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

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: NCT00232687
Recruitment Status : Completed
First Posted : October 5, 2005
Last Update Posted : November 8, 2013
Otsuka America Pharmaceutical
Information provided by:
Otsuka Pharmaceutical Development & Commercialization, Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
Schizophrenia Drug: Aripiprazole Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 450 participants
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
Study Start Date : June 2005
Actual Primary Completion Date : April 2007
Actual Study Completion Date : April 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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

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

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

Information from the National Library of Medicine

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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

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): NCT00232687

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Sponsors and Collaborators
Otsuka Pharmaceutical Development & Commercialization, Inc.
Otsuka America Pharmaceutical
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
Publications: Identifier: NCT00232687     History of Changes
Other Study ID Numbers: CN138-169
First Posted: October 5, 2005    Key Record Dates
Last Update Posted: November 8, 2013
Last Verified: February 2012

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