Cobenfy for Schizophrenia
What You Need to Know Before You Apply
What is the purpose of this trial?
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)).
Who Is on the Research Team?
Joshua T Kantrowitz, MD
Principal Investigator
New York State Psychiatric Institute
Ragy Girgis, MD
Principal Investigator
New York State Psychiatric Institute
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants are randomized to one of three doses of Cobenfy for 5 weeks, with PET scans before and after treatment to examine effects on dopamine transmission
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Cobenfy
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
5 weeks of xanomeline 50mg/trospium 20mg bid (low dose arm).
5 weeks of xanomeline 125mg/trospium 30mg bid (high dose arm).
5 weeks of xanomeline 100mg/trospium 20mg bid (middle dose arm).
Find a Clinic Near You
Who Is Running the Clinical Trial?
New York State Psychiatric Institute
Lead Sponsor
Bristol-Myers Squibb
Industry Sponsor
Christopher Boerner
Bristol-Myers Squibb
Chief Executive Officer since 2023
PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis
Deepak L. Bhatt
Bristol-Myers Squibb
Chief Medical Officer since 2024
MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania
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