Clinical TrialMajor Depressive Disorder (MDD)KetaminePlaceboCompleted

Ketamine Anesthesia for Improvement of Depression in ECT

The purpose of this prospective randomized clinical trial is to determine if patients receiving ketamine as part of general anesthesia during ECT rather than standard of care will have improvement in symptoms of depression after a course of ECT treatments (n≈50).

Target Enrollment
52 participants
Study Type
Phase NA interventional
Design
Randomized, double Blind

Detailed Description

Randomized, double-blind, parallel-group trial in VA patients undergoing ECT comparing ketamine (1.0 mg/kg IV) versus methohexital (1.0 mg/kg IV) for induction across the ECT index course.

Primary outcomes are change in depression scores (PHQ-9 and HAM-D) from baseline to final ECT; secondary outcomes include cognitive status (MoCA), seizure quality (EEG), cerebral oximetry, serum metabolites (kynurenine, D/L-serine, glutamate intermediates), and relapse/need for further ECT within 1 year.

Approximately 50 veterans receiving care at VA Puget Sound will be randomized; operative ECT clinicians are unblinded while outcome assessors and participants are blinded.

Study Arms & Interventions

Ketamine

experimental

1.0 mg/kg IV ketamine for induction during ECT index course (over 2–3 weeks).

Interventions

  • Ketamine1 mg/kg
    via IV• during ECT index course

    Ketalar

Methohexital

active comparator

1.0 mg/kg IV methohexital for induction during ECT index course (over 2–3 weeks).

Interventions

  • Placebo1 mg/kg
    via IV• during ECT index course

    Methohexital (Brevital)

Participants

Ages
18 – 99
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • Outpatients or inpatients at the Puget Sound VA with diagnosis of major depressive disorder or bipolar I or II, aged ≥18, undergoing index course ECT.

Exclusion Criteria

  • Exclusion Criteria:
  • Uncontrolled hypertension (blood pressure > 180/90 mmHg at the pre-anesthesia clinic visit)
  • Renal failure
  • Neurologic disorders (e.g. epilepsy, space-occupying lesions, traumatic brain injuries in the past 6 months)
  • Myocardial infarction in the past 6 months
  • Known allergies or adverse reactions to ketamine
  • American Society of Anesthesiology Physical Class > 3
  • Concomitant psychosis
  • Schizophrenia or current abuse of alcohol or illicit substances
  • Pregnancy (any trimester)

Study Details

Locations

VA Puget Sound Health Care System — Seattle, Washington, United States

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