Koblan KS, Kent J, Hopkins SC, et al. - Considering a possible value of an oral compound, SEP-363856, that does not act on dopamine D2 receptors but has agonist activity at trace amine–associated receptor 1 and 5-hydroxytryptamine type 1A receptors, as a new class of psychotropic agent for the treatment of psychosis in schizophrenia, researchers conducted a randomized, controlled trial examining if SEP-363856 is efficacious and safe for adults with an acute exacerbation of schizophrenia. For 4 weeks, once-daily treatment with SEP-363856 (50 mg or 75 mg) was provided to a total of 120 patients forming the SEP-363856 group and placebo was provided to 125 forming the placebo group. Per outcomes, a greater reduction occurs from baseline in the the Positive and Negative Symptom Scale (PANSS; range, 30 to 210; higher scores indicate more severe psychotic symptoms) total score among those receiving SEP-363856 than placebo. Somnolence and gastrointestinal symptoms were the adverse events reported with SEP-363856; one sudden cardiac death occurred in the SEP-363856 group.