Open Label Ketamine Treatment for Major Depressive Disorder in Veterans

A total of 25 depressed subjects between the ages of 21-75 who have current major depressive
disorder without psychotic features by DSM-5 will be recruited. Subjects will be accepted
into the protocol after an opportunity to review and provide voluntary written informed
consent and completion of a comprehensive medical and psychiatric history, physical
examination, mental status examination, and routine laboratory assessments. Patients will be
recruited in outpatient settings to the Refractory Depression Clinic. Providers or Refractory
Depression consult team will be informed if the patient may be eligible for participation in
the ketamine protocol. Subjects must have established care in the VA Connecticut Healthcare
System. If the Veteran is interested, a screening visit for further evaluation for the
ketamine protocol will be scheduled. Veterans will receive up to 6 infusions for ketamine
weekly, per PI discretion. The primary goal of this proposal is to test the effectiveness of
repeated ketamine treatment (0.5 mg/kg; once or twice a week for up to 6 weeks; up to a total
of 6 ketamine infusions). An open-label trial will be conducted that will include up to 25
Veterans with MDD with a follow-up of 6 months. This open-label trial will allow us to
examine the safety and tolerability of the ketamine treatment in this population and the
long-term effects. All patients will receive usual standard care during this trial.

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)