Phase
Condition
Schizotypal Personality Disorder (Spd)
Affective Disorders
Tic Disorders
Treatment
KarXT
KarX-EC
Clinical Study ID
Ages 13-17 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
LAR (ie, legal guardian or caregiver) must have signed and dated an IRB/IEC-approvedICF in accordance with regulatory, local, and institutional guidelines.
Confirmed Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, TextRevision (DSM-5-TR) psychiatric diagnosis of 1 of the following:
Schizophrenia or schizoaffective disorder
Bipolar I or II disorder
Attention-deficit/hyperactivity disorder (ADHD)
Tourette's disorder
Autism spectrum disorder (ASD)
- Participant is judged by the investigator to be clinically stable (eg, nopsychiatric hospitalization within the last 6 months; no imminent risk of suicide orinjury to self, others, or property).
Exclusion
Exclusion Criteria:
Any clinically significant neurological, metabolic (including type 1 diabetes),hepatic, renal, hematological, pulmonary, cardiovascular, GI (including activeobstructive GI disorders), carcinoma, active biliary disorders (eg, symptomaticgallstones) and/or urological disorder, congestive heart failure (uncontrolled), orCNS infection that would pose a risk to the participants if they were to participatein the study or that might confound the results of the study.
Participant has a risk for suicidal behavior during the study, as determined by theinvestigator's clinical judgment and C-SSRS.
eGFR < 60 mL/min.
History of Gilbert's Disease or history of liver disease (Child-Pugh class A andhigher).
History or high risk of urinary retention, gastric retention, or narrow-angleglaucoma.
Participants with history of bladder stones or recurrent UTIs.
Other protocol defined inclusion/exclusion criteria apply.
Study Design
Connect with a study center
Local Institution - 0005
Little Rock, Arkansas 72204
United StatesSite Not Available
Pillar Clinical Research- Little Rock
Little Rock, Arkansas 72204
United StatesActive - Recruiting
Local Institution - 0006
Orange, California 92868
United StatesSite Not Available
NRC Research Institute
Orange, California 92868
United StatesActive - Recruiting
CenExel iResearch, LLC
Decatur, Georgia 30030
United StatesActive - Recruiting
Local Institution - 0007
Decatur, Georgia 30030
United StatesSite Not Available
Dr. Vince Clinical Research
Overland Park, Kansas 66212
United StatesActive - Recruiting
Local Institution - 0008
Overland Park, Kansas 66212
United StatesSite Not Available
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