Clinical TrialMajor Depressive Disorder (MDD)KetamineCompleted

Ketamine for Depression: An MRI Study

Open-label single-group MRI study (n=25) assessing IV ketamine 0.5 mg/kg (40-min infusion) in patients with major depressive disorder to examine brain predictors of antidepressant response.

Target Enrollment
25 participants
Study Type
Phase IV interventional
Design
Non-randomized

Detailed Description

Open-label, single-group study of 25 participants with major depressive disorder receiving a single IV infusion of ketamine (0.5 mg/kg over 40 minutes) with MRI before and after dosing.

Primary clinical outcome measured with the Hamilton Depression Rating Scale (HDRS); MRI data analysed to identify brain regions that predict antidepressant response.

Safety assessed with standard labs, vital signs, and EKG; healthy control cohort included for neuroimaging comparison.

Study Protocol

Preparation

sessions

Dosing

1 sessions
40 min each

Integration

sessions

Study Arms & Interventions

Ketamine + MRI

experimental

Open-label single-group arm: all participants receive IV ketamine and pre/post MRI.

Interventions

  • Ketamine0.5 mg/kg
    via IV• single dose

    0.5 mg/kg infused over 40 minutes

  • Compound
    via Other• single session

    Magnetic Resonance Imaging pre- and post-ketamine; non-drug intervention

Participants

Ages
18 – 64
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria: Patients with Depression
  • Patients will:
  • 1. be 18-64 years old,
  • 2. read, understand, and provide written informed consent in English,
  • 3. meet criteria for a primary psychiatric diagnosis of major depressive disorder for ≥ 4 weeks,
  • 4. have a history of ≥1 failed medication trial during the current depression,
  • 5. be on a stable antidepressant and psychotherapy regimen for ≥28 days,
  • 6. maintain a treating doctor who is in agreement with study participation,
  • 7. have a reliable chaperone accompany them home following the completion of the ketamine infusion day,
  • 8. be generally healthy, as assessed by medical history, physical examination (including vital signs), clinical laboratory evaluations, and electrocardiogram (EKG),
  • 9. be of non-childbearing potential or use an acceptable form of birth control (females only),
  • 10. be right handed.
  • Inclusion Criteria: Healthy Controls
  • Healthy Controls will:
  • 1. be 18-64 years old,
  • 2. read, understand, and provide written informed consent in English,
  • 3. have a reliable chaperone accompany them home following the completion of the ketamine infusion day,
  • 4. be generally healthy, as assessed by medical history, physical examination (including vital signs), clinical laboratory evaluations, and electrocardiogram (EKG),
  • 5. be of non-childbearing potential or use an acceptable form of birth control (females only), and
  • 6. be right handed.

Exclusion Criteria

  • Exclusion Criteria: Patients with Depression
  • Patients will be excluded if any of the following criteria are met:
  • 1) delirium or dementia diagnosis,
  • 2) unstable medical illness or clinically significant laboratory results,
  • 3) history of clinically significant cardiovascular disease or electrocardiogram (EKG) findings, or medical conditions that put the patient at risk for possible cardiac side effects or alter brain morphology (e.g., traumatic brain injury),
  • 4) history of multiple adverse drug reactions,
  • 5) current/past history of psychotic disorders,
  • 6) active substance use disorders (except nicotine and caffeine) within the past six months or past history of ketamine/PCP abuse,
  • 7) requirement of excluded medications that may interact with ketamine,
  • 8) weigh >250 lbs.,
  • 9) pregnancy, breastfeeding, or unacceptable means of birth control (females only),
  • 10) presence of MRI contraindications (e.g., presence of metallic (ferromagnetic) implants (e.g., heart pacemaker, aneurysm clips)),
  • 11) current serious suicidal or homicidal risk,
  • 12) concurrent participation in other research studies.
  • Exclusion Criteria: Healthy Controls
  • Healthy controls will be excluded if any of the following criteria are met:
  • 1. current or past psychiatric diagnosis (excluding phobias), including alcohol or substance abuse or dependence diagnosis (except for nicotine or caffeine),
  • 2. presence of MRI contraindications (e.g., presence of metallic (ferromagnetic) implants (e.g., heart pacemaker, aneurysm clips)),
  • 3. presence of medical illness likely to alter brain morphology and/or physiology (e.g., traumatic brain injury),
  • 4. requirement of excluded medications that may interact with ketamine,
  • 5. presence of psychiatric disorders in first-degree relatives,
  • 6. pregnancy, breastfeeding, or unacceptable means of birth control (females only), or
  • 7. weight >250 lbs.

Study Details

Locations

Massachusetts General Hospital — Boston, Massachusetts, United States

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