Psilocybin as a Treatment for Anorexia Nervosa: A Pilot Study

• Status: Recruiting
• Trial end date: 2023-09-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Imperial College London
• Treatments: Psilocybin

Criteria

Inclusion Criteria:

1. Primary DSM-V diagnosis of Anorexia Nervosa

2. >3 years of illness diagnosis

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 ≥15kg/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:

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.