Cobenfy Study

Efficacy and tolerability of Xanomeline/Trospium in First Episode/Early Phase Schizophrenia

Objective

What is the purpose of this study? Schizophrenia is a condition that negatively affects people's mental health in different ways. For example, it can affect a person's mood, behavior, or cognition. Cobenfy is a new FDA approved drug for the treatment of the positive symptoms of schizophrenia. Cobenfy is different from other antipsychotics as it has a new "mechanism of action"; compared to all other antipsychotics approved from the treatment of schizophrenia at this time. Since Cobenfy is the first medication of its drug class to be FDA approved for schizophrenia, researchers are interested to know how this new class of antipsychotics affects those with early phase schizophrenia specifically. This clinical trial will test if Cobenfy can help improve the positive symptoms of patients with first episode/early phase schizophrenia, better than other antipsychotics.

To be eligible to participate, you must:

  • Be at least 18 years or older
  • Have a primary diagnosis of schizophrenia
  • Have been on a stable dose of 1 antipsychotic medication for at least 8 weeks before treatment with no
    dose changes within the last 4 weeks.
  • Have started your first antipsychotic treatment within the past 5 years.

Patients who meet eligibility criteria and enroll will come into our office to receive the study drug. Once enrolled, in-person clinic visits will occur every 1-4 weeks for about 24 weeks until the end of treatment visit, with a final follow-up visit 28 days after you last take the study drug (no more than 13 visits total).

If you decide to participate, the study drug will be provided by/paid for by our clinic and study related assessments will be conducted during clinic visits. You may also be compensated for your participation and be reimbursed for any study-related travel.

Want to learn more?

If you or someone you know is interested in learning more about this research study, please feel free to contact us by calling 201-846-2164 or emailing khamoudeh@newbridgehealth.org

Clinical Trial Categories

  • Early Phase Schizophrenia
How to Participate

For more information please email

khamoudeh@newbridgehealth.org

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