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

Phase 3

• Conditions: Schizophrenia
• Interventions: Drug: Placebo for WID-RGC20(Cariprazine) 3mg/day or 6mg/day; Drug: WID-RGC20(Cariprazine) 3mg/day; Drug: WID-RGC20(Cariprazine) 6mg/day

• Registration Number: NCT05168007
• Lead Sponsor: Whanin Pharmaceutical Company

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-11-19
• Study First Submitted: 2021-11-26
• Status Verified: 2021-12
• Study First Submitted QC: 2021-12-08
• Last Update Submitted: 2021-12-08
• Study First Posted: 2021-12-22
• Last Update Posted: 2021-12-22
• Primary Completion: 2023-07-17
• Study Completion: 2023-07-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 342

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo for WID-RGC20(Cariprazine) 3mg/day or 6mg/day	Placebo for WID-RGC20(Cariprazine) 3 mg/day or 6mg/day
Cariprazine 3mg/day	WID-RGC20(Cariprazine) 3mg/day	WID-RGC20(Cariprazine) 3 mg/day
Cariprazine 6mg/day	WID-RGC20(Cariprazine) 6mg/day	WID-RGC20(Cariprazine) 6 mg/day

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Clinical Global Impressions-Severity(CGI-S)	at Week 6	Change from baseline in Clinical Global Impressions-Severity(CGI-S) at Week 6

Trial Locations

Locations (1)

Whan In Pharm.; 🇰🇷 Seoul, Korea, Republic of