Open Label Ketamine Treatment for Major Depressive Disorder in Veterans

• Status: Active, not recruiting
• Trial end date: 2021-06-30
• Target enrollment: 0
• Participant gender: All

Summary

Medically healthy Veterans ages 21-75 that have been diagnosed with Depression will get up to 6 treatments of Ketamine infusions, weekly. After treatment is completed, follow up will occur at 1 month, 3 months, and 6 months after completion of infusions to evaluate the longer term effects of ketamine.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: VA Connecticut Healthcare System
• Treatments: Ketamine

Criteria

Inclusion Criteria:

1. Male or female, 21-75 years old

2. Current major depressive disorder without psychotic features by DSM-5

3. Montgomery-Åsberg Depression Rating Scale (MADRS) ≥ 20

4. Able to provide written informed consent

Exclusion Criteria:

1. Current or past history of psychotic features or psychotic disorder

2. Current or past history of delirium or dementia

3. Current uncontrolled hypertension (systolic BP > 170 mm Hg or diastolic BP > 100 mm Hg)

4. Unstable medical condition or allergy to ketamine or lorazepam---clinically determined by a physician

5. Pregnant or nursing women, positive pregnancy test, or inadequate birth control methods in women of childbearing potential

6. Positive opioid or illicit drug screen test (except marijuana)