The primary aim of this study is to assess the acceptability and efficacy of treating anorexia nervosa with psilocybin. The secondary aim of this study is to use Magnetic Resonance Imaging (MRI) and Electroencephalography (EEG) to examine the neuronal underpinnings of treatment with psilocybin in this patient group.
Topic Eating Disorders
Compound Psilocybin
Country United Kingdom
Visit trial
Status
Recruiting
Results Published
Start date
01 May 2021
End date
01 September 2023
Chance of happening
100%
Phase
Phase I
Phase II
Design
Open
Type
Interventional
Participants
20
Sex
Female
Age
21- 65
Therapy
Yes
Trial Details
Anorexia nervosa is the most fatal of all psychiatric conditions. With the current paucity of effective pharmacological and psychological treatments, and fewer than half of those diagnosed making a full recovery, there is a great need for new treatment avenues to be explored. For this study, we will recruit patients who have been suffering from a DSM-V diagnosis of anorexia nervosa for 3 years or more, and who have found other forms of treatment ineffective. Over a period of 6 weeks, participants who are deemed eligible at screening will partake in 8 study visits, including three psilocybin dosing sessions with varying doses. The maximum dose of psilocybin a participant will receive in a single session is 25 mg. Across these 8 visits, there will also be 2 MRI scans, up to 5 EEG recordings and a range of psychological measures (questionnaires and interviews). There will be a follow-up period of 12 months following the final study visit.NCT Number NCT04505189
Sponsors & Collaborators
Imperial College LondonThe Centre for Psychedelic Research studies the action (in the brain) and clinical use of psychedelics, with a focus on depression.
Measures Used
Eating Disorder Examination QuestionnaireThe Eating Disorder Examination Questionnaire (EDE-Q) is a self-report questionnaire that has been adapted from the Eating Disorder Examination (EDE).
Eating Disorder Examination Interview
The Eating Disorder Examination Interview (EDE) is a semi-structured interview conducted by a clinician that has been modified to reflect the current DSM-5 diagnosis. The EDE is rated using four subscales; restraint, eating concern, shape concern and weight concern.