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A Switch Study of BMS-337039 in Schizophrenic Out-patients

This study has been completed.
Otsuka America Pharmaceutical
Information provided by:
Otsuka Pharmaceutical Development & Commercialization, Inc. Identifier:
First received: October 3, 2005
Last updated: November 7, 2013
Last verified: February 2012
The purpose of this clinical research study is to evaluate the safety and tolerability of two switching strategies from risperidone to aripiprazole over a period of 12 weeks in out-patients who are treated in a general psychiatric practice setting and who are currently experiencing efficacy and/or safety/tolerability issues while on risperidone.

Condition Intervention Phase
Schizophrenia Drug: Aripiprazole Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Comparative, Randomized, Open-Label, Multicenter Study on the Efficacy and Safety of Switch Treatment With Aripiprazole in Schizophrenic Out-patients Who Are Experiencing Insufficient Efficacy With Risperidone and/or Safety and Tolerability Issues, While on Risperidone

Resource links provided by NLM:

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

Primary Outcome Measures:
  • Proportion of patients who discontinue because of Adverse Events

Secondary Outcome Measures:
  • Change in Clinical Global Impression scale, Investigator Assessment Questionnaire, cognitive functioning and outcome research assessments at endpoint

Enrollment: 450
Study Start Date: June 2005
Study Completion Date: April 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A1 Drug: Aripiprazole
Tablets, Oral, 15 mg fixed dose (week 1-5) flexible dose 10-30 mg (week 6-12), once daily, 12 weeks.
Other Name: Abilify
Active Comparator: A2 Drug: Aripiprazole
Tablets, Oral, Uptitration: 5 mg (week 1), 10 mg (week 2 and 3), 15 mg(week 4 and 5) flexible 10-30mg from week 6-12, once daily, 12 weeks.
Other Name: Abilify


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with a diagnosis of schizophrenia as defined by DSM-IV-TR2 criteria
  • Out-patients who have been taking Risperidone for minimum 6 weeks who are not optimally controlled and/or experiencing safety/tolerability issues with Risperidone
  • Men and women, aged 18 - 65 years

Exclusion Criteria:

  • Patients who are at risk for committing suicide
  • Patients with a diagnosis of schizoaffective disorder, bipolar disorder, depression with psychotic symptoms, or organic brain syndromes
  • Meeting DSM-IV-TR criteria for any significant Psychoactive Substance Use Disorder within the 3 months prior to Screening
  • Treatment-resistant to antipsychotic medication
  Contacts and Locations
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Please refer to this study by its identifier: NCT00232687

  Show 74 Study Locations
Sponsors and Collaborators
Otsuka Pharmaceutical Development & Commercialization, Inc.
Otsuka America Pharmaceutical
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
Publications: Identifier: NCT00232687     History of Changes
Other Study ID Numbers: CN138-169
Study First Received: October 3, 2005
Last Updated: November 7, 2013

Additional relevant MeSH terms:
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs processed this record on September 19, 2017