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NCT03817502 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Schizophrenia, sponsored by Gedeon Richter.

Recruiting
Registry status
Phase 3
Development phase
330
Enrollment target
20
Study locations

NCT03817502: Recruiting Phase 3 study of Schizophrenia, sponsored by Gedeon Richter.

NCT03817502 is a Phase 3 study of Schizophrenia that is actively recruiting participants, run by Gedeon Richter. The registered enrollment target is 330 participants, above the 218-participant average among 315 other Schizophrenia trials with a reported enrollment target (51% higher). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03817502, a Phase 3 study of Schizophrenia, is actively recruiting participants, sponsored by Gedeon Richter.

RECRUITING
Registry status
Phase 3
Development phase
330 participants
Enrollment target
20
Study locations

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.

Primary Outcome

The Positive and Negative Syndrome Scale is a 30-item rating scale specifically developed to asses both the positive and negative symptom syndromes of patients with schizophrenia. The PANSS total score is rated based on a structured clinical interview with the patient and supporting clinical information obtained from family, hospital staff, or other reliable informants. This assessment provides scores in 9 clinical domains, including a positive syndrome, a negative syndrome, depression, a compos

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG Cariprazine

Study Locations (20)

Other

  • Clinic of Child Psychiatry St. Nikolas - Sofia
  • MHAT Targovishte - Targovishte
  • Centro de Investigaciones y Proyectos en Nerurociencia. CIPNA. IPS. SAS. - Barranquilla
  • E.S.E. Hospital Mental de Antioquia - Bello
  • Centro de Investigacion del Sitema Nervioso CISNE - Bogotá
  • Instituto Colombiano Sistema Nervioso Clinica Monserrat - Bogotá
  • Psynapsis Salud Mental SA - Pereira
  • Centro para la Medicina y de Asistencia Medica Especializada S.C. - Culiacán
  • Instituto de Investigacion Clinica AC - Durango
  • Consultorio de Medicina Especializada del Sector Privado - Guadalajara
  • Consultorio Medico En Psiquiatria de Niños y Adolescentes Hospital Aranda de la Parra - Guanajuato City

Georgia

  • Atlanta Center for Medical Research - Atlanta
  • Atlanta Behavioral Research, LLC - Atlanta

New York

  • UB Department of Psychiatry - Buffalo
  • Manhattan Behavioral Medicine PLLC - New York

California

  • ProScience Research Group - Culver City

Michigan

  • Bloomfield Hills MI - Bloomfield Hills

Mississippi

  • Precise Research Centers - Flowood

Ohio

  • University of Cincinnati - Cincinnati

Texas

  • Family Psychiatry of The Woodlands - The Woodlands

Trial Details

FieldValue
Enrollment Target 330 participants
Start Date 2019-06-06
Est. Completion 2026-12-15
Phase Phase 3
Gedeon Richter

3 total trials

What NCT03817502 shows while recruiting

NCT03817502 is an interventional study that assigns participants to a tested intervention. The registered 330 participants enrollment target is mid-sized for trials with a published cap, above the 218-participant average among 315 other Schizophrenia trials with a reported enrollment target (51% higher).

The record links to 1 condition, with Schizophrenia appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT03817502 names 20 study sites across 8 states, led by Other, Georgia, New York.

Frequently Asked Questions

What is clinical trial NCT03817502 about?

NCT03817502 is a clinical study titled "Efficacy and Safety of Cariprazine in the Treatment of Adolescent Participants (13 to 17 Years of Age) With Schizophrenia". The purpose of this study is to evaluate the efficacy and safety of cariprazine in the treatment of schizophrenia in the adolescent population.

What is the current status of trial NCT03817502?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 330 participants. The study started on 2019-06-06. Estimated completion is 2026-12-15.

What conditions does trial NCT03817502 study?

This clinical trial studies the following conditions: Schizophrenia.

What interventions are being tested in trial NCT03817502?

The interventions under investigation include: Placebo (DRUG), Cariprazine (DRUG).

Who is sponsoring clinical trial NCT03817502?

This trial is sponsored by Gedeon Richter, which has 3 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03817502 being conducted?

This trial has 20 study locations across California, Georgia, Michigan, Mississippi, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Schizophrenia

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT03817502's enrollment target sits among peer trials

330 50th of 315 higher than 266 of 315 other Schizophrenia trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Schizophrenia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03817502, the US trial registry maintained by the National Library of Medicine. NCT03817502 (mid enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.