Clinical Trial TitleThis is a placebo-controlled study of brexpiprazole or placebo in combination with intranasal ketamine added to ongoing antidepressant therapy in the treatment of treatment-resistant depression.
Clinical Trial Protocol Description:
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.
Clinical Trial Eligibility Criteria:
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.