Multicenter Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder

Phase 3 Completed 480 enrolled Intra-Cellular Therapies, Inc.

RandomizedParallel-groupTriple-blindTreatment

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: 2021-09-30
Primary completion: 2024-04-12
Completion: 2024-04-12

Outcome

Met primary endpoint

registry analysis (superiority test); Lumateperone 42 mg vs Placebo; p <0.0001; Least Squares Mean Difference -4.5 (95% CI -6.03 to -3.02) NCT05061706 ↗

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.

Drugs

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