Clinical TrialEating DisordersKetamineKetaminePlaceboKetamineNot yet recruiting

Pilot study on the effects of ketamine on mood and eating disorder cognitions in enduring anorexia nervosa

This interventional trial (n=24) investigates the effects of ketamine (26–52 mg/70 kg) on mood and eating-disorder cognitions in enduring anorexia nervosa (AN).

Target Enrollment
24 participants
Study Type
Phase II interventional
Design
Randomized, double Blind

Detailed Description

Randomised, double-blind, balanced crossover Phase II study (n=24) with three weekly single oral doses: ketamine 0.375 mg/kg, ketamine 0.75 mg/kg, and midazolam 0.01 mg/kg; responders (≥50% improvement on mood/anxiety ratings) may enter a 3-month open-label maintenance phase of oral ketamine 1–2× weekly.

Outcomes include mood and eating-disorder cognitions (MADRS and related instruments), 10-minute resting EEG pre/post treatment, and safety assessments performed predose, 2 hours and 24 hours after each dose.

Study Protocol

Preparation

sessions

Dosing

3 sessions

Integration

sessions

Study Arms & Interventions

Crossover ketamine/midazolam

experimental

Double-blind balanced crossover: ketamine 0.375 mg/kg, ketamine 0.75 mg/kg, midazolam 0.01 mg/kg; weekly for 3 weeks; responders may enter open-label maintenance.

Interventions

  • Ketamine0.375 mg/kg
    via Oral• single dose• 1 doses total

    Single oral dose in crossover phase.

  • Ketamine0.75 mg/kg
    via Oral• single dose• 1 doses total

    Single oral dose in crossover phase.

  • Placebo0.01 mg/kg
    via Oral• single dose• 1 doses total

    Active comparator (midazolam) used as blinded control.

  • Ketamine
    via Oral• 1-2x weekly

    Maintenance phase: open-label oral ketamine 1–2× weekly for 3 months for responders; dose optimised from crossover phase.

Participants

Ages
18 – 45
Sexes
Male & Female

Inclusion Criteria

  • Primary diagnosis DSM-5 Anorexia Nervosa (AN) based on a structured psychiatric interview
  • Illness duration of AN >5 years
  • Disabling severity with substantial functional impairment
  • AN treatment refractoriness (lack of response to two or more typical modes of treatment such as inpatient weight restoration, psychotherapy and/or psychopharmacology)
  • Severely underweight: BMI greater than 15 and less than 18
  • 18–45 years old
  • English speaking and able to answer study questions fluently
  • Has capacity to provide written informed consent

Exclusion Criteria

  • Unstable physical condition (severe electrolyte disturbances, cardiac failure and other physical conditions due to low weight in which surgery/anaesthesia is contraindicated)
  • Treatable underlying cause of AN/underweight
  • Parkinson's disease, dementia, epilepsy
  • History of schizophrenia/psychosis or bipolar disorder
  • Actively suicidal - Columbia Suicide Severity Rating Scale (CSSRS) score of 4 or 5
  • Alcohol or substance abuse (including benzodiazepines) during the last 6 months
  • Severe DSM-5 Antisocial Personality Disorder or Borderline Personality Disorder
  • Females who are pregnant or lactating

Study Details

Locations

Unknown facility — Australia

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