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

Whanin Pharmaceutical Company

Status and phase: Unknown; Phase 3

Conditions: Schizophrenia

Treatments: Drug: Placebo for WID-RGC20(Cariprazine) 3mg/day or 6mg/day; Drug: WID-RGC20(Cariprazine) 3mg/day; Drug: WID-RGC20(Cariprazine) 6mg/day

Study type: Interventional

Funder types: Industry

Identifiers

NCT05168007

WID-RGC20-P3

Details and patient eligibility

About

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.

Enrollment: 342 estimated patients

Sex: All

Ages: 19 to 64 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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342 participants in 3 patient groups, including a placebo group

Cariprazine 3mg/day

Experimental group

Description:

WID-RGC20(Cariprazine) 3 mg/day

Treatment:

Drug: WID-RGC20(Cariprazine) 3mg/day

Cariprazine 6mg/day

Experimental group

Description:

WID-RGC20(Cariprazine) 6 mg/day

Treatment:

Drug: WID-RGC20(Cariprazine) 6mg/day

Placebo

Placebo Comparator group

Description:

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

Treatment:

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