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Psilocybin as a Treatment for Anorexia Nervosa: A Pilot Study

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ClinicalTrials.gov Identifier: NCT04505189
Recruitment Status : Recruiting
First Posted : August 10, 2020
Last Update Posted : April 19, 2021
Sponsor:
Information provided by (Responsible Party):
Imperial College London

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 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 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
Estimated Study Start Date : May 2021
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : September 2023

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




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.



Information from the National Library of Medicine

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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. >3 years of illness diagnosis
  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 ≥15kg/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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04505189


Contacts
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Contact: Meg J Spriggs, PhD +44 7538223146 panorexia.trial@imperial.ac.uk

Locations
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United Kingdom
Imperial College Hammersmith campus Recruiting
London, United Kingdom, W12 0NN
Contact: Meg Spriggs, Dr       panorexia.trial@imperial.ac.uk   
Sponsors and Collaborators
Imperial College London
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Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT04505189    
Other Study ID Numbers: 19HH5267
First Posted: August 10, 2020    Key Record Dates
Last Update Posted: April 19, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Anorexia
Anorexia Nervosa
Signs and Symptoms, Digestive
Feeding and Eating Disorders
Mental Disorders
Psilocybin
Hallucinogens
Physiological Effects of Drugs
Psychotropic Drugs