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Evaluating cariprazine for treating schizophrenia in adolescents

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

PHASE3 · Gedeon Richter Plc. · NCT03817502

This study is testing if a medication called cariprazine can help teenagers aged 13 to 17 with schizophrenia feel better compared to a placebo.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment330 (estimated)
Ages13 Years to 17 Years
SexAll
SponsorGedeon Richter Plc. (industry)
Locations57 sites (Culver City, California and 56 other locations)
Trial IDNCT03817502 on ClinicalTrials.gov

What this trial studies

This study aims to assess the efficacy and safety of cariprazine in treating schizophrenia among adolescents aged 13 to 17. Participants will be diagnosed with schizophrenia based on DSM-5 criteria and will undergo evaluations using the K-SADS-PL and PANSS scales to confirm their condition. The study will compare the effects of cariprazine against a placebo to determine its effectiveness in alleviating symptoms of schizophrenia in this age group.

Who should consider this trial

Good fit: Ideal candidates are adolescents aged 13 to 17 with a confirmed diagnosis of schizophrenia and specific symptom severity as measured by PANSS and CGI-S scales.

Not a fit: Patients with bipolar disorder, schizoaffective disorder, or other specified psychotic disorders will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for managing schizophrenia in adolescents.

How similar studies have performed: Other studies have shown promising results with cariprazine in adult populations, but this specific adolescent application is relatively novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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).
* 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.

Where this trial is running

Culver City, California and 56 other locations

+7 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Schizophrenia

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.