2-year, Multicentre, Open-label, Flexible-dose Study to Evaluate the Safety and Tolerability of Cariprazine in the Treatment of Adolescent Patients with Schizophrenia

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-513222-30-00

Acronym

RGH-188-203

Enrollment

Registered

2024-07-16

Start date

2020-02-20

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 patient (13-17 years of age) with Schizophrenia

Brief summary

Primary Outcome Measures: adverse events, clinical laboratory assessments including HbA1c, prolactin, FSH and LH, menstrual cycle assessment, vital signs, weight, physical examination, ECG, C-SSRS, CDSS, AIMS, BARS, SAS, UKU and Tanner staging

Detailed description

"Additional Outcome Measures: Effectiveness measures: PANSS, CGI-S, CGI-I, C-GAS, CDR system Health-related outcome measures: CGSQ, PQ-LES-Q Per p Additional Outcome Measures: Effectiveness measures: PANSS, CGI-S, CGI-I, C-GAS, CDR system Health-related outcome measures: CGSQ, PQ-LES-Q Per p"

Interventions

DRUGCariprazine 0.5 mg capsules

DRUGhard

DRUGReagila 6 mg hard capsules

DRUGReagila 4.5 mg hard capsules

DRUGReagila 3 mg hard capsules

DRUGReagila 1.5 mg hard capsules

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
Primary Outcome Measures: adverse events, clinical laboratory assessments including HbA1c, prolactin, FSH and LH, menstrual cycle assessment, vital signs, weight, physical examination, ECG, C-SSRS, CDSS, AIMS, BARS, SAS, UKU and Tanner staging	—

Secondary

Measure	Time frame
"Additional Outcome Measures: Effectiveness measures: PANSS, CGI-S, CGI-I, C-GAS, CDR system Health-related outcome measures: CGSQ, PQ-LES-Q Per p Additional Outcome Measures: Effectiveness measures: PANSS, CGI-S, CGI-I, C-GAS, CDR system Health-related outcome measures: CGSQ, PQ-LES-Q Per p"	—

Countries

Bulgaria, Germany, Romania

Outcome results

None listed

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