Summary

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• This summary is based on the review of five systematic review(s)/meta-analysis(es). ^[1-5]
• Lumateperone demonstrated effectiveness in treating both schizophrenia and bipolar disorder, improving positive, negative, and cognitive symptoms in schizophrenia. It also showed greater efficacy than placebo in treating depressive episodes in bipolar patients, with a response rate of ≥50% improvement from baseline on the Montgomery-Asberg Depression Rating Scale (MADRS).
• In schizophrenia, lumateperone was associated with mild weight gain (mean difference ≤1 kg) compared to placebo, which was less than the weight gain observed with many other antipsychotics. Additionally, lumateperone showed favorable tolerability, with lower rates of discontinuation due to adverse events compared to risperidone.
• In a pooled analysis of three randomized, double-blind, placebo-controlled trials, treatment-emergent adverse events (TEAEs) with lumateperone 42 mg were generally mild, with rates of discontinuation due to TEAEs similar to placebo and lower than with risperidone. The most common TEAEs occurring at ≥5% and twice the rate of placebo were somnolence/sedation and dry mouth.
• Lumateperone showed minimal metabolic and weight-related adverse effects, with mean changes in metabolic parameters, prolactin, and weight comparable to or lower than placebo, and fewer extrapyramidal symptoms compared to risperidone.
• The studies included populations with acute exacerbation of schizophrenia and bipolar disorder, showing that lumateperone was effective across these groups. In schizophrenia patients, lumateperone was well tolerated, with safety analyzed in a pooled population of 1073 patients. In bipolar disorder, lumateperone demonstrated efficacy in reducing depressive episodes, with subgroup analysis showing a lower rate of significant weight gain (≥7%) compared to placebo and other treatments.