Tests cariprazine in teenagers with schizophrenia
Tests cariprazine against placebo in teenagers aged 13 to 17 with schizophrenia.
Plain-language title generated from the registry record
Registry title: Efficacy and Safety of Cariprazine in the Treatment of Adolescent Participants (13 to 17 Years of Age) With Schizophrenia
Key facts
- Where
- Arkhangelsk, Kazan', Krasnodar, Lipetsk, Moscow, Nizhny Novgorod, Roshchino, Saint Petersburg, Samara, Saratov, Smolensk, Stavropol, Tomsk, Tonnel'nyy, and Yaroslavl Region, RussiaSee the 19 sites
- Phase
- Phase 3
Could this be for you?
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?
Source: NCT03817502, who can take part
Where in Russia
- State Institution of Healthcare "Arkhangelsk Regional Clinical Psychiatric Hospital"Arkhangelsk, RussiaNo longer taking part
- Kazan State Medical University KSMUKazan', RussiaNo longer taking part
- SBHI Specialized Clinical Psychiatric Hospital 1Krasnodar, RussiaNo longer taking part
- Regional Public Institution "Lipetsk Regional Psychoneurological Hospital"Lipetsk, RussiaNo longer taking part
- Joint-Stock Company Scientific Centre of Personalized MedicineMoscow, RussiaNo longer taking part
- SBHI of Moscow Region "Central Clinical Psychiatric Hospital"Moscow, RussiaNo longer taking part
- Clinical Psychiatry Hospital #1 of Nizhniy NovgorodNizhny Novgorod, RussiaNo longer taking part
- State Public Institution of Healthcare Leningrad Regional Psychoneurological DispensaryRoshchino, RussiaNo longer taking part
- Center for Medical Rehabilitation named after S.S. MnukhinSaint Petersburg, RussiaNo longer taking part
- City Psychiatric Hospital #3 after I.I. Skvortsova-StepanovaSaint Petersburg, RussiaNo longer taking part
- Federal State Budgetary Institution "National Medical Research Center of Psychiatry and Neurology n.a. V.M. Bekhterev" of the Ministry of Healthcare of the Russian FederationSaint Petersburg, RussiaNo longer taking part
- Saint-Petersburg GUZ Psychiatric Hospital No.1 n.a. P.P. KaschenkoSaint Petersburg, RussiaNo longer taking part
- GBUZ Samara Regional Clinical Psychiatric HospitalSamara, RussiaNo longer taking part
- State Budgetary Healthcare Institution "Saratov City Clinical Hospital #2 n.a. V.I. Razumovsky"Saratov, RussiaNo longer taking part
- Smolensk State Medical UniversitySmolensk, RussiaNo longer taking part
- LLC PodderzhkaStavropol, RussiaNo longer taking part
- LLC Clinic "Sto Let"Tomsk, RussiaNo longer taking part
- Stavropol Regional Psychiatric hospital #2Tonnel'nyy, RussiaNo longer taking part
- Yaroslavl Regional Psychiatric HospitalYaroslavl Region, RussiaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Gedeon Richter Plc.
- Trial code
- NCT03817502EU 2024-513194-44-00
- Record updated
- 8 October 2025
- Original description
The purpose of this study is to evaluate the efficacy and safety of cariprazine in the treatment of schizophrenia in the adolescent population.Read full original descriptionShow less
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
The purpose of this study is to evaluate the efficacy and safety of cariprazine in the treatment of schizophrenia in the adolescent population.
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: 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).