SUMMARY  

• Like other antipsychotic drugs, CAPLYTA may cause seizures. The risk of antipsychotic drug-associated seizures is greatest in patients with a history of seizures or with conditions that lower the seizure threshold. Conditions that lower the seizure threshold may be more prevalent in older patients.¹   
• In a 4-week, phase 3, multicenter, double-blind, randomized, placebo-controlled, inpatient clinical trial investigating the efficacy and safety of CAPLYTA in adults with schizophrenia and acute exacerbation of psychosis, 1 patient (0.7%) in the lumateperone 28 mg group experienced a treatment-emergent adverse event (TEAE) of convulsion. This TEAE was severe and deemed serious. The patient discontinued treatment. The patient had preexisting risk factors and relevant medical history regarding seizures. Patients with a history of seizure disorder were excluded from the study; however, this patient was inappropriately randomized because of incomplete medical history and inaccurate self-reporting at screening.² 
• Epilepsy was an exclusion criteria in a phase 2 trial of patients with schizophrenia, two phase 3 trials of patients with bipolar depression, and two phase 3 trials of patients with major depressive disorder.^3-7 

Literature Search

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and DERWENT^® (and/or other resources, including internal/external databases) was conducted on 12 September 2025.