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Taking peoplePhase 3

Tests cariprazine in teenagers with schizophrenia

Tests cariprazine against placebo in teenagers aged 13 to 17 with schizophrenia.

Key facts

Who runs it
Gedeon Richter Plc.
Where
Barranquilla, Bello, Bogotá, and Pereira, ColombiaSee the 5 sitesAlso in 7 other countries, 51 sites
Registry title
Efficacy and Safety of Cariprazine in the Treatment of Adolescent Participants (13 to 17 Years of Age) With Schizophrenia
Status
Recruiting
Phase
Phase 3
People taking part
330 people, planned
Started
6 Jun 2019
Expected to end
15 Dec 2026
Type of study
Interventional, 3 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • Cariprazine
  • Placebo
Record updated
8 October 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for teenagers aged 13 to 17 with schizophrenia who are moderately ill. It tests cariprazine against a placebo over 6 weeks.

Age
13 to 17 years
Sex
All sexes can join.
Disease stage
Schizophrenia confirmed by a trained clinician, with a PANSS score of 70 or more and a CGI-S score of 4 or more (moderately ill) at screening and baseline.

Main reasons for not taking part

  • Bipolar disorder, schizoaffective disorder, schizophreniform disorder, brief psychotic disorder, or psychotic disorder due to another medical condition
  • Intellectual disability (IQ < 70)
  • Any substance-related disorder (except caffeine and tobacco) in the 3 months before Visit 1

The registry criteria, word for word

Show all 7 criteriaShow less

Who can take part

  • DSM-5 primary diagnosis of schizophrenia
  • Schizophrenia diagnosis confirmed by the K-SADS-PL administered at screening (Visit 1) by a trained clinician
  • PANSS score ≥ 70 and a score of ≥ 4 (moderate) on 2 or more of the 5 items on the positive subscale of the PANSS (delusions, conceptual disorganization, hallucinatory behavior, grandiosity, suspiciousness/persecution), at screening (Visit 1) and baseline (Visit 2)
  • CGI-S scale score of ≥ 4 (moderately ill) at screening (Visit 1) and baseline (Visit 2)

Who cannot take part

  • Participant has a history of meeting DSM-5 diagnosis for any substance-related disorder (except caffeine- and tobacco-related) within the 3 months before Visit 1
  • Current diagnosis of bipolar disorder, schizoaffective disorder, schizophreniform disorder, brief psychotic disorder, or psychotic disorder due to another medical condition
  • Diagnosis of intellectual disability (IQ < 70)

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 13 and 17 years old?

Where in Colombia

Also in 7 other countries, 51 sites

  • Centro de Investigaciones y Proyectos en Nerurociencia. CIPNA. IPS. SAS.Barranquilla, ColombiaContact: Balázs LázárNo longer taking part
  • E.S.E. Hospital Mental de AntioquiaBello, ColombiaContact: Balázs LázárNo longer taking part
  • Centro de Investigacion del Sitema Nervioso CISNEBogotá, ColombiaContact: Balázs LázárNo longer taking part
  • Instituto Colombiano Sistema Nervioso Clinica MonserratBogotá, ColombiaContact: Balázs LázárNo longer taking part
  • Psynapsis Salud Mental SAPereira, ColombiaContact: Balázs LázárNo longer taking part

About the trial

What the trial wants to find out

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

The 3 groups in the trial

  • Cariprazine 1.5 mg/dTreatment being tested

    Cariprazine capsules, oral administration, once daily.

    Treatment: Cariprazine

  • Cariprazine 4.5 mg/dTreatment being tested

    Cariprazine capsules, oral administration, once daily.

    Treatment: Cariprazine

  • PlaceboPlacebo, for comparison

    Matching placebo capsules, oral administration, once daily.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
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
Plain-language title
Tests cariprazine in teenagers with schizophreniaGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT03817502, who can take part
Record updated
8 October 2025