Clinical TrialDepressive DisordersKetamineMidalozamNot yet recruiting

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

This randomised controlled Phase II trial (n=24) evaluated the safety and efficacy of ketamine for anorexia nervosa depressive disorder anxiety disorder obessional disorder using 26mg/70kg ketamine.

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

Detailed Description

We will investigate if patients with long-standing anorexia nervosa show improvements in mood, obsessionality ratings, or eating disorder cognitions after oral dosing with ketamine or midazolam, a psychoactive control. In the first 3 weeks, patient will receive one of 2 doses of ketamine, or a single dose of midazolam, under double-blind, crossover conditions. Patient who report improvements in depression or anxiety ratings will be eligible to enter a maintenance treatment phase, where they can receive oral ketamine 1-2 times weekly for 3 months.

Study Arms & Interventions

Experimental Arm

experimental

Interventions

  • Ketamine
  • Midalozam

Participants

Inclusion Criteria

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

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, bipolar disorder
  • Actively suicidal - Columbia Suicide Severity Rating Scale (CSSRS) 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

  • Status
    Not yet recruiting
  • Phase
    Phase II
  • Type
    interventional
  • Design
    Randomizeddouble Blind
  • Target Enrollment24 participants
  • Timeline
    Start: 2019-09-02
  • Compounds
    KetamineMidalozam
  • Topic
    Depressive Disorders

Locations

Unknown facility — Australia

Your Library