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CompletedPhase 1 / Phase 2

Psilocybin as a Treatment for Anorexia Nervosa: A Pilot Study

NCT04505189 · Imperial College London

Closed to entry
Status
Not accepting participants
Phase 1 / Phase 2
Phase
21
Target enrolment
1
Study sites
Outside the US

What it is testing

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Readiness and Motivation Questionnaire (RMQ)

    Measured over Baseline - Primary endpoint (6 weeks)

  • Eating Disorder Examination (EDE)

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

  • Eating Disorder Examination Questionnaire (EDE-Q)

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

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

21 Years to 65 Years
Ages
FEMALE
Sex
Not accepted
Healthy volunteers
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.

Where

1 study site

FacilityCityRegionCountry
Imperial College Hammersmith campusLondonUnited Kingdom

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT04505189 on ClinicalTrials.gov →

Last updated in the registry 2024-06-17. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits