacologic Actions
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on May 07, 2009