Clinical TrialMajor Depressive Disorder (MDD)KetamineKetamineCompleted

Ketamine + Mindfulness for Depression

Double-blind, randomised, parallel RCT (n=43) testing a single IV ketamine infusion (0.5 mg/kg over 40 min) with brief mindfulness training versus academic exercises in adults with unipolar depression.

Target Enrollment
43 participants
Study Type
Phase I/II interventional
Design
Randomized, double Blind

Detailed Description

Randomised, double-blind, parallel-group trial in adults with unipolar depression comparing a single intravenous ketamine infusion (0.5 mg/kg over 40 minutes) delivered with either brief mindfulness exercises or matched academic exercises.

Participants receive a 30‑minute preparatory session (mindfulness training or academic tasks) immediately prior to infusion; outcomes assess changes in depression scores following a single infusion.

Study Protocol

Preparation

1 sessions
30 min each

Dosing

1 sessions
40 min each

Integration

sessions

Therapeutic Protocol

mindfulness

Study Arms & Interventions

Ketamine + Mindfulness

experimental

Single IV ketamine infusion paired with brief mindfulness training immediately prior to infusion.

Interventions

  • Ketamine0.5 mg/kg
    via IV• single infusion• 1 doses total

    0.5 mg/kg over 40 minutes

  • Compound
    via Other• single session

    30 min guided mindfulness training immediately prior to infusion

Ketamine + Academic Exercises

active comparator

Single IV ketamine infusion paired with academic/mental-arithmetic exercises immediately prior to infusion.

Interventions

  • Ketamine0.5 mg/kg
    via IV• single infusion• 1 doses total

    0.5 mg/kg over 40 minutes

  • Compound
    via Other• single session

    30 min academic cognitive exercises (mental math) immediately prior to infusion

Participants

Ages
18 – 65
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • 1. Age 18–65 years.
  • 2. Score ≥14 on the Hamilton Depression Rating Scale (modified Ham-D).
  • 3. Capacity to consent and agree to study procedures.

Exclusion Criteria

  • Exclusion Criteria:
  • 1. Lifetime bipolar disorder, psychotic disorder, or autism spectrum disorder.
  • 2. Current problematic substance use or moderate-to-severe substance use disorder.
  • 3. Acute suicidality or psychiatric crises requiring escalation (CSSRS used at screening; positive items 4 or 5 excluded).
  • 4. Changes to treatment regimen within 4 weeks of baseline.
  • 5. Reading level <6th grade by self-report.
  • 6. ECT within 2 months prior to screening.
  • 7. Current pregnancy or breastfeeding.
  • 8. Unstable/serious medical illnesses (e.g., significant respiratory, cardiovascular, neurologic conditions) or contraindications to ketamine as determined by physician.
  • 9. Clinically significant abnormal labs, urine toxicology, vitals, or ECG.
  • 10. Uncontrolled hypertension.
  • 11. History of seizures without resolved etiology.
  • 12. Initiation of hormonal treatment in 3 months prior to screening.
  • 13. Past intolerance or hypersensitivity to ketamine.
  • 14. Use of medications with activity at NMDA/AMPA receptors or strong interacting agents (riluzole, amantadine, memantine, topiramate, dextromethorphan, D-cycloserine, St John's Wort, theophylline, tramadol, metrizamide).

Study Details

Locations

Western Psychiatric Institute and Clinic — Pittsburgh, Pennsylvania, United States

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