Clinical TrialMajor Depressive Disorder (MDD)KetamineCompleted

Ketamine as an Alternative Treatment to ECT in Major Depressive Disorder

Randomised, parallel-group non-inferiority trial (n=198) comparing racemic ketamine IV infusions (0.5 mg/kg over 40 minutes, thrice weekly) with ECT in inpatients with severe MDD.

Target Enrollment
198 participants
Study Type
Phase II/III interventional
Design
Randomized

Detailed Description

This randomised, parallel-group trial enrolled inpatients (18–85 years) with severe major depressive disorder who had been offered and accepted ECT to compare IV ketamine with standard ECT.

Experimental treatment consisted of racemic ketamine 0.5 mg/kg infused IV over 40 minutes, administered thrice weekly; the comparator arm received ECT per local standard procedures (anaesthesia and muscle relaxation included).

Primary outcome was remission (MADRS ≤10) after 4 weeks; secondary assessments included response/remission at 3, 6 and 12 months, cognitive testing (CANTAB), and biomarker analyses from blood samples.

Study Protocol

Preparation

sessions

Dosing

12 sessions
40 min each

Integration

sessions

Study Arms & Interventions

Ketamine IV

experimental

Racemic ketamine IV infusions (0.5 mg/kg) administered over 40 minutes, thrice weekly.

Interventions

  • Ketamine0.5 mg/kg
    via IV• thrice weekly• 12 doses total

    Infusion delivered over 40 minutes.

ECT

active comparator

Electroconvulsive therapy given in line with standard procedures (including anaesthesia, muscle relaxation and oxygenation) thrice weekly.

Interventions

  • Compound
    via Other• thrice weekly

    Standard ECT procedure; anaesthetic and stimulation parameters per local practice.

Participants

Ages
18 – 85
Sexes
Male & Female

Inclusion Criteria

  • Aged 18-85
  • Diagnosed with major depressive disorder (MDD, according to DSM-IV)
  • Inpatients who have been offered and have accepted ECT
  • Are eligible to participate
  • Score ≥ 20 Points on Montgomery Åsberg Depression Rating Scale (MADRS)
  • Must be proficient in spoken and written Swedish
  • American Society of Anaesthesiologists physical status classification (ASA) 1-3

Exclusion Criteria

  • Co-morbid conditions that could interfere with the treatment (e.g. primary psychosis)
  • Habitual difficulties to speak, hear, remember or reason
  • Treatment according to LPT (Lagen om psykiatrisk tvångsvård; Compulsory Psychiatric Care Act)
  • On-going or recent (6 months) drug abuse
  • Known allergy to the active substance
  • Pregnant or breastfeeding women
  • Known cardiovascular disease, including angina, acute/chronic congestive heart failure, moderly hypertension or tachyarrhythmia (because exacerbation by sympathomimetic properties of ketamine)
  • Pathological conditions in central nervous system with risk of increased intracranial pressure (increased ICP with ketamine)
  • Glaucoma (increased IOP with ketamine)
  • Porphyria or thyroid disorder (enhanced sympathomimetic properties by ketamine)
  • Ongoing severe infection

Study Details

  • Status
    Completed
  • Phase
    Phase IIPhase III
  • Type
    interventional
  • Design
    Randomized
  • Target Enrollment198 participants
  • Timeline
    Start: 2015-01-02
    End: 2019-01-08
  • Compound
    Ketamine
  • Topic
    Major Depressive Disorder (MDD)

Locations

Department of Psychiatry — Lund, Sweden

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