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

Sponsor
Whanin Pharmaceutical Company
Study ID
NCT05168007
Phase
PHASE3
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
19 Years - 64 Years
Healthy Volunteers
Not accepted

Interventions

  • WID-RGC20(Cariprazine) 3mg/day — DRUG
    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 — DRUG
    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 — DRUG
    The placebo comparator is administered during the double-blind treatment period(6 weeks).

Study Details

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.

Key Dates

Start date
Nov 19, 2021
Status verified
Dec 2021
Primary completion
Jul 17, 2023
Completion
Jul 31, 2023

Study Design

Enrollment
342 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cariprazine 3mg/day
    WID-RGC20(Cariprazine) 3 mg/day
  • Experimental: Cariprazine 6mg/day
    WID-RGC20(Cariprazine) 6 mg/day
  • Placebo Comparator: Placebo
    Placebo for WID-RGC20(Cariprazine) 3 mg/day or 6mg/day

Primary Outcome Measure

Positive And Negative Syndrome Scale(PANSS) total score [ Time Frame: at Week 6 ]

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