NCT03817502 Efficacy and Safety of Cariprazine in the Treatment of Adolescent Participants (13 to 17 Years of Age) With Schizophrenia
| NCT ID | NCT03817502 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Gedeon Richter Plc. |
| Condition | Schizophrenia |
| Study Type | INTERVENTIONAL |
| Enrollment | 330 participants |
| Start Date | 2019-06-06 |
| Primary Completion | 2026-12-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 330 participants in total. It began in 2019-06-06 with a primary completion date of 2026-12-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of cariprazine in the treatment of schizophrenia in the adolescent population.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT03817502 clinical trial?
This trial is open to participants of all sexes, aged 13 Years or older, up to 17 Years, studying Schizophrenia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03817502 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 330 participants.
Is NCT03817502 currently recruiting?
Yes, NCT03817502 is actively recruiting participants. Contact the research team at RA.ctaRichter@richter.hu for enrollment information.
Where is the NCT03817502 trial being conducted?
This trial is being conducted at Culver City, United States, Atlanta, United States, Atlanta, United States, Bloomfield Hills, United States and 11 additional locations.
Who is sponsoring the NCT03817502 clinical trial?
NCT03817502 is sponsored by Gedeon Richter Plc.. The trial plans to enroll 330 participants.
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