Schizophrenia
Conditions
Brief summary
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.
Interventions
DRUGWID-RGC20(Cariprazine) 3mg/day
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).
DRUGWID-RGC20(Cariprazine) 6mg/day
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).
DRUGPlacebo for WID-RGC20(Cariprazine) 3mg/day or 6mg/day
The placebo comparator is administered during the double-blind treatment period(6 weeks).
Sponsors
Whanin Pharmaceutical Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to 64 Years
Healthy volunteers
No
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
1. 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 2. 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 3. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Positive And Negative Syndrome Scale(PANSS) total score | at Week 6 | Change from baseline in Positive And Negative Syndrome Scale(PANSS) total score at Week 6 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Global Impressions-Severity(CGI-S) | at Week 6 | Change from baseline in Clinical Global Impressions-Severity(CGI-S) at Week 6 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Clinical Global Impressions-Improvement(CGI-I) | up to 6 weeks | Clinical Global Impressions-Improvement(CGI-I) at Week 1, 2, 3, 4, 5, 6 |
| Positive And Negative Syndrome Scale(PANSS) positive score | up to 6 weeks | Change from baseline in Positive And Negative Syndrome Scale(PANSS) positive score by Week 6 |
| Positive And Negative Syndrome Scale(PANSS) negative score | up to 6 weeks | Change from baseline in Positive And Negative Syndrome Scale(PANSS) negative score by Week 6 |
| Positive And Negative Syndrome Scale(PANSS) responder | at Week 6 | Percentage of subjects with at least 30% reduction in the Positive And Negative Syndrome Scale(PANSS) total score at Week 6 compared with baseline |
| Positive And Negative Syndrome Scale(PANSS) total score | up to 5 weeks | Change from baseline in Positive And Negative Syndrome Scale(PANSS) total score at Week 1, 2, 3, 4, 5 |
| Suicidal ideation and behavior | up to 8 weeks | Incidence of suicidal ideation and behavior by Week 8 |
| Extrapyramidal Symptoms(EPS) | up to 6 weeks | Incidence of Extrapyramidal Symptoms(EPS) by Week 6 |
| Laboratory test | up to 6 weeks | Change from baseline in clinical laboratory tests by Week 6 |
| Adverse event(AE) | up to 8 weeks | Incidence of Adverse event(AE)s by Week 8 |
| Clinical Global Impressions-Severity(CGI-S) | up to 5 weeks | Change from baseline in Clinical Global Impressions-Severity(CGI-S) at Week 1, 2, 3, 4, 5 |
Countries
South Korea
Outcome results
None listed