NCT07423546

A PET/MRI Study of Cobenfy on Dopamine Transmission in Schizophrenia

A Multimodal PET/MRI Study of Cobenfy on Dopamine Transmission in Schizophrenia

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: New York State Psychiatric Institute · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

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)).

Conditions

• SCHIZOPHRENIA 1 (Disorder)
• Schizoaffecitve Disorder

Interventions

Type	Name	Description
DRUG	Xanomeline and trospium chloride (KarXT)	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.

Timeline

• Start date: 2026-07-01
• Primary completion: 2027-04-30
• Completion: 2027-12-31
• First posted: 2026-02-20
• Last updated: 2026-04-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study