By VETTAPHARMA reporter: TITUSVILLE, NJ (January 16, 2026) — New clinical data released by Johnson & Johnson reveal that CAPLYTA® (lumateperone), when used alongside an antidepressant, significantly improved remission rates in adults living with major depressive disorder (MDD), with sustained benefits observed over six months. The findings were featured at the 64th Annual Meeting of the American College of Neuropsychopharmacology (ACNP) held earlier this month.
The analysis pooled results from two pivotal Phase 3 efficacy and safety trials (Studies 501 and 502) and a six-month open-label extension safety study (Study 503). It focused on three measures of remission — standard remission (MADRS ≤10), complete remission (MADRS ≤5), and sustained remission (MADRS ≤10 maintained at all assessments). Across all measures, CAPLYTA® showed meaningful improvements compared to placebo when added to ongoing antidepressant therapy.
At six weeks, the data indicated that patients receiving adjunctive CAPLYTA® were nearly twice as likely to reach remission as those receiving placebo plus an antidepressant (25.5% vs. 13.6%). Complete remission rates also favored CAPLYTA® plus an antidepressant over placebo (10.6% vs. 5.6%). Longer-term follow-up in Study 503 further underscored these benefits:
- 65.4% of patients achieved remission after six months of treatment with CAPLYTA®
- 44.1% reached complete remission
- 42.8% maintained sustained remission by the study’s end, with rates increasing throughout treatment
Experts involved in the research emphasized the importance of not just symptom reduction but achieving lasting relief for patients. According to the press release, many adults with MDD do not attain remission with currently available therapies, highlighting the ongoing need for more effective treatment options.
CAPLYTA® was approved by the U.S. Food and Drug Administration (FDA) in November 2025 as an adjunctive therapy for MDD in adults already taking an antidepressant, expanding its existing indications for schizophrenia and depressive episodes associated with bipolar I or II disorder.
This new analysis contributes to the growing body of evidence suggesting that adjunctive use of CAPLYTA® may help many patients reach the ultimate goal of remission — providing a deeper and more durable improvement in symptoms than antidepressant therapy alone.
Source Credit:
- Johnson & Johnson. (2026, January 16). New clinical data highlights CAPLYTA® (lumateperone) as a promising option for achieving remission in adults with major depressive disorder [Press release]. Click here
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