The study design is a de-escalation of current atypical AP treatment to X/T at a maintenance dose of X/T established either at 100 mg xanomeline/20 mg trospium chloride BID (total daily dose 200 mg xanomeline/40 mg trospium chloride) or 125 mg xanomeline/30 mg trospium chloride BID (total daily dose 250 mg xanomeline/60 mg trospium chloride) based on participants' clinical response and/or tolerability. While the package insert for X/T provides guidance for clinicians on dosing, this study is designed to assess how transitioning will occur in the "real world" situation.
Participant is aged 18 to 65 years, inclusive, at Screening.
Participant is capable of providing informed consent.
A signed informed consent form (ICF) must be provided before any study assessments are performed.
Participant must be fluent in English (oral and written) as the language of the ICF to consent. No translations will be permitted.
Any primary DSM-5 disorder other than schizophrenia within 6 months before Screening (confirmed using MINI version 7.0.2 at Screening). Exclusionary disorders include, but are not limited to, major depressive disorder, bipolar I or II disorder, schizoaffective disorder, obsessive compulsive disorder, and posttraumatic stress disorder. Symptoms of mild mood dysphoria or anxiety are allowed as long as these symptoms are not the primary focus of treatment.
Participant has a history of moderate to severe alcohol use disorder or a substance (other than nicotine or caffeine) use disorder within the past 6 months or a positive urine drug screen (UDS) for a substance other than cannabis at Screening or Baseline.
Participants with mild substance use disorder within the 6 months before Screening must be discussed and agreed upon with the Principal Investigator (PI) before they can be allowed into the study.
Participants with positive UDS for cannabis are permitted to enroll in the study provided that the participants' pattern of use is not indicative of a substance use disorder.
Collaborative Neuroscience Research, LLC
Lead sponsor
Bristol-Myers Squibb
Collaborator