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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 : August 25, 2021
Sponsor:
Information provided by (Responsible Party):
Imperial College London

Tracking Information
First Submitted Date  ICMJE July 30, 2020
First Posted Date  ICMJE August 10, 2020
Last Update Posted Date August 25, 2021
Actual Study Start Date  ICMJE May 28, 2021
Estimated Primary Completion Date March 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Psilocybin as a Treatment for Anorexia Nervosa: A Pilot Study
Official Title  ICMJE 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 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE 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  ICMJE Anorexia Nervosa
Intervention  ICMJE Drug: Psilocybin
Psilocybin assisted psychotherapy
Study Arms  ICMJE Experimental: Treatment
Psilocybin
Intervention: Drug: Psilocybin
Publications * Spriggs MJ, Douglass HM, Park RJ, Read T, Danby JL, de Magalhães 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 5, 2020)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2023
Estimated Primary Completion Date March 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 21 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Meg J Spriggs, PhD +44 7538223146 panorexia.trial@imperial.ac.uk
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04505189
Other Study ID Numbers  ICMJE 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  ICMJE
Plan to Share IPD: No
Responsible Party Imperial College London
Study Sponsor  ICMJE Imperial College London
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Imperial College London
Verification Date August 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP