drugset / Trial / NCT05061719

An Open-label Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder

NCT05061719

Phase 3 Completed 812 enrolled Intra-Cellular Therapies, Inc.
NaSingle-groupOpen-labelTreatment

Summary

This is a multicenter, open-label, fixed dose, 26 week study of patients with MDD. Eligible patients from the lead-in studies will enter the Open-label Safety Study at the Screening/Baseline Visit (Visit 1/Day 1), at which point patient eligibility will be assessed and informed consent obtained.

Timeline

Start
2021-10-08
Primary completion
2024-10-14
Completion
2024-10-23

Drugs

EvaluationDrugModalityDoseRoute
Subject Lumateperone Small molecule 42 mg Oral