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Schizophrenia Trial of Aripiprazole

This study has been completed.
Sponsor:
Collaborator:
Otsuka America Pharmaceutical
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00237913
First received: October 11, 2005
Last updated: April 7, 2011
Last verified: July 2008
History of Changes
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

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
Study Completion Date: August 2005
Primary Completion Date: August 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A1 Drug: Aripiprazole
Tablets, Oral, 10 - 30 mg, Once daily, 26 weeks.
Other Name: Abilify
Active Comparator: B1 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 33 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

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

ClinicalTrials.gov Identifier: NCT00237913     History of Changes
Other Study ID Numbers: CN138-152
Study First Received: October 11, 2005
Last Updated: April 7, 2011
Health Authority: France: Afssaps-Agence Française de Sécurité Sanitaire des Produits de Santé

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Risperidone
Quetiapine
Olanzapine
Aripiprazole
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antipsychotic Agents
 Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on June 17, 2013