Psilocybin as a Treatment for Anorexia Nervosa: A... — Clinical Trial Details

This pilot interventional study recruits adults with a primary DSM‑5 diagnosis of anorexia nervosa of at least three years’ duration who have not responded to standard treatments; participants receive psilocybin-assisted psychotherapy over three dosing sessions (titrated, maximum single dose 25 mg).

Assessment includes two MRI scans, up to five EEG recordings, psychological measures and interviews across eight study visits, with 12 months of follow-up to evaluate acceptability, efficacy and neural correlates.

Participants

Ages

21 – 65

Sexes

female

BMI

14 - +

Psychosis History

Excluded

Inclusion Criteria

Inclusion Criteria:
1. Primary DSM-V diagnosis of Anorexia Nervosa
2. Current diagnosis of Anorexia Nervosa, established by specialist eating disorder care team to have likely been present for >3 years
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 ≥14kg/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

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.

Company

Product

Legal

Psilocybin as a Treatment for Anorexia Nervosa: A Pilot Study

Detailed Description

Study Protocol

Preparation

Dosing

Locations

Integration

Therapeutic Protocol

Study Arms & Interventions

Psilocybin

Interventions

Participants

Inclusion Criteria

Exclusion Criteria

Study Details

Study Team

Sponsors & Collaborators