drugset / Trial / NCT05850689

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

NCT05850689

Phase 3 Recruiting 470 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
2023-05-02
Primary completion
2027-04-05
Completion
2027-04-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Lumateperone Small molecule 42 mg Oral