Medication Treatment Study for Patients with Treatment-Resistant Depression

To evaluate the effectiveness, safety and tolerability of brexpiprazole in combination with intranasal ketamine, compared to placebo, as a rapidly acting treatment for treatment-resistant depression.

In order to participate you must meet the following criteria:

• Are between the ages of 18-65 years old.
• Meet criteria for treatment-resistant depression and have been experiencing depression for at least the past 8 weeks.
• Are willing and able to use birth control (if you are a female of childbearing potential).

You will be excluded from the study if any of the following criteria apply to you:

• Have certain other psychiatric or unstable medical illness, including bipolar disorder.
• Test positive for drugs of abuse or alcohol at the time of screening.
• Have had prior treatment with vagus nerve stimulation (VNS).
• Are pregnant or breastfeeding.

This is a partial list of inclusion and exclusion criteria.