A Phase 3 interventional study of Cariprazine and Placebo in Schizophrenia, sponsored by Gedeon Richter Plc.. Recruiting at 57 sites in 8 countries. Open to participants aged 13 Years to 17 Years. Per ClinicalTrials.gov, last updated 2025-10-08.
Sponsored by Gedeon Richter Plc. · Phase 3, Interventional, and Treatment
The purpose of this study is to evaluate the efficacy and safety of cariprazine in the treatment of schizophrenia in the adolescent population.
3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.
This study's planned enrollment of 330 is above the median of 70 across 2,872 interventional studies indexed under Schizophrenia.
Browse Schizophrenia studies →Gedeon Richter Plc. is the lead sponsor of 12 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Cariprazine capsules, oral administration, once daily.
Drug: Cariprazine
Cariprazine capsules, oral administration, once daily.
Drug: Cariprazine
Matching placebo capsules, oral administration, once daily.
Drug: Placebo
Cariprazine capsules, oral administration, once daily.
Matching placebo capsules, oral administration, once daily.
Change from baseline in PANSS total score at 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.
Time frame: Baseline to Week 6
Plan to share: Yes — Gedeon Richter will share de-identified patient-level data and study-level data for phase 2 - 4 trials completed after 2008 that are registered to ClinicalTrials.gov or EudraCT, have received regulatory approval in the United States and/or the European Union in a given indication and the primary manuscript from the trial has been published. To request access to the data, the researcher must sign a data use agreement and any shared data is to be used for non-commercial purposes. For more information please contact ra.ctarichter@richter.hu.
Supporting information: Study protocol, Csr
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Gedeon Richter Plc.