Schizophrenia Trial of Aripiprazole

This study has been completed.
Otsuka America Pharmaceutical
Information provided by:
Otsuka Pharmaceutical Development & Commercialization, Inc. Identifier:
First received: October 11, 2005
Last updated: November 7, 2013
Last verified: July 2008
Aripiprazole will show improved effectiveness over the standard of care treatment with one of three atypical antipsychotics (olanzapine, quetiapine and risperidone).

Condition Intervention Phase
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:

Further study details as provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:

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.


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

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
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Please refer to this study by its identifier: NCT00237913

  Show 33 Study Locations
Sponsors and Collaborators
Otsuka Pharmaceutical Development & Commercialization, Inc.
Otsuka America Pharmaceutical
Principal Investigator: Bruno Millet, MD Centre Hospitalier Guillaume Régnier, service de Psychiatrie adultes
  More Information

Additional Information: Identifier: NCT00237913     History of Changes
Other Study ID Numbers: CN138-152 
Study First Received: October 11, 2005
Last Updated: November 7, 2013
Health Authority: France: Afssaps-Agence Française de Sécurité Sanitaire des Produits de Santé

Additional relevant MeSH terms:
Mental Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Antipsychotic Agents
Autonomic Agents
Central Nervous System Depressants
Dopamine Agents
Dopamine Antagonists
Gastrointestinal Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Peripheral Nervous System Agents
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Antagonists
Serotonin Uptake Inhibitors
Tranquilizing Agents processed this record on May 26, 2016