NCT00232687

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 450 (actual)
• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	Aripiprazole	Tablets, Oral, 15 mg fixed dose (week 1-5) flexible dose 10-30 mg (week 6-12), once daily, 12 weeks.
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.

Timeline

• Start date: 2005-06-01
• Primary completion: 2007-04-01
• Completion: 2007-04-01
• First posted: 2005-10-05
• Last updated: 2013-11-08

Locations

72 sites across 10 countries: Austria, Belgium, Czechia, France, Germany, Greece, Hungary, Italy, Spain, United Kingdom