Clinical TrialDepressive DisordersKetaminePlaceboCompleted

Ketamine Anesthesia in Electroconvulsive Therapy

The study hypothesis was that depressed subjects receiving ECT with ketamine as the anesthetic agent would demonstrate a faster rate of improvement, defined as lower depression ratings after the second ECT than depressed patients receiving ECT with the usual anesthetic agent.

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

Detailed Description

Randomized, double-blind, parallel-group trial comparing ketamine versus methohexital as the anesthetic agent for patients receiving ECT; each drug given at approximately 1.0 mg/kg and patients received the same anesthetic for up to six ECT treatments.

Outcomes included depressive severity, cognition, post-anesthesia side effects, and hemodynamics; subjects were followed while receiving inpatient ECT and the number of treatments was determined by their primary psychiatric team blinded to anesthetic.

Study Protocol

Preparation

sessions

Dosing

6 sessions

Integration

sessions

Study Arms & Interventions

Ketamine

experimental

Ketamine ~1.0 mg/kg as anesthetic prior to ECT (up to six treatments).

Interventions

  • Ketamine1 mg/kg
    via IV• single dose• 6 doses total

    Given prior to each ECT session; up to six treatments.

Methohexital

active comparator

Methohexital ~1.0 mg/kg as anesthetic prior to ECT.

Interventions

  • Placebo1 mg/kg
    via IV• single dose

    Methohexital ~1.0 mg/kg (active comparator).

Participants

Ages
18 – 99
Sexes
Male & Female

Inclusion Criteria

  • Inclusion criteria:
  • Diagnosis of depression, either unipolar or bipolar
  • Subjects receiving ECT at the Mayo Clinic

Exclusion Criteria

  • Exclusion criteria:
  • Subjects not giving their own consent to ECT
  • Subjects with schizophrenia, schizoaffective disorder, or dementia
  • Subjects diagnosed with a major neurological disorder such as epilepsy, Parkinson disease, multiple sclerosis, or a neurodegenerative dementia.

Study Details

  • Status
    Completed
  • Phase
    Phase NA
  • Type
    interventional
  • Design
    Randomizeddouble Blind
  • Target Enrollment38 participants
  • Timeline
    Start: 2011-01-05
    End: 2021-01-03
  • Compounds
    KetaminePlacebo
  • Topic
    Depressive Disorders

Locations

Mayo Clinic in Rochester — Rochester, Minnesota, United States

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