This Study is a Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center, Fixed-Dose, Phase 3 Clinical Trial Evaluating the Efficacy and Safety of WID-RGC20 3 mg/day and 6 mg/day in Patients with Acute Psychotic Episode of Schizophrenia.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
342
The initial dose is WID-RGC20(Cariprazine) 1.5mg/day, followed by an up-titration of 1.5mg/day until the target dose(3mg/day) is achieved. The investigational product is administered during the double-blind treatment period(6 weeks).
The initial dose is WID-RGC20(Cariprazine) 1.5mg/day, followed by an up-titration of 1.5mg/day until the target dose(6mg/day) is achieved. The investigational product is administered during the double-blind treatment period(6 weeks).
The placebo comparator is administered during the double-blind treatment period(6 weeks).
Whan In Pharm.
Seoul, South Korea
Positive And Negative Syndrome Scale(PANSS) total score
Change from baseline in Positive And Negative Syndrome Scale(PANSS) total score at Week 6
Time frame: at Week 6
Clinical Global Impressions-Severity(CGI-S)
Change from baseline in Clinical Global Impressions-Severity(CGI-S) at Week 6
Time frame: at Week 6
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