Clinical Trial of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder

Summary

This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, fixed-dose study in patients with a primary diagnosis of MDD according to criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) who have an inadequate response to ongoing ADT.

Timeline

Start

2021-07-30

Primary completion

2024-02-22

Completion

2024-02-27

Outcome

Met primary endpoint

paper Lumateperone + ADT met primary and key secondary end points, with significantly greater improvement at day 43 vs placebo + ADT in MADRS Total score PMID 40875502 ↗

registry analysis (superiority test); Lumateperone 42 mg vs Placebo; p <0.0001; Least Squares Mean Difference -4.9 (95% CI -6.38 to -3.44) NCT04985942 ↗

Publications

• Earley WR, Durgam S, Kozauer SG, Chen C, Migliore R, Correll CU. Safety and Tolerability of Adjunctive Lumateperone for the Treatment of Major Depressive Disorder: A Pooled Analysis of Two Randomized Placebo-Controlled Trials. CNS Drugs. 2026 Jul 15. doi: 10.1007/s40263-026-01314-8. Online ahead of print.
• Durgam S, Earley WR, Kozauer SG, Chen C, Lakkis H, McIntyre RS, Stahl S. Lumateperone as Adjunctive Therapy in Patients With Major Depressive Disorder: Results From a Randomized, Double-Blind, Phase 3 Trial. J Clin Psychiatry. 2025 Aug 25;86(4):25m15848. doi: 10.4088/JCP.25m15848.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Lumateperone	Small molecule	42 mg	Oral

Indications