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Psilocybin as a Treatment for Anorexia Nervosa: A Pilot Study

Primary Purpose

Anorexia Nervosa

Status

Active

Phase

Phase 1

Locations

United Kingdom

Study Type

Interventional

Intervention

Psilocybin

About this trial

This is an interventional treatment trial for Anorexia Nervosa

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

Current or previously diagnosed psychotic disorder
Immediate family member with a diagnosed psychotic disorder
Unstable physical condition e.g., rapid weight loss > 2kg in the prior month
Abnormal serum electrolytes, raised cardiac enzymes, hepatic or renal dysfunction
MRI or EEG contraindications
A history of laxative abuse in the last 3 months (more than twice a week for 3 months)
History of serious suicide attempts or presence of a suicide/ serious self-harm risk at screening
Currently an involuntary patient
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
Blood or needle phobia
Positive pregnancy test at screening or during the study, or woman who are breastfeeding
If sexually active, participants who lack appropriate contraceptive measures
Drug or alcohol dependence within the last 6 months
No email access
Patients presenting with abnormal QT interval prolongation at screening or with a history of this (QTc at screening above 470ms)
Patients who are currently, or have recently (within 3 months) been enrolled in another CTIMP.

Sites / Locations

Imperial College Hammersmith campus

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

Psilocybin

Outcomes

Primary Outcome Measures

Readiness and Motivation Questionnaire (RMQ)

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)

Decrease in eating disorder psychopathology.

Eating Disorder Examination Questionnaire (EDE-Q)

Decrease in eating disorder psychopathology.

Secondary Outcome Measures

Functional Magnetic Resonance Imaging (fMRI)

Changes in blood oxygen level dependent (BOLD) signal during rest and disorder relevant tasks.

Full Information

NCT ID

NCT04505189

First Posted

July 30, 2020

Last Updated

April 28, 2023

Sponsor

Imperial College London

1. Study Identification

Unique Protocol Identification Number

NCT04505189

Brief Title

Psilocybin as a Treatment for Anorexia Nervosa: A Pilot Study

Official Title

Psilocybin as a Treatment for Anorexia Nervosa: A Pilot Study

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

May 28, 2021 (Actual)

Primary Completion Date

June 2023 (Anticipated)

Study Completion Date

June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Imperial College London

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anorexia Nervosa

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study 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.

Allocation

N/A

Enrollment

21 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment

Arm Type

Experimental

Arm Description

Psilocybin

Intervention Type

Drug

Intervention Name(s)

Psilocybin

Intervention Description

Psilocybin assisted psychotherapy

Primary Outcome Measure Information:

Title

Readiness and Motivation Questionnaire (RMQ)

Description

Increase in readiness and motivation to recover from baseline to primary endpoint, which will be related to long-term improvements in psychopathology.

Time Frame

Baseline - Primary endpoint (6 weeks)

Title

Eating Disorder Examination (EDE)

Description

Decrease in eating disorder psychopathology.

Time Frame

Baseline - Primary endpoint (6 weeks) - 6 month follow-up.

Title

Eating Disorder Examination Questionnaire (EDE-Q)

Description

Decrease in eating disorder psychopathology.

Time Frame

Baseline - Primary endpoint (6 weeks) - 6 month follow-up.

Secondary Outcome Measure Information:

Title

Functional Magnetic Resonance Imaging (fMRI)

Description

Changes in blood oxygen level dependent (BOLD) signal during rest and disorder relevant tasks.

Time Frame

Baseline - Primary endpoint (6 weeks)

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Primary DSM-V diagnosis of Anorexia Nervosa Current diagnosis of Anorexia Nervosa, established by specialist eating disorder care team to have likely been present for >3 years Current or past treatments have not been successful to maintain remission from anorexia Be in the care of a GP and specialist eating disorder team in the UK Have a GP and specialist eating disorder team in the UK who can confirm diagnosis Sufficiently competent in English and mental capacity to provide written informed consent BMI ≥14kg/m2 and medically stable Capacity to consent Agree to have us maintain contact with an identified next-of-kin for the duration of the study Agree to have us maintain contact with GP and/or specialist eating disorder team as required, for the duration of the study Exclusion Criteria: Current or previously diagnosed psychotic disorder Immediate family member with a diagnosed psychotic disorder Unstable physical condition e.g., rapid weight loss > 2kg in the prior month Abnormal serum electrolytes, raised cardiac enzymes, hepatic or renal dysfunction MRI or EEG contraindications A history of laxative abuse in the last 3 months (more than twice a week for 3 months) History of serious suicide attempts or presence of a suicide/ serious self-harm risk at screening Currently an involuntary patient 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 Blood or needle phobia Positive pregnancy test at screening or during the study, or woman who are breastfeeding If sexually active, participants who lack appropriate contraceptive measures Drug or alcohol dependence within the last 6 months No email access Patients presenting with abnormal QT interval prolongation at screening or with a history of this (QTc at screening above 470ms) Patients who are currently, or have recently (within 3 months) been enrolled in another CTIMP.

Facility Information:

Facility Name

Imperial College Hammersmith campus

City

London

ZIP/Postal Code

W12 0NN

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

34744825

Citation

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.

Results Reference

derived

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Psilocybin as a Treatment for Anorexia Nervosa: A Pilot Study

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