Johnson & Johnson has released a new analysis of Phase 3 clinical data showing that CAPLYTA, when used alongside an antidepressant, produced significantly higher remission rates in adults with major depressive disorder compared to placebo combined with an antidepressant after six weeks of treatment. These improvements continued through six months in an open-label extension study. The results were highlighted as part of eleven abstracts presented from Johnson & Johnson’s neuropsychiatry portfolio at the 64th Annual Meeting of the American College of Neuropsychopharmacology held from January 12 to 15 in Nassau, Bahamas.
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Major depressive disorder affects nearly 22 million adults in the United States. Although the ultimate goal of treatment is remission or full relief from depressive symptoms, most patients do not reach this milestone with existing therapies. Those who continue to experience symptoms often face long-term social and functional impairment, an increased risk of relapse, and a lower quality of life. The condition also carries a significant economic burden and is the leading cause of disability in the United States.
The analysis pooled data from three Phase 3 studies of CAPLYTA, including two pivotal trials known as Studies 501 and 502, and a six-month open-label extension safety study, Study 503. Researchers measured remission using the Montgomery-Asberg Depression Rating Scale. Remission was defined as a MADRS score of ten or lower, complete remission as a MADRS score of five or lower, and sustained remission as maintaining a MADRS score of ten or lower at each assessment. Across all measures, CAPLYTA demonstrated meaningful remission rates, reflecting both the depth and durability of symptom relief for patients with major depressive disorder.
“Most patients with depression are still struggling with persistent symptoms that affect their daily lives,” said Michael E. Thase, M.D., Professor of Psychiatry and Chief of the Division of Mood and Anxiety Disorders Treatment & Research Program at the Perelman School of Medicine at the University of Pennsylvania. “These findings show not only symptom reduction but also sustained and meaningful treatment response. Adjunctive lumateperone nearly doubles the likelihood of remission over six months and offers new hope to millions seeking recovery.”
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In the pivotal studies, nearly twice as many patients taking CAPLYTA plus an antidepressant reached remission at six weeks compared to those taking placebo plus an antidepressant, 25.5 percent versus 13.6 percent. Complete remission was achieved by 10.6 percent of patients on CAPLYTA compared to 5.6 percent on placebo. These benefits were consistent across age groups, baseline severity, and type of antidepressant. In the six-month open-label extension, 65.4 percent of patients reached remission, 44.1 percent achieved complete remission, and 42.8 percent experienced sustained remission by the end of the study, with rates gradually increasing from week eight to week 24.
“What matters most to patients is sustained relief that allows them to reclaim their lives,” said Bill Martin, Ph.D., Global Therapeutic Area Head for Neuroscience at Johnson & Johnson Innovative Medicine. “Too many patients have spent years cycling through treatments without full relief. These results show that remission should be expected rather than hoped for.”
CAPLYTA was approved by the U.S. Food and Drug Administration in November 2025 as an adjunctive treatment for major depressive disorder. It is also approved for schizophrenia and depressive episodes associated with bipolar I or II disorder. The drug works by occupying serotonin 5-HT2A receptors while moderately affecting dopamine D2 receptors. CAPLYTA does not require dose titration, allowing patients to begin treatment at an effective dose of 42 milligrams. A supplemental New Drug Application has been submitted to the FDA to evaluate its long-term efficacy in preventing relapse in schizophrenia, and studies are ongoing to explore its use in other neuropsychiatric disorders.
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Source- PR Newswire
