Schizophrenia
Conditions
Brief summary
The purpose of this study is to evaluate the efficacy and safety of KarXT for treatment of Schizophrenia in adolescents.
Interventions
DRUGKarXT
Specified dose on specified days
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
13 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score | Week 5 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score | Week 5 | — |
| Change From Baseline in PANSS Positive Subscale Score | Week 5 | — |
| Change From Baseline in PANSS Negative Subscale Score | Week 5 | — |
| Change From Baseline in PANSS Marder Negative Factor Score | Week 5 | — |
| Number of Participants With PANSS Response | Week 5 | PANSS response will be determined by ≥ 30% reduction in PANSS total score. |
| Change From Baseline in Clinical Global Impression - Improvement (CGI-I) Score | Week 5 | — |
| Change From Baseline in Children's Global Assessment Scale (CGAS)) Score | Week 5 | — |
Countries
Colombia, Japan, Romania, United States
Contacts
CONTACTBMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACTFirst line of the email MUST contain NCT # and Site #.
STUDY_DIRECTORBristol-Myers Squibb
Bristol-Myers Squibb
Outcome results
None listed