Anorexia NervosaPhase 1/2NCT04505189
Psilocybin as a Treatment for Anorexia Nervosa: A Pilot Study
A Phase 1/2 study testing Psilocybin in people with Anorexia Nervosa, run by Imperial College London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 65 years, women only
- Conditions the study is for
- Anorexia Nervosa
- What is being tested?
- Psilocybin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 28 May 2021to 12 Jun 2024
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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)
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- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Imperial College Hammersmith campus
London, W12 0NN
About this study
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.
Read the 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.
- Conditions
- Anorexia Nervosa
- Being tested
- Psilocybin
- Medical subject headings
- Anorexia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsilocybinDrug
Psilocybin assisted psychotherapy
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Psilocybin Receives: Drug: Psilocybin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline - Primary endpoint (6 weeks)
Eating Disorder Examination (EDE)
Decrease in eating disorder psychopathology.
Measured: Baseline - Primary endpoint (6 weeks) - 6 month follow-up.
Eating Disorder Examination Questionnaire (EDE-Q)
Decrease in eating disorder psychopathology.
Measured: Baseline - Primary endpoint (6 weeks) - 6 month follow-up.
Secondary outcomes (1)
Functional Magnetic Resonance Imaging (fMRI)
Changes in blood oxygen level dependent (BOLD) signal during rest and disorder relevant tasks.
Measured: Baseline - Primary endpoint (6 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2020
- Study start28 May 2021
- Primary completion11 Dec 2023
- Study completion12 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04505189
- Sponsor's protocol ID
- 19HH5267
- Status last verified
- Jun 2024
- First submitted
- 30 Jul 2020
- Last updated
- 17 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34744825
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psilocybin as a Treatment for Anorexia Nervosa: A Pilot Study
- ClinicalTrials.gov ID
- NCT04505189
- Acronym / sponsor ID
- 19HH5267
- Conditions
- Anorexia Nervosa
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- 28 May 2021 (actual)
- Primary completion
- 11 Dec 2023 (actual)
- Study completion
- 12 Jun 2024 (actual)
- First posted
- 10 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: PsilocybinPsilocybin |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PsilocybinPsilocybin assisted psychotherapy | Drug | Treatment |
Primary outcome
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.
1 secondary outcome
Functional Magnetic Resonance Imaging (fMRI)
Time frame: Baseline - Primary endpoint (6 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2024.
- Derived from this study: PubMed 34744825Spriggs 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Psilocybin in people with Anorexia Nervosa, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Readiness and Motivation Questionnaire (RMQ) (time frame: Baseline - Primary endpoint (6 weeks)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04505189, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2024.