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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
450
Tablets, Oral, 15 mg fixed dose (week 1-5) flexible dose 10-30 mg (week 6-12), once daily, 12 weeks.
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.
Proportion of patients who discontinue because of Adverse Events
Time frame: Up to 22 months
Change in Clinical Global Impression scale, Investigator Assessment Questionnaire, cognitive functioning and outcome research assessments at endpoint
Time frame: Up to 22 months
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