The purpose of this study is to evaluate the effect on patient weight of adjunctive therapy of aripiprazole with clozapine versus clozapine monotherapy, in schizophrenic patients who are not optimally controlled on clozapine.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
200
Tablets, Oral, 5 mg, 10 mg, 15 mg, once daily, 16 weeks followed by 12 weeks of Open-Label extension phase (optional).
Tablets, Oral, 0 mg, once daily, 16 weeks followed by 12 weeks of Open-Label extension phase (optional)
Evaluate effect on patient weight of adjunctive therapy of aripiprazole with clozapine versus clozapine mono-therapy in schizophrenic patients who are not optimally controlled on clozapine.
The mean change from baseline in patient weight at Week 16 (LOCF) will be compared between the 2 groups.
Efficacy (PANSS, CGI)
Effectiveness (IAQ, GAF)
Patient Reported Outcomes
Safety
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