To evaluate the efficacy, safety and tolerance of an 12 and 26-week aripiprazole administration
This trial was designed to evaluate the efficacy, safety and tolerance of an 12 and 26-week aripiprazole administration to schizophrenic outpatients who maintain stable (no change with dosage, usage, route of the most recent antipsychotic drugs) symptoms and discontinued previous antipsychotic drugs. Aripiprazole (10\~30 mg/day) will be orally administered for 12 weeks followed by an extension phase for a maximum of an additional 14 weeks (total of 26 weeks).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
500
Asan Medical Center
Seoul, South Korea
CGI-I mean score(at week 1, 3, 4, 8 & every 4 weeks until week 26)
Changes in PANSS total & PANSS subscore & depression subscore originated from PANSS (at week 4, 8 & every 4 weeks until week 26
IAQ (at week 8)
POM (at week 1, 2, 4, 8)
GAF (at week 8 & end of study)
CGI-S (at week 1, 3, 4, 8 & every 4 weeks until week 26)
AEs, Vital Signs, Weight gain, Prolactin increase, extrapyramidal syndrome, sleep disturbance, Laboratory tests (at week 1, 2, 4, 8 & every 4 weeks until week 26).
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