New York State Psychiatric Institute
This is a single site clinical trial in which 12 participants with schizophrenia will be randomized to one of three doses of treatment with Cobenfy for 5 weeks. \[18F\]DOPA PET scans will be obtained before and after treatment to examine the effects of Cobenfy on dopamine transmission. The overall objective of the current study is to measure Cobenfy's ability to engage its putative target (DA transmission/synthesis capacity in the striatum and midbrain as measured by \[18F\]DOPA Kicer (\[18F\]DOPA relative uptake rate)).
Inclusion Criteria: 1. Individuals aged 18 to 50, inclusive at screen 2. Capable of understanding the study procedures and able to provide informed consent 3. Diagnosed with schizophrenia, schizoaffective, or schizophreniform disorder 4. Antipsychotic free at Visit 1 (by choice and for reasons unrelated to the study), and for at least 3 weeks (4 for aripiprazole, Cobenfy or LAIs) at the time of the baseline PET scan, inclusive of any antipsychotic-free time prior to consent 5. PANSS total score \> 80 and \< 120 6. Willing to use qualified methods of contraception (listed in section 5.3) for t…
Subjects will be randomized to 5 weeks of low, middle, or high dose of Xanomeline and trospium chloride, and will complete a PET scan with \[18\]F DOPA at the beginning and end of the treatment period.
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