The therapeutic potential of psilocybin in anorexia nervosa in young adults

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Region Skane

Participant type

Pediatric, Patients

Age range

0-17 years, 18-64 years

Gender

Male and Female

Therapeutic area

Psychiatry and Psychology [F] - Behavior and Behavior Mechanisms [F01], Psychiatry and Psychology [F] - Mental Disorders [F03], Psychiatry and Psychology [F] - Psychological Phenomena [F02]

Decision date (initial)

2025-06-18

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Norrsken MIND

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Therapy, Safety

To evaluate the safety and tolerability of two doses of psilocybin (25 mg) one month apart, administered with psychological support in young adults (16-35 years) with anorexia nervosa (AN) compared to the standard Treatment as Usual (TAU).

Secondary objectives 4

1. Mechanisms of action of psilocybin through neurobiological assessments and neuroimaging
2. Qualitative analysis of the subjective experiences of the intervention by patients, relatives, and therapists.
3. Time to relapse, response and remission.
4. Changes in psychological self-report measurements.

Conditions and MedDRA coding

Anorexia Nervosa

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Anorexia Nervosa as defined by DSM-5.
2. Age 16-35
3. Ongoing stable contact with an outpatient psychiatric unit.
4. BMI >16.
5. Have experienced at least one period of remission (minimum BMI 17) followed by a relapse.

Exclusion criteria 13

1. Psychosis, bipolar disorder or substance use disorder
2. Blood or needle phobia.
3. Unable to follow study protocol.
4. Presence of metal pieces in the body (contraindicated by fMRI).
5. Family history of psychosis or bipolar disorder.
6. Refusal of birth control during until primary endpoint.
7. Previous use of classical psychedelics
8. Ongoing medications that would interfere negatively with the study drug.
9. Cardiovascular conditions, epilepsy, diabetes mellitus
10. Positive drug tests
11. Suicidal intent.
12. Allergy or intolerance to drug content.
13. Any other clinically significant medical condition that, in the investigator’s opinion, may pose a risk to the participant or interfere with study results.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Incidence of adverse events (AEs) and serious adverse events (SAEs) during the trial period.

Secondary endpoints 12

1. General Anxiety (GAD-2)
2. Patient Health Questionnaire (PHQ-2)
3. Experiences in Close Relationships – (ECR–RS)
4. Life Satisfaction (LS)
5. Positive & Neg Affect (PANAS)
6. Harmony in Life (HILS)
7. Self-compassion (Short SCS)
8. Ten Item Pers Inv (TIPI)
9. AN symptom severity (EDE)
10. Response: A clinically significant improvement in weight and psychological symptoms during the treatment period.
11. Remission: The achievement and maintenance of weight restoration and psychological well-being, with no significant symptoms of anorexia nervosa.
12. Relapse: Defined as a composite outcome during the 6-month follow-up period

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Region Skane

Sponsor organisation

Region Skane

Address

Dockplatsen 26, Malmo S:t Petri Malmo S:t Petri

City

Malmo

Postcode

211 74

Country

Sweden

Scientific contact point

Organisation

Region Skane

Contact name

Pouya Movahed Rad

Public contact point

Organisation

Region Skane

Contact name

Pouya Movahed Rad

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 29 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications