Caplyta FDA Approval: Benefits for Patients, With Roger McIntyre, MD

Roger S. McIntyre, MD, FRCPC, discusses the latest approval of Caplyta (lumateperone) by the US Food and Drug Administration (FDA) as an adjunct for major depressive disorder.¹

"The approval of Caplyta represents an evidence-based, efficacious treatment as an adjunct to an index antidepressant to alleviate depressive symptoms meaningfully," McIntyre noted. Caplyta has not been associated with many common side effects like weight gain, metabolic disruption, prolactin elevation, or drug-induced movement disorder, he added, meaning that patients have a new effective treatment option.²

With how common and severe major depressive disorder can be, many patients continue to suffer when they fail traditional antidepressant therapy. Caplyta can be a potential adjunct for these patients, which provides patients with more choices that may help their symptoms, McIntyre pointed out. Caplyta can be considered for adjunct treatment for these patients who did not respond to 1 or more antidepressant therapies, and clinicians may want to consider Caplyta early on in treatment progress to provide relief earlier.

Approval of Caplyta presents patients with more options that may effectively treat symptoms of major depressive disorder, and this FDA decision can benefit those looking for choices beyond traditional antidepressant monotherapy.

Read the full news brief on the FDA approval of Caplyta here.

References

1. FDA approval of CAPLYTA® (lumateperone) has the potential to reset treatment expectations, offering hope for remission in adults with major depressive disorder. News release. November 6, 2025. Accessed November 6, 2025. https://www.jnj.com/media-center/press-releases/fda-approval-of-caplyta-lumateperone-has-the-potential-to-reset-treatment-expectations-offering-hope-for-remission-in-adults-with-major-depressive-disorder

2. Earley W. Long-term adjunctive lumateperone treatment in major depressive disorder: results from a six-month open-label extension study. Poster presented at: American Psychiatric Association Annual Meeting; May 17-21, 2025.