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

NCT03817502 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 330

Last updated 2025-10-08

No results posted yet for this study

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

Interventions

DRUG

Cariprazine

Cariprazine capsules, oral administration, once daily.

DRUG

Placebo

Matching placebo capsules, oral administration, once daily.

Sponsors & Collaborators

  • Gedeon Richter Plc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
13 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-06
Primary Completion
2026-12-15
Completion
2026-12-15
FDA Drug
Yes

Countries

  • United States
  • Bulgaria
  • Colombia
  • Mexico
  • Romania
  • Russia
  • Serbia
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT03817502 on ClinicalTrials.gov