Lumateperone as Adjunctive Therapy in Patients With Major Depressive Disorder and Anxious Distress: Post Hoc Analysis of a Phase 3, Randomized, Double-Blind Trial.

Gary S Sachs¹, Suresh Durgam^2,3, Willie R Earley⁴, Susan G Kozauer², Changzheng Chen⁵, Prakash Masand⁶

¹Massachusetts General Hospital, Boston, Massachusetts.

²Former employee of Intra-Cellular Therapies, a Johnson & Johnson company, Bedminster, New Jersey.

³Corresponding Author: Suresh Durgam, MD, former employee of Intra-Cellular Therapies, a Johnson & Johnson company, 135 US Highway 202/206, Suite 6, Bedminster, NJ 07921 (sdpsychiatry@avanagroup.com).

⁴Signant Health, Plymouth Meeting, Pennsylvania (Sachs); Employee of Intra-Cellular Therapies, a Johnson & Johnson company, Bedminster, New Jersey.

⁵Employee of Intra-Cellular Therapies, a Johnson & Johnson company, Bedminster, New Jersey.

⁶Duke-NUS, Singapore.

PubMed DOI

Abstract

Objective: Anxious distress is associated with poor outcomes in the treatment of major depressive disorder (MDD). This exploratory post hoc analysis utilized data from a phase 3 study to investigate adjunctive lumateperone 42 mg efficacy in patients with MDD with inadequate antidepressant therapy (ADT) response and anxious distress. Methods: Outpatients (18-65 y) had DSM-5-defined MDD with inadequ…

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