Drug updated on 4/18/2024
| 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.
Summary
- Lumateperone (Caplyta) is indicated for the treatment of schizophrenia and depressive episodes associated with bipolar I or II disorder in adults. It has demonstrated effectiveness in managing both positive and negative aspects, along with cognitive symptoms associated with these conditions.
- The information was derived from seven systematic reviews/meta-analyses concerning Caplyta's use in treating schizophrenia and depressive episodes linked to bipolar disorders.
- Compared to placebo, lumateperone significantly reduced the severity of schizophrenia symptoms. It also exhibited a favorable safety profile, notably showing placebo-level rates of weight gain, metabolic shifts, prolactin elevation, extrapyramidal side effects (EPS), and akathisia in short-term trials.
- In terms of antipsychotic-induced weight gain (AIWG), lumateperone presents a favorable profile compared to other antipsychotics as it shows minimal association with this common adverse effect.
- Regarding cardiovascular diseases and diabetes incidence rates related to lifetime costs associated with antipsychotic treatments choice within European contexts, although lurasidone and ziprasidone held slightly more advantageous positions economically speaking, lumateperone still emerged as cost-effective considering its broader scope on adverse events management including weight gain control.
- While comprehensive subgroup analyses specific to different populations were not detailed in the studies; overall efficacy data underscored that lumateperone can be applicable across adult populations dealing either schizophrenia or bipolar disorders.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Caplyta (lumateperone) Prescribing Information. | 2023 | Intra-Cellular Therapies, Inc., New York, NY |