Schizophrenia Trial of Aripiprazole

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00237913
Recruitment Status : Completed
First Posted : October 13, 2005
Last Update Posted : November 8, 2013
Otsuka America Pharmaceutical
Information provided by:
Otsuka Pharmaceutical Development & Commercialization, Inc.

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

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Aripiprazole Drug: Olanzapine or Quetiapine or Risperidone Phase 3

Study Type : Interventional  (Clinical Trial)
Enrollment : 700 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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)
Study Start Date : July 2004
Actual Primary Completion Date : August 2005
Actual Study Completion Date : August 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Score on the Investigator Assessment Questionnaire at week 26

Secondary Outcome Measures :
  1. Clinical Global Impression scale and patient preference of medication at endpoint

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00237913     History of Changes
Other Study ID Numbers: CN138-152
First Posted: October 13, 2005    Key Record Dates
Last Update Posted: November 8, 2013
Last Verified: July 2008

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