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

Tracking Information

• First Submitted Date: July 30, 2020
• First Posted Date: August 10, 2020
• Last Update Posted Date: May 1, 2023
• Actual Study Start Date: May 28, 2021
• Estimated Primary Completion Date: June 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 5, 2020)

• 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.
• Eating Disorder Examination (EDE) [ Time Frame: Baseline - Primary endpoint (6 weeks) - 6 month follow-up. ]
  Decrease in eating disorder psychopathology.
• Eating Disorder Examination Questionnaire (EDE-Q) [ Time Frame: Baseline - Primary endpoint (6 weeks) - 6 month follow-up. ]
  Decrease in eating disorder psychopathology.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: August 5, 2020)

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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Psilocybin as a Treatment for Anorexia Nervosa: A Pilot Study
• Official Title: Psilocybin as a Treatment for Anorexia Nervosa: A Pilot Study
• 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.
• 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 Type: Interventional
• Study Phase: Phase 1; Phase 2

Study Design

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

• Condition: Anorexia Nervosa

Intervention

Drug: Psilocybin

Psilocybin assisted psychotherapy

Study Arms

Experimental: Treatment

Psilocybin

Intervention: Drug: Psilocybin

• Publications *: 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.

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: April 28, 2023): 21
• Original Estimated Enrollment (submitted: August 5, 2020): 20
• Estimated Study Completion Date: June 2024
• Estimated Primary Completion Date: June 2023 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 21 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United Kingdom

Administrative Information

• NCT Number: NCT04505189
• Other Study ID Numbers: 19HH5267
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

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

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Imperial College London
• Original Responsible Party: Same as current
• Current Study Sponsor: Imperial College London
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Imperial College London
• Verification Date: April 2023