The purpose of this study is to compare the efficacy and tolerability of aripiprazole to olanzapine over 26 weeks for the treatment of schizophrenia
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
690
Tablets, Oral, 15-30 mg, once daily, 140 weeks
Capsule, Oral, 10-20 mg, once daily, 140 weeks
The mean change in the PANSS Total Score
Time frame: from baseline to Week 6
The percentage of patients showing significant weight gain (a≥ 7% increase)
Time frame: from baseline to Week 26
Change from baseline on the CGI-S Score
Time frame: at the end of study
Change from baseline on PANSS Total Score
Time frame: at the end of study
Change from baseline on PANSS-Positive Scale Total Score
Time frame: at the end of study
Change from baseline on PANSS-Negative Scale Total Score
Time frame: at the end of study
Mean change from baseline in PANSS-derived Brief Psychiatric Rating Scale (BPRS) Core Score
Time frame: at the end of study
Mean CGI-I Score
Time frame: at the end of study
Percentage of responders (≥ 30% decrease in PANSS Total Score, or score of 1 or 2 on CGI-I)
Time frame: at the end of study
Change from baseline on the MADRS
Time frame: at the end of study
Safety and tolerability
Time frame: at the end of study
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