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Medication Treatment Study for Patients with Treatment-Resistant Depression

Clinical Trial Title: 
This 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 ID: 
Clinical Trial Investigator Name: 
John Zajecka, MD
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.

Clinical Trial Area: 
Mental Health Disorders
Contact Phone: 
(312) 942-6597
Contact Name: 
Linda Skaggs