None listed
Conditions
Brief summary
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.
Interventions
There are two treatment phases, an initial double-blind single dose crossover phase, and a subsequent open-label maintenance phase. All treatments/interventions will be undertaken in research treatment rooms and patients will be under direct observation of study staff.
Double-blind crossover phase (3 weeks) Patients will receive single oral doses of ketamine 0.375 mg/kg of bodyweight, ketamine 0.75 mg/kg or midazolam 0.01 mg/kg (1 dose of each) weekly over three weeks. The drugs will be admini
There are two treatment phases, an initial double-blind single dose crossover phase, and a subsequent open-label maintenance phase. All treatments/interventions will be undertaken in research treatment rooms and patients will be under direct observation of study staff. Double-blind crossover phase (3 weeks) Patients will receive single oral doses of ketamine 0.375 mg/kg of bodyweight, ketamine 0.75 mg/kg or midazolam 0.01 mg/kg (1 dose of each) weekly over three weeks. The drugs will be administered orally. Dosing will be double blind with a balanced crossover. Maintenance phase: patients completing the double-blind crossover phase, who have shown at least 50% improvement in depression or anxiety ratings will be eligible to enter a 3 month maintenance phase. Oral ketamine will be administered 1-2x weekly (based on durability of improvement in mood/obsessionality), using an optimised dose based on the earlier phase.
Sponsors
University of Otago
Study design
Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver)
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Healthy volunteers
No
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
Outcome results
None listed