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Cariprazine for Adolescent Schizophrenia

This study is testing a medication called cariprazine to see if it is safe and effective for teenagers (ages 13 to 17) who have schizophrenia. Schizophrenia is a mental health condition that affects how a person thinks, feels, and behaves. Participants will receive either cariprazine or a placebo (an inactive substance that looks like the study drug). The main goal is to see how much symptoms improve after 6 weeks, measured by a scale called PANSS. To join, you must have a diagnosis of schizophrenia confirmed by specific tests and have certain symptom scores. The current status of this study is unclear.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 330 participants.
What's involved
Participants will take either cariprazine or a matching placebo capsule by mouth once daily. The primary endpoint is measured at Week 6.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at Week 6, indicating follow-up for at least this duration.

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NCT03817502

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

Recruiting
PHASE3Ages 13–17InterventionalTreatment
Gedeon Richter Plc.
~330 participants
Updated 2025-10-08 on ClinicalTrials.gov
What's tested:CariprazinePlacebo

At a glance

Recruiting sites
4 of 57 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change from baseline in PANSS total score at Week 6
Measured over Baseline to Week 6

Conditions

Schizophrenia

Explore related trials

Schizophrenia

Where it's being run

57 sites across 14 states
Russia19
Mexico9
Ukraine8
Colombia5
Serbia3
Georgia2
New York2
Bulgaria2

Who to contact

Balázs Lázár
[email protected]
+36 1 432 6437
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Change from baseline in PANSS total score at Week 6Baseline to Week 6

    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 composite index, and general psychopathology. Each item is scored on a 7-point (1 to 7) scale, with 1 being minimal impact, and 7 being highest impact. The cumulative score ranges from 30 to 210. A negative change from baseline score indicates improvement.