A Switch Study of BMS-337039 in Schizophrenic Out-Patients - Full Text View

Sponsors and Collaborators:	Bristol-Myers Squibb Otsuka America Pharmaceutical
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00232687

Purpose

The purpose of this clinical research study is to evaluate the safety and tolerability of two switching strategies from risperidone to aripiprazole over a period of 12 weeks in out-patients who are treated in a general psychiatric practice setting and who are currently experiencing efficacy and/or safety/tolerability issues while on risperidone.

Condition	Intervention	Phase
Schizophrenia	Drug: Aripiprazole	Phase IV

MedlinePlus related topics: Schizophrenia

Drug Information available for: Risperidone Aripiprazole

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Comparative, Randomized, Open-Label, Multicenter Study on the Efficacy and Safety of Switch Treatment With Aripiprazole in Schizophrenic Out-Patients Who Are Experiencing Insufficient Efficacy With Risperidone and/or Safety and Tolerability Issues, While on Risperidone

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

Proportion of patients who discontinue because of Adverse Events

Secondary Outcome Measures:

Change in Clinical Global Impression scale, Investigator Assessment Questionnaire, cognitive functioning and outcome research assessments at endpoint

Estimated Enrollment:	450
Study Start Date:	June 2005

Arms	Assigned Interventions
A1: Active Comparator	Drug: Aripiprazole Tablets, Oral, 15 mg fixed dose (week 1-5) flexible dose 10-30 mg (week 6-12), once daily, 12 weeks.
A2: Active Comparator	Drug: Aripiprazole Tablets, Oral, Uptitration: 5 mg (week 1), 10 mg (week 2 and 3), 15 mg(week 4 and 5) flexible 10-30mg from week 6-12, 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:

Patients with a diagnosis of schizophrenia as defined by DSM-IV-TR2 criteria
Out-patients who have been taking Risperidone for minimum 6 weeks who are not optimally controlled and/or experiencing safety/tolerability issues with Risperidone
Men and women, aged 18 - 65 years

Exclusion Criteria:

Patients who are at risk for committing suicide
Patients with a diagnosis of schizoaffective disorder, bipolar disorder, depression with psychotic symptoms, or organic brain syndromes
Meeting DSM-IV-TR criteria for any significant Psychoactive Substance Use Disorder within the 3 months prior to Screening
Treatment-resistant to antipsychotic medication

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00232687

Show 81 Study Locations

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

Study ID Numbers:	CN138-169
Study First Received:	October 3, 2005
Last Updated:	June 27, 2008
ClinicalTrials.gov Identifier:	NCT00232687
Health Authority:	Belgium: Service Public Fédéral Santé Publique, Sécurité de la Chaîne Alimentaire et Environnement

Study placed in the following topic categories:

Schizophrenia
Mental Disorders
Risperidone

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 16, 2009