Ketamine in anorexia nervosa

Phase 2

Not yet recruiting

• Conditions: anorexia nervosa; depressive disorder; anxiety disorder; obessional disorder; Mental Health - Eating disorders; Mental Health - Depression; Mental Health - Anxiety; Mental Health - Other mental health disorders

• Registration Number: ACTRN12618001393246
• Lead Sponsor: niversity of Otago

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-08-20
• Last Update Posted: 22 July 2019

Recruitment & Eligibility

• Status: Not yet recruiting
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Montgomery Asberg Depression Rating Scale (MADRS), <br><br>[Double-blind crossover phase : predose, 2, 24, 72, & 168h post-each dose <br>Maintenance phase: predose and 2h post-dose.];Hamilton Anxiety Scale (HamA)[Double-blind crossover phase : predose, 2, 24, 72, & 168h post-each dose <br>Maintenance phase: predose and 2h post-dose.];Yale-Brown-Cornell Eating-Disorder-Examination (YBC-EDE) - measuring obsessionality<br>[Double-blind crossover phase : predose, 2, 24, 72, & 168h post-each dose <br>Maintenance phase: predose and 2h post-dose.]

Secondary Outcome Measures

Name	Time	Method
EEG abnormalities have been identified in the cingulate cortex in enduring anorexia nervosa. The 10 minute resting state Electroencephalogram (EEG) is to identify if such changes can be normalised after treatment with ketamine, tPNS and ISF[Double-blind crossover phase : predose, 2, and 24h post-each dose <br>]