Psilocybin as a Treatment for Anorexia Nervosa: A Pilot Study

• ClinicalTrials.gov Identifier: NCT04505189
• Recruitment Status: Active, not recruiting
• First Posted: August 10, 2020
• Last Update Posted: May 1, 2023
• Sponsor: Imperial College London
• Information provided by (Responsible Party): Imperial College London

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Anorexia Nervosa	Drug: Psilocybin	Phase 1; Phase 2

Detailed Description:

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 a primary diagnosis of anorexia nervosa as defined by DSM-V criteria, which has been established by their specialist ED team to have been present for at least 3 years, 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 21 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Masking Description: All participants will receive 3 doses of psilocybin. The maximum dose a participant will receive in a single session is 25 mg.
• Primary Purpose: Treatment
• Official Title: Psilocybin as a Treatment for Anorexia Nervosa: A Pilot Study
• Actual Study Start Date: May 28, 2021
• Estimated Primary Completion Date: June 2023
• Estimated Study Completion Date: June 2024

Arms and Interventions

Arm	Intervention/treatment
Experimental: Treatment; Psilocybin	Drug: Psilocybin; Psilocybin assisted psychotherapy

Outcome Measures

Primary Outcome Measures :

1. Readiness and Motivation Questionnaire (RMQ) [ Time Frame: Baseline - Primary endpoint (6 weeks) ]
   Increase in readiness and motivation to recover from baseline to primary endpoint, which will be related to long-term improvements in psychopathology.
2. Eating Disorder Examination (EDE) [ Time Frame: Baseline - Primary endpoint (6 weeks) - 6 month follow-up. ]
   Decrease in eating disorder psychopathology.
3. Eating Disorder Examination Questionnaire (EDE-Q) [ Time Frame: Baseline - Primary endpoint (6 weeks) - 6 month follow-up. ]
   Decrease in eating disorder psychopathology.

Secondary Outcome Measures :

1. Functional Magnetic Resonance Imaging (fMRI) [ Time Frame: Baseline - Primary endpoint (6 weeks) ]
   Changes in blood oxygen level dependent (BOLD) signal during rest and disorder relevant tasks.

Eligibility Criteria

• Ages Eligible for Study: 21 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. Primary DSM-V diagnosis of Anorexia Nervosa
2. Current diagnosis of Anorexia Nervosa, established by specialist eating disorder care team to have likely been present for >3 years
3. Current or past treatments have not been successful to maintain remission from anorexia
4. Be in the care of a GP and specialist eating disorder team in the UK
5. Have a GP and specialist eating disorder team in the UK who can confirm diagnosis
6. Sufficiently competent in English and mental capacity to provide written informed consent
7. BMI ≥14kg/m2 and medically stable
8. Capacity to consent
9. Agree to have us maintain contact with an identified next-of-kin for the duration of the study
10. Agree to have us maintain contact with GP and/or specialist eating disorder team as required, for the duration of the study

Exclusion Criteria:

1. Current or previously diagnosed psychotic disorder
2. Immediate family member with a diagnosed psychotic disorder
3. Unstable physical condition e.g., rapid weight loss > 2kg in the prior month
4. Abnormal serum electrolytes, raised cardiac enzymes, hepatic or renal dysfunction
5. MRI or EEG contraindications
6. A history of laxative abuse in the last 3 months (more than twice a week for 3 months)
7. History of serious suicide attempts or presence of a suicide/ serious self-harm risk at screening
8. Currently an involuntary patient
9. Emotionally unstable personality, history of mania, or other psychiatric problem that the screening clinician feels may jeopardise the therapeutic alliance and/or safe exposure to psilocybin
10. Blood or needle phobia
11. Positive pregnancy test at screening or during the study, or woman who are breastfeeding
12. If sexually active, participants who lack appropriate contraceptive measures
13. Drug or alcohol dependence within the last 6 months
14. No email access
15. Patients presenting with abnormal QT interval prolongation at screening or with a history of this (QTc at screening above 470ms)
16. Patients who are currently, or have recently (within 3 months) been enrolled in another CTIMP.

Contacts and Locations

Locations

United Kingdom

Imperial College Hammersmith campus

London, United Kingdom, W12 0NN

Sponsors and Collaborators

Imperial College London

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Spriggs MJ, Douglass HM, Park RJ, Read T, Danby JL, de Magalhaes FJC, Alderton KL, Williams TM, Blemings A, Lafrance A, Nicholls DE, Erritzoe D, Nutt DJ, Carhart-Harris RL. Study Protocol for "Psilocybin as a Treatment for Anorexia Nervosa: A Pilot Study". Front Psychiatry. 2021 Oct 20;12:735523. doi: 10.3389/fpsyt.2021.735523. eCollection 2021.

• Responsible Party: Imperial College London
• ClinicalTrials.gov Identifier: NCT04505189
• Other Study ID Numbers: 19HH5267
• First Posted: August 10, 2020
• Last Update Posted: May 1, 2023
• Last Verified: April 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Anorexia; Anorexia Nervosa; Signs and Symptoms, Digestive; Feeding and Eating Disorders; Mental Disorders; Psilocybin; Hallucinogens; Physiological Effects of Drugs; Psychotropic Drugs