Schizophrenia
Conditions
Brief summary
The purpose of this study is to characterize the effect of KarXT on voiding dynamics and urological safety in participants with DSM-5 schizophrenia.
Interventions
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Male and Female participants (age 18 to 65 years of age, with a primary diagnosis of schizophrenia based on psychiatric evaluation (DSM-5) and confirmed by MINI (v 7.0.2). * Participants must have a PANSS total score ≤ 80 and CGI-S score ≤ 4, at screening and baseline, and a BMI ≥18 and ≤ 40 kg/m2. * Participants must be willing and able to discontinue all antipsychotic medications prior to the baseline visit and be willing and able to comply with protocol requirements.
Exclusion criteria
* Participants with newly diagnosed schizophrenia, any other DSM-5 disorder diagnosed within the past 12 months, alcohol or drug use disorder within the past 12 months, history/presence of clinically significant disease or disorder that would jeopardize participant safety or validity of study results. * Participants at risk for suicidal behavior, as well as individuals who are pregnant or breastfeeding, will be excluded from the study. * Other protocol-defined Inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in voiding dynamics (Qmax) over time | Up to 12 months |
| Change from baseline in post-void residual volume (PVR) over time | Up to 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Number of participants with a change from baseline in urinalysis parameters over time | Up to 12 months |
| Change from baseline in IPSS over time | Up to 12 months |
| Number of participants with electrocardiogram (ECG) abnormalities | Up to 12 months |
| Number of participants with vital sign abnormalities | Up to 12 months |
| Number of participants with Adverse Events (AEs) | Up to 12 months |
| Number of participants with AEs of Special Interest (AESIs) | Up to 12 months |
| Number of participants with Serious AEs (SAEs) | Up to 12 months |
| Number of participants with suicidal ideation or behavior | Up to 12 months |
Countries
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