Clinical trial for SCHIZOPHRENIA 1 (Disorder)
Official title A PET/MRI Study of Cobenfy on Dopamine Transmission in Schizophrenia
ClinicalTrials.gov ID: NCT07423546
What this study is testing
What is Xanomeline and trospium chloride (KarXT)?
An investigational oral medicine being studied as a potential treatment for schizophrenia. It is designed to activate muscarinic receptors in the brain while trospium blocks peripheral muscarinic activity to reduce side effects.
Also referred to as Cobenfy.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to find out whether Cobenfy changes dopamine transmission in the brain, measured with PET scans.
- Who it's for
- Adults diagnosed with schizophrenia or schizoaffective disorder.
- What's involved
- Participants will be randomly assigned to one of three dose levels of Cobenfy for five weeks and will have PET scans before and after treatment.
- Time commitment
- The trial lasts about five weeks and includes two PET scan visits.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 50
You may be able to join if
- 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...
- PANSS total score \> 80 and \< 120
You likely can't join if
- 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...
- EKG abnormality that is clinically significant including a QT interval \> 450 msec for men and \> 470 msec for women, as corrected by the Fridericia...
- 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...
- Any clinically significant or unstable medical illness, condition, or disorder that is anticipated to potentially compromise participant safety on...
- Any material in the body that is a contraindication for MRI procedures or participated in prior nuclear medicine procedures in the past year that...
See the full eligibility criteria
- 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...
- PANSS total score \> 80 and \< 120
- Willing to use qualified methods of contraception (listed in section 5.3) for the study duration (for women of childbearing potential only)
- Stable dosing of herbal/dietary supplements for at least 6 weeks at the time of the first dose of Cobenfy and willingness to avoid products with known hepatotoxic ingredients (e.g., green tea extract, kratom...
- 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...
- 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...
- Any clinically significant or unstable medical illness, condition, or disorder that is anticipated to potentially compromise participant safety on study medication, including (but not necessarily limited to) the...
- Any material in the body that is a contraindication for MRI procedures or participated in prior nuclear medicine procedures in the past year that exceed FDA-defined limits when combined with radiation dosimetry from PET...
- Participants with suicidal ideation with intent or plan (indicated by affirmative answers to items 4 or 5 of the Suicidal Ideation section of the baseline C-SSRS) in the past 1 month or suicidal behavior in the past 3...
- Laboratory abnormality that would compromise the well-being of the participant, including Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) value \> 2 times the upper limit of the laboratory normal...
- A history of treatment resistance to antipsychotics
- Use of nicotine products within the previous month (prior to first PET scan)
- History of significant violent behavior when antipsychotic-free or currently homicidal
- Positive toxicology screen for any substances of abuse
The study team makes the final eligibility decision.
Where it is enrolling
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 50 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at New York, New York, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.