What will happen in the study?

This study includes 9 onsite study visits over 9 weeks. Here are some of the things that will happen in this study.

To find out the best way of treating people with MDD, we need to compare different treatments. People are placed into groups, and each group is given a different study treatment. Each participant is put into a group by chance (this is called randomization). The randomization method is set up so that you have an equal chance of receiving either study drug or placebo.

You will:

• Be assigned by chance (by a computer) to one of the following groups:
  1.  The study drug (lumateperone) group with 42 mg capsule taken orally once a day, in the evening.
  2.  The placebo capsule group with the capsule taken orally once a day, in the evening.
• Continue to take your antidepressant medication as prescribed.
• Have health exams including vital sign measurements.
• Be asked questions about your health, medical history, and medications.
• Submit urine samples.
• Have blood draws.
• Have ECGs (electrocardiograms) to record electrical heart activity.
• Inform the study doctor of any changes in your health and any side effects that you may experience during the study.