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

ConditionsSCHIZOPHRENIA 1 (Disorder)Schizoaffecitve Disorder

Trial statusRecruiting

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

Xanomeline and trospium chloride (KarXT)
Drug
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.

Treatment groups

12 Participants

are divided into 3 treatment groups

Group A: Xanomeline 50 mg and trospium chloride 20mg (KarXT)Experimental treatment 1 intervention

Group B: Xanomeline 100 mg and trospium chloride 20mg (KarXT)Experimental treatment 1 intervention

Group C: Xanomeline 125 mg and trospium chloride 30mg (KarXT)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

[18F]DOPA Kicer ([18F]DOPA relative uptake rate)

Time frame

Pre/post 5 weeks of Xanomeline and trospium chloride (KarXT)

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

New York State Psychiatric Institute

Lead sponsor

Bristol-Myers Squibb

Collaborator

Source ClinicalTrials.gov

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