Drug updated on 9/4/2024
Dosage Form | Capsule (oral; 42 mg) |
Drug Class | Atypical antipsychotics |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of schizophrenia in adults.
- Indicated 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.
Latest News
Summary
- 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.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Caplyta (lumateperone) Prescribing Information. | 2023 | Intra-Cellular Therapies, Inc., New York, NY |