KarXT compared with placebo for schizophrenia in teenagers
Tests KarXT against a placebo in adolescents with schizophrenia.
Plain-language title generated from the registry record
Registry title: A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Schizophrenia in Adolescents (EMERGENT TEEN)
Key facts
- Where
- Bucharest, Cluj-Napoca, Iasi, and Timișoara, RomaniaSee the 6 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: NCT07288567, who can take part
Where in Romania
- Cabinet Medical Individual Dr Gheorghita Karina LidiaBucharest, RomaniaTaking people
- Clinica AnimedicaBucharest, RomaniaTaking people
- Spitalul Clinic de Psihiatrie Prof Dr Alexandru ObregiaBucharest, RomaniaTaking people
- Spitalul Clinic de Urgenta pentru Copii Cluj NapocaCluj-Napoca, RomaniaTaking people
- Institutul De Psihiatrie Socola IasiIasi, RomaniaTaking people
- Spitalul Clinic de Urgenta pentru Copii Louis Turcanu TimisoaraTimișoara, RomaniaTaking people
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
- Bristol-Myers Squibb
- Trial code
- NCT07288567EU 2025-523711-11-00
- Record updated
- 6 October 2026
- Original description
The purpose of this study is to evaluate the efficacy and safety of KarXT for treatment of Schizophrenia in adolescents.Read full original descriptionShow less
A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Schizophrenia in Adolescents (13 to 17 Years of Age)
The purpose of this study is to evaluate the efficacy and safety of KarXT for treatment of Schizophrenia in adolescents.
Inclusion: Diagnosis of schizophrenia as defined by the The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition,Text Revision (DSM-5-TR) criteria, confirmed by the Kiddie Schedule for Affective Disorders and Schizophrenia-Present and Lifetime version (K-SADS-PL) and experiencing symptoms of psychosis at screening (Visit 1); PANSS total score of at least 70 at screening (Visit 1) and randomization (Visit 2); Participant has a CGI-S score of ≥ 4 at screening (Visit 1) and randomization (Visit 2).
Exclusion: Any primary DSM-5-TR disorder other than schizophrenia within 12 months before screening; History or presence of clinically significant cardiovascular, pulmonary, hepatic impairment, renal, hematologic, GI, endocrine, immunologic, dermatologic, neurologic, or oncologic disease or any other condition that, in the opinion of the investigator, would jeopardize the safety of the participant or the validity of the study results; All grades of hepatic impairment (mild [Child-Pugh Class A], moderate [Child-Pugh Class B], and severe [Child-Pugh Class C]). Participants with known intellectual disability defined as an IQ less than 70; or, either clinical evidence or known social or school history indicative of intellectual disability; Any neurological disorder, except for Tourette's Syndrome; Participants who have either a systolic blood pressure (sBP) or diastolic blood pressure (dBP) meeting criteria for stage 2 HTN, regardless of the presence or absence of symptoms; Other protocol-defined Inclusion/Exclusion criteria apply.