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In December 2019, the FDA approved the new antipsychotic drug lumateperone tosylate. In an industry-sponsored, 1-month, randomized clinical trial, investigators compared lumateperone at 28 or 42 mg (tosylate equivalents, 40 mg and 60 mg, respectively) or placebo in 450 patients with an acute exacerbation of schizophrenia (mean age, 42). The manufacturer sponsored the study's design, conduct, data analysis, and publication, and several authors had financial ties to the sponsor.
The 42-mg dose (but not the 28-mg dose) was associated with significantly greater improvement of scores on the Positive and Negative Syndrome Scale (PANSS) than placebo in analyses that were not corrected for multiple comparisons; the corrected analysis just reached st…