Clinical TrialMajor Depressive Disorder (MDD)KetaminePlaceboTerminated

Ketamine Interleaved With Electroconvulsive Therapy for Depression

Pragmatic, randomised, controlled, parallel-group pilot (n=24 planned; 3 actual) of twice-weekly ketamine (0.5 mg/kg) vs midazolam (0.045 mg/kg) infusions interleaved with ECT for a major depressive episode to assess trial processes for a future definitive trial.

Target Enrollment
3 participants
Study Type
Phase I interventional
Design
Randomized, quadruple Blind

Detailed Description

Pragmatic randomised parallel-group pilot comparing twice-weekly sub-anaesthetic ketamine infusions (0.5 mg/kg) with midazolam (0.045 mg/kg) as adjuncts to an ECT course; infusions administered by a consultant anaesthetist with first infusion after the first or second ECT.

Outcomes include physical, psychotomimetic and cognitive measures assessed during and after infusions, with follow-up at six weeks and three months to assess relapse; treatment-as-usual continued throughout.

Study Arms & Interventions

Ketamine

experimental

Twice-weekly ketamine infusions given adjunctive to ECT; administered by consultant anaesthetist; first infusion after first or second ECT.

Interventions

  • Ketamine0.5 mg/kg
    via IV• twice-weekly

    Sub-anaesthetic infusion; administered by consultant anaesthetist; given during ECT course.

Midazolam

active comparator

Twice-weekly midazolam infusions given adjunctive to ECT; administered by consultant anaesthetist.

Interventions

  • Placebo0.045 mg/kg
    via IV• twice-weekly

    Midazolam 0.045 mg/kg (Hyponovel); active comparator; administered by consultant anaesthetist.

Participants

Ages
18 – 99
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • ≥18 years old
  • Able to provide informed consent
  • Voluntary admission for treatment of an acute depressive episode
  • Meet DSM-V criteria for a major depressive disorder (MDD) and bipolar affective disorder (current episode depression)
  • Montgomery Asberg Depression Rating Scale 10 item version (MADRS) score of ≥20
  • Referred for treatment with ECT
  • Sufficiently physically healthy to receive ketamine/midazolam and ECT

Exclusion Criteria

  • Exclusion Criteria:
  • Inability to provide informed consent
  • Current involuntary admission
  • History of Axis 1 diagnosis other than major depression
  • Medical condition rendering unfit for ECT
  • Active suicidal intention
  • Presence of major neurological or organic brain disorder
  • Alcohol/substance dependence in previous six-months
  • Pregnancy or inability to confirm use of adequate contraception during the trial
  • Breastfeeding women
  • Contraindications to ketamine
  • Contraindications to midazolam

Study Details

Locations

St Patrick's University Hospital — Dublin, Co. Dublin, Ireland

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