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

• Status: Enrolling by invitation
• Trial end date: 2023-07-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Whanin Pharmaceutical Company
• Treatments: Cariprazine

Criteria

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