MedTrace Logo

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

NCT07423546 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2026-04-13

No results posted yet for this study

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

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.

Sponsors & Collaborators

Principal Investigators

  • Joshua T Kantrowitz, MD · New York State Psychiatric Institute

  • Ragy Girgis, MD · New York State Psychiatric Institute

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-01
Primary Completion
2027-04-30
Completion
2027-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07423546 on ClinicalTrials.gov