A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of Adjunctive KarXT in Subjects with Inadequately Controlled Symptoms of Schizophrenia (Karuna Therapeutics)

The first non-antidopaminergic antipsychotic for outpatients. KarXT is a combined formulation of 2 study drugs, xanomeline tartrate and trospium chloride. Xanomeline, a cholinergic agonist, is combined with Trospium (FDA approved), which has been added to reduce the peripheral side effects of xanomeline tartrate, a central muscarinic agonist. KarXT is the first non-anti-dopaminergic antipsychotic to be developed.

The goal of this study is to see if KarXT combined with an antipsychotic drug works better than the current medicine alone. The study is also planned to see if both study drugs taken together are safe and well accepted by patients with schizophrenia.

Study Length

13 weeks (only 6-weeks of active treatment)

Disorder/Condition

Schizophrenia

Inclusion Criteria

The main inclusion criteria are:

Patient is currently being treated with antipsychotic monotherapy (e.g. risperidone, paliperidone, aripiprazole, ziprasidone, lurasidone, or cariprazine) at FDA approved dosages (oral or depot preparations).
The patient has had at least a previous inadequate response to above antipsychotics that was dosed appropriately (within the label) for at least 6 weeks

Compensation and travel arrangement or reimbursement will be provided for eligible participants.

Study Description (brief)

Study Contact

For more information about this study, please contact Benedicto Parker, MD, at (212) 866-2690 or benedicto.parker@omh.ny.gov.

Study Location

Research offices are at the MPC Outpatient clinic (125th street/Adam Clayton Powell Blvd)