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

NCT06589817 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 376

Last updated 2024-09-19

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Chengdu Kanghong Pharmaceutical Group Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-31
Primary Completion
2026-06-30
Completion
2026-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06589817 on ClinicalTrials.gov