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

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-513194-44-00

Acronym

RGH-MD-20

Enrollment

Registered

2024-07-30

Start date

2021-12-14

Completion date

Unknown

Last updated

2026-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adolescent Patients (13 to 17 years of age) with Schizophrenia

Brief summary

Primary efficacy endpoint: Change from baseline to Week 6 on the PANSS total score

Detailed description

Comparison of AEs, clinical laboratory measures, vital signs, ECG, C-SSRS, CDSS, AIMS, BARS, SAS, UKU, menstrual cycle assessment, physical examination, and Tanner staging in cariprazine exposed participants versus placebo exposed participants

Interventions

DRUGReagila 1.5 mg hard capsules

DRUGFor the purpose of the clinical study a placebo formulation was prepared using the same white hard gelatine capsule shell.

DRUGReagila 3 mg hard capsules

DRUGCariprazine 0.5 mg capsules

DRUGhard

DRUGReagila 4.5 mg hard capsules

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
Primary efficacy endpoint: Change from baseline to Week 6 on the PANSS total score	—

Secondary

Measure	Time frame
Comparison of AEs, clinical laboratory measures, vital signs, ECG, C-SSRS, CDSS, AIMS, BARS, SAS, UKU, menstrual cycle assessment, physical examination, and Tanner staging in cariprazine exposed participants versus placebo exposed participants	—

Countries

Bulgaria, Romania

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026