Clinical Trials / Research Studies

Clinical Trials / Research Studies

What will happen in the study?

This study includes 7 onsite study visits over 12 weeks. Here are some of the things that will happen in this study:

Participants will:

• Have health exams including vital sign measurements.

• Be asked about their depression symptoms, antidepressant medications, suicidal thoughts, and sleeping patterns.

• Be randomized (randomly selected like flipping a coin) to either be in the study medication group or the placebo group.

• Take the study drug or placebo daily at bedtime and their current antidepressant medication at the usual time during this period.

• Record study medication dose details in a daily medication diary.

• Complete a sleep diary.

• Submit urine samples.

• Have blood draws.

• Be asked about any side effects from the study medication.

• Have ECGs (electrocardiograms) to record electrical heart activity.

• Be given and asked to wear an electronic device similar to a wristwatch to measure body movements and sleep.

• Complete questionnaires about how they are feeling and functioning, their depression symptoms, and their sleep.