Study Evaluating the Efficacy and Safety of WID-RGC20(Cariprazine) in Patients With Schizophrenia
NCT ID: NCT05168007
Last Updated: 2021-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
342 participants
INTERVENTIONAL
2021-11-19
2023-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Cariprazine 3mg/day
WID-RGC20(Cariprazine) 3 mg/day
WID-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).
Cariprazine 6mg/day
WID-RGC20(Cariprazine) 6 mg/day
WID-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).
Placebo
Placebo for WID-RGC20(Cariprazine) 3 mg/day or 6mg/day
Placebo for WID-RGC20(Cariprazine) 3mg/day or 6mg/day
The placebo comparator is administered during the double-blind treatment period(6 weeks).
Interventions
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WID-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).
WID-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).
Placebo for WID-RGC20(Cariprazine) 3mg/day or 6mg/day
The placebo comparator is administered during the double-blind treatment period(6 weeks).
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
19 Years
64 Years
ALL
No
Sponsors
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Whanin Pharmaceutical Company
INDUSTRY
Responsible Party
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Locations
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Whan In Pharm.
Seoul, , South Korea
Countries
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Other Identifiers
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WID-RGC20-P3
Identifier Type: -
Identifier Source: org_study_id