FDA Approves Lumateperone for Major Depressive Disorder
Here’s a breakdown of the references provided, formatted for clarity:
1. Press Release:
* Source: Johnson & Johnson (JNJ) Media Center
* Title: FDA Approval of Caplyta (lumateperone) Has the Potential to Reset Treatment Expectations, Offering Hope for Remission in Adults with Major depressive Disorder
* URL: 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. Clinical Trial (Adjunctive Therapy):
* Study Name: Clinical trial of lumateperone as adjunctive therapy in the treatment of patients with major depressive disorder.
* Identifier: NCT04985942
* Last Updated: May 2,2025
* Accessed: November 6,2025
* URL: https://clinicaltrials.gov/study/NCT04985942?tab=results
3. Journal Article:
* Authors: durgam S, Earley WR, Kozauer SG, et al.
* Title: Lumateperone as adjunctive therapy in patients with major depressive disorder: Results from a randomized, double-blind, phase 3 trial.
* Journal: J Clin Psychiatry
* Year: 2025
* Volume/Issue: 86(4):25m15848
* DOI: 10.4088/JCP.25m15848
4. Clinical Trial (Adjunctive Therapy – Multicenter):
* Study Name: Multicenter study of lumateperone as adjunctive therapy in the treatment of patients with major depressive disorder.
* Identifier: NCT05061706
* Last Updated: May 9, 2025
* Accessed: November 6, 2025
5. Journal Article (pooled Analysis):
* Authors: Durgam S, Earley W, Kozauer S, et al.
* Title: Efficacy of lumateperone 42 mg in the treatment of major depressive disorder: A pooled analysis of phase 3 randomized controlled trials.
* Journal: In (The journal name is incomplete in the provided text.)