Schizophrenia Trial of Aripiprazole

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)

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

Study Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Drug: Aripiprazole; Drug: Olanzapine or Quetiapine or Risperidone

• Study Type: Interventional
• Enrollment: 700
• Phase: Phase 3

Contacts and Locations

Study Locations

• Austria
  • Wien, Austria
    • Local Institution
• Czech Republic
  • Prerov, Czech Republic
    • Local Institution
• Denmark
  • Copenhagen, Denmark
    • Local Institution
  • Horsholm, Denmark
    • Local Institution
• Finland
  • Helsinki, Finland
    • Local Institution
• France
  • Brumath Cedex, France
    • Local Institution
  • Dole Cedex, France
    • Local Institution
  • Henin Beaumont Cedex, France
    • Local Institution
  • Jonzac Cedex, France
    • Local Institution
  • Nantes Orvault, France
    • Local Institution
  • Paris, France
    • Local Institution
  • Reims Cedex, France
    • Local Institution
  • Rennes, France
    • Local Institution
  • Toulouse, France
    • Local Institution
  • Uzes, France
    • Local Institution
• Germany
  • Duisburg, Germany
    • Local Institution
  • Hattingen, Germany
    • Local Institution
  • Muenchen, Germany
    • Local Institution
  • Nuernberg, Germany
    • Local Institution
  • Oldenburg, Germany
    • Local Institution
• Spain
  • Murcia, Spain
    • Local Institution
• Sweden
  • Bromma, Sweden
    • Local Institution
  • Gothenburgh, Sweden
    • Local Institution
  • Halmstad, Sweden
    • Local Institution
  • Malmo, Sweden
    • Local Institution
  • Sater, Sweden
    • Local Institution
• United Kingdom
  • Antrim
    • Belfast, Antrim, United Kingdom
      • Local Institution
  • Greater London
    • London, Greater London, United Kingdom
      • Local Institution
  • Kent
    • Tunbridge Wells, Kent, United Kingdom
      • Local Institution
  • Lanarkshire
    • Glasgow, Lanarkshire, United Kingdom
      • Local Institution
  • Lancashire
    • Davyhulme, Lancashire, United Kingdom
      • Local Institution
  • Mid Glamorgan
    • South Wales, Mid Glamorgan, United Kingdom
      • Local Institution
  • West Midlands
    • Birmingham, West Midlands, United Kingdom
      • Local Institution

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: A1	Drug: Aripiprazole; Tablets, Oral, 10 - 30 mg, Once daily, 26 weeks.; Other Names: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Score on the Investigator Assessment Questionnaire at week 26

Secondary Outcome Measures

Outcome Measure
Clinical Global Impression scale and patient preference of medication at endpoint

Collaborators and Investigators

• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
• Collaborators: Otsuka America Pharmaceutical
• Investigators: Principal Investigator: Bruno Millet, MD, Centre Hospitalier Guillaume Régnier, service de Psychiatrie adultes

Publications and helpful links

General Publications

• Hanssens L, L'Italien G, Loze JY, Marcus RN, Pans M, Kerselaers W. The effect of antipsychotic medication on sexual function and serum prolactin levels in community-treated schizophrenic patients: results from the Schizophrenia Trial of Aripiprazole (STAR) study (NCT00237913). BMC Psychiatry. 2008 Dec 22;8:95. doi: 10.1186/1471-244X-8-95.

Study record dates

Study Major Dates

• Study Start: July 1, 2004
• Primary Completion (Actual): August 1, 2005
• Study Completion (Actual): August 1, 2005

Study Registration Dates

• First Submitted: October 11, 2005
• First Submitted That Met QC Criteria: October 11, 2005
• First Posted (Estimate): October 13, 2005

Study Record Updates

• Last Update Posted (Estimate): November 8, 2013
• Last Update Submitted That Met QC Criteria: November 7, 2013
• Last Verified: July 1, 2008

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Dopamine Agonists; Dopamine Agents; Serotonin 5-HT1 Receptor Agonists; Serotonin Receptor Agonists; Serotonin 5-HT2 Receptor Antagonists; Serotonin Antagonists; Dopamine D2 Receptor Antagonists; Dopamine Antagonists; Olanzapine; Aripiprazole; Quetiapine Fumarate; Risperidone
• Other Study ID Numbers: CN138-152