Schizophrenia Trial of Aripiprazole - Full Text View

Sponsors and Collaborators:	Bristol-Myers Squibb Otsuka America Pharmaceutical
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00237913

Purpose

Aripiprazole will show improved effectiveness over the standard of care treatment with one of three atypical antipsychotics (olanzapine, quetiapine and risperidone).

Condition	Intervention	Phase
Schizophrenia	Drug: Aripiprazole Drug: Olanzapine or Quetiapine or Risperidone	Phase III

MedlinePlus related topics: Schizophrenia

Drug Information available for: Risperidone Quetiapine Quetiapine fumarate Olanzapine Aripiprazole

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Multicenter, Randomized, Naturalistic, Open-Label Study Between Aripiprazole and Standard of Care in the Management of Community-Treated Schizophrenic Patients (Schizophrenia Trial of Aripiprazole - STAR)

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

Score on the Investigator Assessment Questionnaire at week 26

Secondary Outcome Measures:

Clinical Global Impression scale and patient preference of medication at endpoint

Estimated Enrollment:	700
Study Start Date:	July 2004

Arms	Assigned Interventions
A1: Active Comparator	Drug: Aripiprazole Tablets, Oral, 10 - 30 mg, Once daily, 26 weeks.
B1: Active Comparator	Drug: Olanzapine or Quetiapine or Risperidone Olanzapine: Tablets, Oral, 5-20 mg, Once daily, 26 weeks. OR Quetiapine: Tablets, Oral, 100-800 mg, Once daily, 26 weeks. OR Risperidone: Tablets, Oral, 2-8 mg, Once daily, 26 weeks.

Eligibility

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

Criteria

Inclusion Criteria:

Clinical diagnosis of schizophrenia
Schizophrenia symptoms not optimally controlled or antipsychotic medication not well tolerated

Exclusion Criteria:

Diagnosis of schizoaffective disorder
Patients treatment-resistant to antipsychotics

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00237913

Show 36 Study Locations

Sponsors and Collaborators

Bristol-Myers Squibb

Otsuka America Pharmaceutical

Investigators

Principal Investigator:

Bruno Millet, MD

Centre Hospitalier Guillaume Régnier, service de Psychiatrie adultes

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:	CN138-152
Study First Received:	October 11, 2005
Last Updated:	July 24, 2008
ClinicalTrials.gov Identifier:	NCT00237913
Health Authority:	France: Afssaps-Agence Française de Sécurité Sanitaire des Produits de Santé

Study placed in the following topic categories:

Schizophrenia
Quetiapine
Dopamine
Mental Disorders
Risperidone

Olanzapine
Psychotic Disorders
Aripiprazole
Serotonin
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Gastrointestinal Agents
Psychotropic Drugs
Antiemetics
Central Nervous System Depressants
Dopamine Antagonists

Antipsychotic Agents
Serotonin Uptake Inhibitors
Pharmacologic Actions
Serotonin Antagonists
Serotonin Agents
Autonomic Agents
Therapeutic Uses
Dopamine Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009