NCT03817502

Efficacy and Safety of Cariprazine in the Treatment of Adolescent Participants (13 to 17 Years of Age) With Schizophrenia

A 6-week, International, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study of the Efficacy and Safety of Cariprazine in the Treatment of Adolescent Participants (13 to 17 Years of Age) With Schizophrenia

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 330 (estimated)
• Sponsor: Gedeon Richter Plc. · Industry
• Sex: All
• Age: 13 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of cariprazine in the treatment of schizophrenia in the adolescent population.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	Cariprazine	Cariprazine capsules, oral administration, once daily.
DRUG	Placebo	Matching placebo capsules, oral administration, once daily.

Timeline

• Start date: 2019-06-06
• Primary completion: 2026-12-15
• Completion: 2026-12-15
• First posted: 2019-01-25
• Last updated: 2025-10-08

Locations

57 sites across 8 countries: United States, Bulgaria, Colombia, Mexico, Romania, Russia, Serbia, Ukraine

Regulatory

• FDA-regulated drug study