drugset / Trial / NCT05061719
An Open-label Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lumateperone | Small molecule | 42 mg | Oral |