NCT06589817

A Double-Blind, Randomized Comparative Study of Carliprazine and Aripiprazole in Patients with Acute Schizophrenia

A Phase 3, Multicenter, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of Hydrochloride Carliprazine Capsules or Aripiprazole Tablets for the Treatment of Acute Schizophrenia Subjects

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 376 (estimated)
• Sponsor: Chengdu Kanghong Pharmaceutical Group Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a non-Inferiority trial to evaluate efficacy and safety of hydrochloride carliprazine capsules and aripiprazole tablets in treating acute schizophrenia in Chinese adults. 376 patients will be randomizdely assigned in a 1:1 ratio to treatment group and control group. All enrolled subjects will be orally administered with hydrochloride carliprazine capsules or aripiprazole tablets for 6 consecutive weeks.

Conditions

• Acute Schizophrenia

Interventions

Type	Name	Description
DRUG	Hydrochloride Carliprazine capsules	Oral administration, once daily, with a total treatment duration of 6 weeks after successful screening.
DRUG	Aripiprazole tablets	Oral administration, once daily, with a total treatment duration of 6 weeks after successful screening.

Timeline

• Start date: 2024-10-01
• Primary completion: 2026-06-01
• Completion: 2026-12-01
• First posted: 2024-09-19
• Last updated: 2024-09-19