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

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:	NCT00292409

Purpose

The purpose of this clinical research study is to evaluate the overall effectiveness of 8 week of aripiprazole treatment.

Condition	Intervention	Phase
Schizophrenia and Schizoaffective Disorder	Drug: Aripiprazole	Phase III

MedlinePlus related topics: Schizophrenia

Drug Information available for: Aripiprazole

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Prospective Open-Label Study of Aripiprazole in the Management of Patients With Schizophrenia in General Psychiatric Practices

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

Clinical Global Impression-Improvement at endpoint

Secondary Outcome Measures:

Clinical Global Impression scale
Investigator's Assessment Questionnaire
Patient preference of medication at endpoint

Estimated Enrollment:	400
Study Start Date:	March 2005
Study Completion Date:	February 2006

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 or schizoaffective disorder being treated as outpatients,no response to past antipsychotic treatment and patients who symptoms are notoptimally controlled defined as CGI- S<7

Exclusion Criteria:

pregnant or breastfeeding,patients at risk for committing suicide,diagnosis of mood disorders, delirium, dementia and other cognitive disorders,patients treatment resistant to otherantipyschotic medications and treatment with a long acting psychotic in which the last dose was within 3 months of treatment phase

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00292409

Sponsors and Collaborators

Bristol-Myers Squibb

Otsuka America Pharmaceutical

Investigators

Study Director:

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

Responsible Party:	Bristol-Myers Squibb ( Study Director )
Study ID Numbers:	CN138-125
Study First Received:	September 12, 2005
Last Updated:	June 27, 2008
ClinicalTrials.gov Identifier:	NCT00292409 History of Changes
Health Authority:	Czech Republic: State Institute for Drug Control

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:

Tranquilizing Agents
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Antipsychotic Agents
Pharmacologic Actions
Schizophrenia

Mental Disorders
Therapeutic Uses
Psychotic Disorders
Aripiprazole
Central Nervous System Agents
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on May 07, 2009