- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04505189
Psilocybin as a Treatment for Anorexia Nervosa: A Pilot Study
April 28, 2023 updated by: Imperial College London
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
21
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Hannah M Douglass
- Phone Number: 07727247277
- Email: panorexia.trial@imperial.ac.uk
Study Locations
-
-
-
London, United Kingdom, W12 0NN
- Imperial College Hammersmith Campus
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 63 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment
Psilocybin
|
Psilocybin assisted psychotherapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline - Primary endpoint (6 weeks)
|
Eating Disorder Examination (EDE)
Time Frame: Baseline - Primary endpoint (6 weeks) - 6 month follow-up.
|
Decrease in eating disorder psychopathology.
|
Baseline - Primary endpoint (6 weeks) - 6 month follow-up.
|
Eating Disorder Examination Questionnaire (EDE-Q)
Time Frame: Baseline - Primary endpoint (6 weeks) - 6 month follow-up.
|
Decrease in eating disorder psychopathology.
|
Baseline - Primary endpoint (6 weeks) - 6 month follow-up.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline - Primary endpoint (6 weeks)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 28, 2021
Primary Completion (Anticipated)
June 1, 2023
Study Completion (Anticipated)
June 1, 2024
Study Registration Dates
First Submitted
July 30, 2020
First Submitted That Met QC Criteria
August 5, 2020
First Posted (Actual)
August 10, 2020
Study Record Updates
Last Update Posted (Actual)
May 1, 2023
Last Update Submitted That Met QC Criteria
April 28, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19HH5267
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Anorexia Nervosa
-
Rosemary Claire RodenChildren's Miracle NetworkEnrolling by invitationBulimia Nervosa | Impulsive Behavior | Purging (Eating Disorders) | Eating Disorders | Eating Disorders in Adolescence | Anorexia Nervosa/Bulimia | Anorexia in Adolescence | Anorexia Nervosa, Atypical | Anorexia Nervosa, Binge Eating/Purging TypeUnited States
-
Fundació Institut de Recerca de l'Hospital de la...Fundació La Marató de TV3RecruitingAnorexia Nervosa | Anorexia Nervosa in Remission | Anorexia Nervosa Restricting TypeSpain
-
Duke UniversityCompletedAdolescent Anorexia Nervosa | Subthreshold Anorexia NervosaUnited States
-
University of California, San DiegoRecruitingAnorexia Nervosa | Bulimia Nervosa | Atypical Anorexia Nervosa | Atypical Bulimia NervosaUnited States
-
Stanford UniversityNational Institute of Mental Health (NIMH); National Institutes of Health (NIH) and other collaboratorsCompletedAnorexia Nervosa | Anorexia | Eating Disorder | Eating Disorders in Adolescence | Anorexia in Adolescence | Anorexia Nervosa, Atypical | Anorexia Nervosa Restricting Type | Anorexia in ChildrenUnited States
-
Linnaeus UniversityGöteborg University; Linkoeping UniversityRecruitingBulimia Nervosa | Major Depression | Anorexia Nervosa/BulimiaSweden
-
Umeå UniversityActive, not recruitingAnorexia Nervosa | Anorexia in Adolescence | Anorexia Nervosa, AtypicalSweden
-
Yeshiva UniversityYale UniversityRecruitingAnorexia Nervosa | Bulimia Nervosa | Anorexia Nervosa, Atypical | Bulimia; AtypicalUnited States
-
The Miriam HospitalUnknownEating Disorders in Adolescence | Anorexia Nervosa/Bulimia | Anorexia Nervosa Restricting TypeUnited States
-
University of California, San DiegoRecruitingAnorexia Nervosa | Atypical Anorexia NervosaUnited States
Clinical Trials on Psilocybin
-
Yale UniversityHeffter Research Institute; Ceruvia Lifesciences; CH TAC LLCCompleted
-
University of Wisconsin, MadisonTRYP TherapeuticsWithdrawn
-
Yale UniversityCeruvia LifesciencesCompleted
-
King's College LondonUniversity of CambridgeRecruitingAutism Spectrum DisorderUnited Kingdom
-
Section for Affective Disorders; Northern Stockholm...Karolinska Institutet; Vastra Gotaland Region; Region Örebro County; Uppsala University...Not yet recruiting
-
Yale UniversityHeffter Research InstituteActive, not recruitingMajor Depressive DisorderUnited States
-
University Health Network, TorontoCentre for Addiction and Mental HealthRecruitingDepression | Mood Disorders | Major Depressive Disorder | Treatment-Resistant DepressionCanada
-
Yale UniversityTerminated
-
Multidisciplinary Association for Psychedelic StudiesWithdrawnAnxiety | Stage IV MelanomaUnited States
-
University of Colorado, DenverNot yet recruitingAnhedonia | Major Depressive Disorder | Treatment Resistant DepressionUnited States