CAPLYTA adjunctive depression data: 25.5% reach remission at six weeks versus 13.6% on placebo

Johnson & Johnson presented pooled Phase 3 analyses of CAPLYTA taken with an antidepressant for major depressive disorder at the ACNP 2026 meeting. Six-week remission was 25.5% on CAPLYTA plus an antidepressant versus 13.6% on placebo plus an antidepressant, a nominal p-value below 0.0001. A six-month open-label extension showed 65.4% of 529 patients reaching remission, though that study had no placebo arm.

• Six-week remission (MADRS 10 or lower): 25.5% versus 13.6% for placebo, nominal p below 0.0001
• Six-week complete remission (MADRS 5 or lower): 10.6% versus 5.6%, p below 0.01
• Six-month open-label extension: 65.4% of 529 patients reached remission
• Data presented January 12-15, 2026 at the 64th ACNP meeting in Nassau, Bahamas