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Antipsychotic medications are the mainstay of schizophrenia treatment but have limited efficacy against negative and cognitive symptoms, pose considerable side effects, and share the same mechanism of action (D2 receptor blockade). To examine the efficacy of a non–FDA-approved antipsychotic (SEP-363856) with a novel mechanism of action at the trace amine–associated and serotonin 5-HT1A receptors, international researchers conducted a manufacturer-funded, multisite, placebo-controlled, randomized 4-week study with an open-label 26-week extension. The 245 adults with schizophrenia (age, ≤40) had an acute psychotic exacerbation (duration, ≤2 months) and scored at least 80 on the Positive and Negative Syndrome Scale (PANSS; mean, 101).
Dropout w…