Clinical TrialDepressive DisordersKetaminePlaceboTerminated

Use of Ketamine to Enhance Electroconvulsive Therapy (ECT) in Depression

The primary objectives of this study are to investigate the potential for ketamine anaesthesia to increase the antidepressant efficacy of Electroconvulsive therapy (ECT) and to decrease acute ECT-induced adverse cognitive effects.

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

Detailed Description

This randomised, parallel-group pilot study compared ketamine versus methohexital anaesthesia in patients receiving ECT for major depressive episodes to assess antidepressant efficacy and acute cognitive side-effects.

Outcomes included depression rating scales, cognitive assessments, seizure duration/morphology, and haemodynamic and behavioural responses; ketamine dosing was 1–2 mg/kg IV and methohexital 1 mg/kg IV as indicated for ECT.

Study Arms & Interventions

Ketamine

experimental

Participants receiving ECT randomised to ketamine anaesthesia.

Interventions

  • Ketamine1 - 2 mg/kg
    via IV• as indicated for ECT

    Ketamine 1–2 mg/kg IV as indicated for ECT

Methohexital

active comparator

Participants receiving ECT randomised to methohexital (standard anaesthetic).

Interventions

  • Placebo1 mg/kg
    via IV• as indicated for ECT

    Methohexital 1 mg/kg IV as indicated for ECT (active comparator)

Participants

Ages
18 – 65
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • 1. Male or female patients: 18 to 59 years
  • 2. Women of childbearing potential must agree to use a medically accepted means of contraception for the duration of the study
  • 3. DSM IV MINI diagnosis of major depressive episode (MDD), unipolar or bipolar
  • 4. Pretreatment 24-item Hamilton Rating Scale for Depression score > 21
  • 5. ECT is clinically indicated
  • 6. Patient has the capacity to provide informed consent.

Exclusion Criteria

  • Exclusion Criteria:
  • 1. DSM-IV diagnosis of schizophrenia, schizoaffective disorder, or mental retardation
  • 2. Current primary diagnosis of anxiety disorder, obsessive- compulsive disorder, or eating disorder that precedes the onset of the current episode of depression
  • 3. Current diagnosis of delirium, dementia, or amnestic disorder
  • 4. Baseline Mini Mental State Exam (MMSE) score < 24 and a total score falling two standard deviations below the age- and education-adjusted mean
  • 5. Any active general medical condition or CNS disease which can affect cognition or response to treatment
  • 6. Current (within the past three months) diagnosis of active substance dependence, or active substance abuse within the past week
  • 7. Lifetime history of ketamine or PCP abuse or dependence
  • 8. ECT within three months
  • 9. The presence of any known or suspected contraindication to methohexital or ketamine including but not limited to known allergic reactions to these agents, uncontrolled hypertension arrhythmia severe coronary artery disease and porphyria
  • 10. Pregnancy

Study Details

  • Status
    Terminated
  • Phase
    Phase NA
  • Type
    interventional
  • Design
    Randomizeddouble Blind
  • Target Enrollment3 participants
  • Timeline
    Start: 2010-04-01
    End: 2010-10-01
  • Compounds
    KetaminePlacebo
  • Topic
    Depressive Disorders

Locations

Icahn School of Medicine at Mount Sinai — New York, New York, United States

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