Status:
COMPLETED
A Switch Study of BMS-337039 in Schizophrenic Out-patients
Lead Sponsor:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborating Sponsors:
Otsuka America Pharmaceutical
Conditions:
Schizophrenia
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
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 tr...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2007
Estimated Enrollment :
450 Patients enrolled
Trial Details
Trial ID
NCT00232687
Start Date
June 1 2005
End Date
April 1 2007
Last Update
November 8 2013
Active Locations (72)
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1
Local Institution
Hall/Tirol, Austria
2
Local Institution
Vienna, Austria
3
Local Institution
Bruges, Belgium
4
Local Institution
Brussels, Belgium