Clinical trial NCT05168007: Study Evaluating the Efficacy and Safety of WID-RGC20(Cariprazine) in Patients With Schizophrenia
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Schizophrenia
Lead sponsor: Whanin Pharmaceutical Company
Sponsor class: INDUSTRY
First posted: 2021-12-22
Enrollment: 342
Sex: ALL
Minimum age (years): 19
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Positive And Negative Syndrome Scale(PANSS) total score
timeFrame: at Week 6
Secondary outcomes:
measure: Clinical Global Impressions-Severity(CGI-S)
timeFrame: at Week 6
Other outcomes:
measure: Positive And Negative Syndrome Scale(PANSS) total score
timeFrame: up to 5 weeks
measure: Clinical Global Impressions-Severity(CGI-S)
timeFrame: up to 5 weeks
measure: Clinical Global Impressions-Improvement(CGI-I)
timeFrame: up to 6 weeks
measure: Positive And Negative Syndrome Scale(PANSS) positive score
timeFrame: up to 6 weeks
measure: Positive And Negative Syndrome Scale(PANSS) negative score
timeFrame: up to 6 weeks
measure: Positive And Negative Syndrome Scale(PANSS) responder
timeFrame: at Week 6
measure: Adverse event(AE)
timeFrame: up to 8 weeks
measure: Suicidal ideation and behavior
timeFrame: up to 8 weeks
measure: Extrapyramidal Symptoms(EPS)
timeFrame: up to 6 weeks
measure: Laboratory test
timeFrame: up to 6 weeks
Locations:
city: Seoul
country: Korea, Republic of
facility: Whan In Pharm.
Study officials:
References: