Psilocybin as a Treatment for Anorexia Nervosa: A Pilot Study

NCT04505189 | Completed Phase 1

• 1 other identifier: 19HH5267
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Anorexia Nervosa

Outcome Measures

Primary Outcomes (3)

• 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.

  Baseline - Primary endpoint (6 weeks)

• Eating Disorder Examination (EDE)

  Decrease in eating disorder psychopathology.

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

• Eating Disorder Examination Questionnaire (EDE-Q)

  Decrease in eating disorder psychopathology.

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

Secondary Outcomes (1)

• Functional Magnetic Resonance Imaging (fMRI)

  Baseline - Primary endpoint (6 weeks)

Study Arms (1)

Treatment

EXPERIMENTAL

Psilocybin

Drug: Psilocybin

Interventions

Psilocybin DRUG

Psilocybin assisted psychotherapy

Treatment

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (1)

Imperial College Hammersmith campus

London, W12 0NN, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 34744825 DERIVED

MeSH Terms

Conditions

Anorexia Nervosa

Interventions

Psilocybin

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Tryptamines; Indolizidines; Indolizines

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: All participants will receive 3 doses of psilocybin. The maximum dose a participant will receive in a single session is 25 mg.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2020
• First Posted: August 10, 2020
• Study Start: May 28, 2021
• Primary Completion: December 11, 2023
• Study Completion: June 12, 2024
• Last Updated: June 17, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)