A PET/MRI Study of Cobenfy on Dopamine Transmission in Schizophrenia
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-50
SponsorNew York State Psychiatric Institute
About 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)).
Eligibility criteria
Qualifiers
Individuals aged 18 to 50, inclusive at screen
Capable of understanding the study procedures and able to provide informed consent
Diagnosed with schizophrenia, schizoaffective, or schizophreniform disorder
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
Disqualifiers
Diagnosis of moderate or severe substance use disorder within the previous month (from first PET scan)
A history of poor or inadequate response to Cobenfy for any reason, hypersensitivity to Cobenfy or trospium or no justifiable reason to expect improvement on Cobenfy, or treatment with Cobenfy within 4 weeks of the first PET Scan
EKG abnormality that is clinically significant including a QT interval > 450 msec for men and > 470 msec for women, as corrected by the Fridericia formula (QTcF)
Pregnant or breast-feeding women. Women of child-bearing potential must have a negative serum β-hCG pregnancy test at Visit 1, must have been using an acceptable method of contraception (section 5.3) for 30 days before the study, and must agree to do so for the whole study and 30 days after (unless post-menopausal or surgically sterile)
Trial design
Treatments tested in this trial
- Xanomeline and trospium chloride (KarXT)
Treatment groups
12 Participants
are divided into 3 treatment groupsSponsors and collaborators
New York State Psychiatric Institute
Lead sponsor
Bristol-Myers Squibb
Collaborator
Source ClinicalTrials.gov