Pharmacist Medication Insights: Lumateperone (Caplyta) for Schizophrenia

Lumateperone (Caplyta) is used to treat schizophrenia and is also used alone or with other drugs to treat depressive episodes in patients with bipolar I or II disorder. Lumateperone should not be used to treat behavioral problems in elderly patients who have dementia.

In December 2021, the FDA approved lumateperone for the treatment of depressive episodes associated with bipolar I or II disorder in adults as monotherapy and as an adjunctive therapy with lithium or valproate.

The approval was based on 2 positive phase 3 placebo-controlled bipolar depression studies, which evaluated the effects of lumateperone on depression in adults with bipolar I or bipolar II disorder both as monotherapy and as adjunctive therapy with lithium or valproate. In the studies, the efficacy of 42 mg lumateperone was established by demonstrating statistically significant improvements over placebo for the change from baseline in the Montgomery-Asberg Depression Rating scale total score at week 6.

The 42 mg dosage also showed a statistically significant improvement in the key secondary endpoint relating to clinical global impression of bipolar disorder in each study.

Furthermore, lumateperone demonstrated a favorable tolerability and safety profile consistent with findings in earlier clinical studies of patients with schizophrenia. The most common reported adverse effect included somnolence or sedation, dizziness, nausea, and dry mouth. Mean changes from baseline in weight, fasting glucose, total cholesterol, triglycerides, and low-density lipoprotein cholesterol were similar between lumateperone and placebo.