Clinical TrialDepressive DisordersKetaminePlaceboCompleted

Ketamine as an Augmentation Strategy for Electroconvulsive Therapy (ECT) in Depression

Double-blind, randomised, parallel pilot study (n≈31) comparing ketamine (1–2 mg/kg IV) versus methohexital (0.5–1 mg/kg IV) anesthesia during ECT for depressive episodes to assess speed of remission and cognitive side effects.

Target Enrollment
31 participants
Study Type
Phase IV interventional
Design
Randomized, quadruple Blind

Detailed Description

This double-blind randomised controlled pilot compares therapeutic efficacy and cognitive side effects of ECT performed with ketamine versus methohexital anaesthesia in patients with major depressive episodes (unipolar and bipolar).

Participants receive a standard acute course of bifrontal ECT (3x/week) with ketamine 1–2 mg/kg IV or methohexital 0.5–1 mg/kg IV; MRI (structural and functional) is collected at baseline, <36 hours after first ECT, and after nine ECTs or at remission to assess neurobiological changes.

Study Arms & Interventions

Ketamine

experimental

Ketamine anaesthesia during ECT; IV 1–2 mg/kg

Interventions

  • Ketamine1 - 2 mg/kg
    via IV• each ECT

    IV ketamine 1–2 mg/kg as anaesthetic for ECT

Methohexital

active comparator

Methohexital anaesthesia during ECT; IV 0.5–1 mg/kg

Interventions

  • Placebo0.5 - 1 mg/kg
    via IV• each ECT

    Methohexital 0.5–1 mg/kg IV (Brevatol) as active comparator

Participants

Ages
18 – 70
Sexes
Male & Female

Inclusion Criteria

  • 1. Male or female subjects 18 to 70 years of age
  • 2. Diagnostic Statistical Manual (DSM) IV diagnosis of Major Depression (296.3), unipolar without psychotic features or Bipolar I or Bipolar II Depression without psychotic features confirmed by Structured Clinical Interview for DSM-IV (SCID-IV) interview
  • 3. Pretreatment 24-item Hamilton Rating Scale for Depression score > 21
  • 4. Subjects must have an initial score of at least 20 on the Montgomery-Asbergers Depression Rating Scale (MADRS) at screen
  • 5. ECT is clinically indicated
  • 6. Patient is competent to provide informed consent

Exclusion Criteria

  • 1. Lifetime DSM-IV diagnosis of schizophrenia, schizoaffective disorder, psychotic depression or any other psychotic disorder as defined in the DSM-IV
  • 2. Current (within the last year) 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 amnesiac disorder
  • 4. Diagnosis of Mental Retardation
  • 5. Baseline Mini Mental State Exam (MMSE) score < 21 or a total score falling two standard deviations below the age- and education-adjusted mean, whichever is less
  • 6. Any active general medical condition or central nervous system (CNS) disease which can affect cognition or response to treatment
  • 7. Current (within the past three months) diagnosis of active substance dependence, or active substance abuse within the past week
  • 8. Lifetime history of ketamine or phencyclidine (PCP) abuse or dependence
  • 9. ECT within three months
  • 10. 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
  • 11. Pregnancy
  • 12. Status 4 or greater according to the criteria of the American Society of Anesthesiologists
  • 13. MRI contraindications

Study Details

  • Status
    Completed
  • Phase
    Phase IV
  • Type
    interventional
  • Design
    Randomizedquadruple Blind
  • Target Enrollment31 participants
  • Timeline
    Start: 2010-01-06
    End: 2017-01-07
  • Compounds
    KetaminePlacebo
  • Topic
    Depressive Disorders

Locations

Zucker Hillside Hospital — Glen Oaks, New York, United States

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