Schizophrenia
Conditions
Keywords
KarXT, Cobenfy
Brief summary
The purpose of the study is to evaluate the relapse prevention of KarXT in the treatment of participants with Schizophrenia
Interventions
Specified dose on specified days
DRUGPlacebo
Specified dose on specified days
Sponsors
Karuna Therapeutics, Inc., a Bristol Myers Squibb company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Participant must have a primary diagnosis of schizophrenia for at least 1 year established by a comprehensive psychiatric evaluation based on the DSM-5-TR (American Psychiatric Association 2022) criteria and confirmed by MINI for Psychotic Disorder Studies version 7.0.2 at screening. * Participant must have experienced hospitalization for schizophrenia within 1 year from the screening date. * Participant must be experiencing residual schizophrenia symptoms and have a PANSS total score ≥70 to ≤ 110 at screening and Day -1. * Participant much have a PANSS Score of ≥ 4 (moderate or greater) on ≥ 2 of the following Positive Scale (P) items at screening and Day -1: 1. Item 1 (P1; delusions) 2. Item 2 (P2; conceptual disorganization) 3. Item 3 (P3; hallucinatory behavior) 4. Item 6 (P6; suspiciousness/persecution) * Participant must have a CGI-S score of ≥ 4 at screening and Day -1 * Participant must have a BMI ≥ 18 and ≤ 40 kg/m2.
Exclusion criteria
* Participant must not have any primary DSM-5 disorder other than schizophrenia within 12 months before screening * Participants must not have a newly diagnosed or are experiencing their first treated episode of psychosis or schizophrenia. * Participant must not have a risk of suicidal behavior as determined by the Investigator's clinical assessment and/or Columbia-suicide Severity Rating Scale (C-SSRS). * Participant must not have had psychiatric hospitalization(s) for more than 30 days (cumulative) within the 6 months before screening. * Participant must not have a history of treatment resistance to schizophrenia medications * Participant must not have decrease in PANSS total score (floor adjusted) between screening and Day -1 of more than 20%. * Other protocol-defined Inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time From Randomization to the First Relapse Event | Up to approximately Week 43 |
Secondary
| Measure | Time frame |
|---|---|
| Time to Discontinuation During Double-blind Treatment Period | Approximately From Week 18 to 43 |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Up to approximately Week 45 |
| Number of Participants With Adverse Events of Special Interest (AESIs) | Up to approximately Week 45 |
| Number of Participants With Procholinergic Symptoms | Up to approximately Week 45 |
| Number of Participants With Anticholinergic Symptoms | Up to approximately Week 45 |
| Number of Participants With Serious Adverse Events (SAEs) | Up to approximately Week 45 |
Countries
Argentina, Bulgaria, Czechia, Denmark, Poland, Romania, Spain, United Kingdom, 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