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 (26-52mg/70kg) on mood and eating disorder cognitions in enduring anorexia nervosa (AN).

The study consists of two treatment phases: a double-blind single-dose crossover phase and an open-label maintenance phase. In the crossover phase (3 weeks), participants receive single oral doses of ketamine (0.375 mg/kg, 0.75 mg/kg) or midazolam (0.01 mg/kg) weekly. The maintenance phase, for those showing at least 50% improvement, involves open-label oral ketamine 1-2x weekly for 3 months.

The primary outcomes measured using Montgomery Asberg Depression Rating Scale (MADRS), Hamilton Anxiety Scale (HamA), and Yale-Brown-Cornell Eating-Disorder-Examination (YBC-EDE) will assess improvements. EEG abnormalities will also be examined.

The trial, focusing on individuals aged 18-45 with AN of over 5 years’ duration, is registered on ANZCTR (ACTRN12618001393246p). Ethics approval is pending, and recruitment is anticipated to begin in September 2019 at Dunedin, Otago. The University of Otago sponsors the study, led by Prof Paul Glue, aiming to explore ketamine’s potential in treating enduring AN.

Topic Eating Disorders
Compound Ketamine
Country New Zealand
Visit trial
Status Not yet recruiting
Results Published No
Start date 02 September 2019
End date 31 December 2025
Phase Phase II
Design Blinded
Type Interventional
Generation First
Participants 24
Sex All
Age 18- 45
Therapy No

Trial Details

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.

NCT Number ACTRN12618001393246p

Sponsors & Collaborators

University of Otago
The University of Otago (specifically the Dunedin School of Medicine) is associated with psychedelic research but doesn't yet have a full profile.

Data attribution

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