Summary

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• Caplyta (lumateperone) is indicated for the treatment of schizophrenia in adults and for the treatment of depressive episodes associated with bipolar I or II disorder (bipolar depression) in adults, as monotherapy and as adjunctive therapy with lithium or valproate.
• This summary is based on the review of seven systematic review(s)/meta-analysis(es). ^[1-7]
• Schizophrenia: Lumateperone significantly reduced the severity of schizophrenia symptoms compared to placebo, effectively addressing positive, negative, and cognitive symptoms in adults with schizophrenia.
• Bipolar Depression: Lumateperone was more efficacious than placebo in reducing depressive symptoms in adults with acute bipolar depression, demonstrating its effectiveness in this population.
• Comparison with Other Drugs: Lumateperone showed effectiveness in reducing depressive symptoms in bipolar depression, though specific standardized mean differences compared to other drugs were not detailed.
• Lumateperone exhibited a favorable safety and tolerability profile, with placebo-level rates of weight gain, metabolic disruption, akathisia, extrapyramidal side effects, and prolactin elevation, and no significant safety concerns specific to population subgroups.
• Treatment-emergent adverse events (TEAEs) were predominantly mild, with rates of discontinuation due to TEAEs similar to placebo and lower than risperidone; somnolence/sedation and dry mouth were the only TEAEs occurring at a rate of ≥5% and twice that of placebo.