New Data Highlights CAPLYTA® As Promising Option For MDD Remission

Johnson & Johnson has released a new analysis of Phase 3 clinical data showing that CAPLYTA® (lumateperone), used in combination with an antidepressant, achieved significantly higher remission rates in adults with major depressive disorder (MDD) compared with placebo plus an antidepressant at six weeks. The benefits were sustained for up to six months in a large open-label extension study. The findings were presented as part of Johnson & Johnson’s neuropsychiatry portfolio at the 64th Annual Meeting of the American College of Neuropsychopharmacology (ACNP).

The analysis pooled results from two pivotal Phase 3 efficacy and safety trials and a six-month open-label extension study, evaluating remission using multiple thresholds on the Montgomery–Åsberg Depression Rating Scale (MADRS). CAPLYTA demonstrated meaningful improvements across remission, complete remission, and sustained remission, highlighting both the depth and durability of symptom relief. In the short-term trials, nearly twice as many patients achieved remission at six weeks with adjunctive CAPLYTA compared to placebo, with results consistent across age groups, antidepressant classes, and baseline disease severity.

Longer-term data reinforced these findings. In the six-month extension study involving more than 800 patients, nearly two-thirds achieved remission, with a substantial proportion reaching complete and sustained remission over time. Clinicians emphasized that durability of response—not just symptom reduction—is critical for patients, as persistent residual symptoms are associated with relapse, functional impairment, and reduced quality of life.

CAPLYTA was approved by the U.S. Food and Drug Administration in November 2025 as an adjunctive treatment for MDD and is also indicated for schizophrenia and bipolar depression. Johnson & Johnson noted that CAPLYTA does not require dose titration and is being studied across additional neuropsychiatric conditions, though those indications are not yet FDA approved.