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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cariprazine 3mg/day | Experimental | WID-RGC20(Cariprazine) 3 mg/day |
|
| Cariprazine 6mg/day | Experimental | WID-RGC20(Cariprazine) 6 mg/day |
|
| Placebo | Placebo Comparator | Placebo for WID-RGC20(Cariprazine) 3 mg/day or 6mg/day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WID-RGC20(Cariprazine) 3mg/day | Drug | 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). |
| 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 |
| 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 |
| 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 1, 2, 3, 4, 5 | up to 5 weeks |
| Clinical Global Impressions-Severity(CGI-S) |
Inclusion Criteria:
Exclusion Criteria:
Psychiatric Criteria
Treatment-related Criteria
Other
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Whan In Pharm. | Seoul | South Korea |
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| WID-RGC20(Cariprazine) 6mg/day | Drug | 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). |
|
| Placebo for WID-RGC20(Cariprazine) 3mg/day or 6mg/day | Drug | The placebo comparator is administered during the double-blind treatment period(6 weeks). |
|
Change from baseline in Clinical Global Impressions-Severity(CGI-S) at Week 1, 2, 3, 4, 5
| up to 5 weeks |
| Clinical Global Impressions-Improvement(CGI-I) | Clinical Global Impressions-Improvement(CGI-I) at Week 1, 2, 3, 4, 5, 6 | up to 6 weeks |
| Positive And Negative Syndrome Scale(PANSS) positive score | Change from baseline in Positive And Negative Syndrome Scale(PANSS) positive score by Week 6 | up to 6 weeks |
| Positive And Negative Syndrome Scale(PANSS) negative score | Change from baseline in Positive And Negative Syndrome Scale(PANSS) negative score by Week 6 | up to 6 weeks |
| Positive And Negative Syndrome Scale(PANSS) responder | Percentage of subjects with at least 30% reduction in the Positive And Negative Syndrome Scale(PANSS) total score at Week 6 compared with baseline | at Week 6 |
| Adverse event(AE) | Incidence of Adverse event(AE)s by Week 8 | up to 8 weeks |
| Suicidal ideation and behavior | Incidence of suicidal ideation and behavior by Week 8 | up to 8 weeks |
| Extrapyramidal Symptoms(EPS) | Incidence of Extrapyramidal Symptoms(EPS) by Week 6 | up to 6 weeks |
| Laboratory test | Change from baseline in clinical laboratory tests by Week 6 | up to 6 weeks |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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