Study Evaluating the Efficacy and Safety of WID-RGC20(Cariprazine) in Patients With Schizophrenia

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: WID-RGC20(Cariprazine) 3mg/day
* Drug: WID-RGC20(Cariprazine) 6mg/day
* Drug: Placebo for WID-RGC20(Cariprazine) 3mg/day or 6mg/day


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female patients 19 ≤ age < 65 years At least 1 year of schizophrenia diagnosed according to DSM-5 criteria(295.90) At least 1 psychotic episode within 1 year Current psychotic episode(acute exacerbation of schizophrenia) within 2 weeks 80 ≤ PANSS total score ≤ 120 Rating of at least 4(moderate) on at least 2 of the following 4 PANSS positive symptoms CGI-S score ≥ 4 Patients who can be hospitalized during the screening period and at least 3 weeks of the initial double-blind treatment phase Exclusion Criteria: Psychiatric Criteria Medical history except schizophrenia specified in protocol First-episode psychosis Treatment-resistant schizophrenia within 2 years Positive result from the blood alcohol concentration(BAC) test or the urine drug screen(UDS) Have suicide risk Treatment-related Criteria Electroconvulsive therapy(ECT) within 12 weeks or Previous lack of response to ECT Concomitant treatment with 3 or more antipsychotics within 12 weeks Treatment with flunitrazepam or LAI antipsychotics less than 1 cycle or clozapine within 24 weeks Treatment with CYP3A4 inducers or potent CYP3A4 inhibitors Treatment with amiodarone or systemic corticosteroids for ≥ 12 weeks within 1 year Required prohibited concomitant medication during the study period Prior participation in any clinical trials of Cariprazine Other Ophthalmic medical findings or related history(ex. uncontrolled diabetes or hypertension) Abnormal laboratory findings specified in protocol Not suitable for any other reason, as judged by the investigator

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cariprazine 3mg/day<br>WID-RGC20(Cariprazine) 3 mg/day | Drug: WID-RGC20(Cariprazine) 3mg/day<br>* 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).<br>|
| Experimental: Cariprazine 6mg/day<br>WID-RGC20(Cariprazine) 6 mg/day | Drug: WID-RGC20(Cariprazine) 6mg/day<br>* 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).<br>|
| Placebo Comparator: Placebo<br>Placebo for WID-RGC20(Cariprazine) 3 mg/day or 6mg/day | Drug: Placebo for WID-RGC20(Cariprazine) 3mg/day or 6mg/day<br>* The placebo comparator is administered during the double-blind treatment period(6 weeks).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive And Negative Syndrome Scale(PANSS) total score | Change from baseline in Positive And Negative Syndrome Scale(PANSS) total score at Week 6 | at Week 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Global Impressions-Severity(CGI-S) | Change from baseline in Clinical Global Impressions-Severity(CGI-S) at Week 6 | at Week 6 |