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

Inclusion Criteria:

1. In the opinion of the Investigator, patients must have safely completed the lead-instudy.

2. Patient is taking their ADT as prescribed from the lead-in study.

Exclusion Criteria:

1. In the opinion of the Investigator, the patient is unable to comply with studyprocedures or judged to be inappropriate for the study.

2. In the opinion of the Investigator, the patient has a significant risk for suicidalbehavior during the course of her/his participation in the study or is considered tobe an imminent danger to her/himself or others, and/or:

3. At the Screening/Baseline Visit, the patient scores "yes" on Suicidal IdeationItems 4 or 5 of the C SSRS "Since Last Visit" version;

4. At the Screening/Baseline visit, the patient scores ≥ 5 on the MADRS Item 10 (Suicidal Thoughts).

5. Based on the Investigator's clinical judgement, any abnormal clinical laboratorytest or ECG results obtained throughout the lead-in study that are consideredclinically significant and preclude safe participation in the study.