CompletedPhase 2ketamine

Open Label Ketamine Treatment for Major Depressive Disorder in Veterans

NCT ID

NCT03053830

Target Enrollment

11 participants

Start Date

2017-01-31

Est. Completion

2018-09-26

About This Study

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.

Conditions Studied

Major Depressive Disorder

Interventions

•Ketamine

Eligibility

Age:21 Years - 75 Years

Healthy Volunteers:No

View full eligibility 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)

Study Locations (1)

VA Healthcare System

West Haven, Connecticut, United States