Clinical TrialMajor Depressive Disorder (MDD)KetamineCompleted

Open Label Ketamine Treatment for Major Depressive Disorder in Veterans

Open-label, single-group study (n=11 actual) delivering up to 6 IV ketamine infusions (0.5 mg/kg, 40 min; once or twice weekly) to Veterans with major depressive disorder to assess safety, tolerability and longer-term effects.

Target Enrollment
11 participants
Study Type
Phase II interventional
Design
Non-randomized

Detailed Description

Open-label, single-group treatment trial of up to six IV ketamine infusions (0.5 mg/kg over 40 minutes) given once or twice weekly to Veterans with major depressive disorder; follow-up at 1, 3 and 6 months.

Primary objectives are to assess safety and tolerability in this population and to examine longer-term clinical effects; all participants continue usual standard care during the trial.

Study Protocol

Preparation

sessions

Dosing

6 sessions
300 min each

Integration

sessions

Study Arms & Interventions

Ketamine infusions

experimental

Up to 6 IV ketamine infusions (0.5 mg/kg) in a single-group open-label design; infusions over 40 minutes with sessions lasting up to 5 hours.

Interventions

  • Ketamine0.5 mg/kg
    via IV• once or twice weekly• 6 doses total

    40 min infusion; sessions up to 5 hours; per PI discretion

Participants

Ages
21 – 75
Sexes
Male & Female

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 Details

Locations

VA Healthcare System — West Haven, Connecticut, United States

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