Psilocybin as a treatment for anorexia nervosa

Recruitment & Eligibility

Status: Completed

Sex: Female

Target Recruitment: 21

Inclusion Criteria

Current inclusion criteria as of 08/11/2022:

1. DSM-V primary 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
4. 21 - 65 years old
5. Female
6. Be in the care of a specialist eating disorder team in the UK
7. Have a GP and/or specialist eating disorder team in the UK who can confirm diagnosis
8. Sufficiently competent in English and mental capacity to provide written informed consent
9. BMI >14kg/m² and medically stable
10. Capacity to consent
11. Agree to have us maintain contact with an identified next-of-kin for the duration of the study
12. Agree to have us maintain contact with their specialist eating disorder team/care team as required for the duration of the study

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Previous inclusion criteria:

1. DSM-V diagnosis of Anorexia Nervosa
2. >3 years of illness diagnosis
3. Current or past treatments have not been successful to maintain remission
4. 21 - 65 years old
5. Female
6. Be in the care of a specialist eating disorder team in the UK
7. Have a GP and/or specialist eating disorder team in the UK who can confirm diagnosis
8. Sufficiently competent in English and mental capacity to provide written informed consent
9. BMI >15kg/m² and medically stable
10. Capacity to consent
11. Agree to have us maintain contact with an identified next-of-kin for the duration of the study
12. Agree to have us maintain contact with their specialist eating disorder team/care 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. Medical condition that is unsuitable for the EEG components of the study (e.g., epilepsy, severe migraine)
6. Other physical conditions that are unsuitable for the psychedelic component of the study (e.g., diabetes, epilepsy, severe cardiovascular disease, hepatic or renal failure e.g., CrCl < 30ml/min etc.)
7. MRI contraindications
8. Have a history of laxative abuse in the last 3 months (defined as laxative use more than twice a week for 3 months)
9. History of serious suicide attempts or presence of a suicide/ serious self-harm risk at screening
10. Currently an involuntary patient
11. Significant history of mania (determined by study psychiatrist and medical records)
12. Emotionally unstable personality, or other psychiatric problem that the screening clinician feels may jeopardize the therapeutic alliance and/or safe exposure to psilocybin
13. Blood or needle phobia
14. Positive pregnancy test at screening or during the study, or woman who are breastfeeding
15. If sexually active, participants who lack appropriate contraceptive measures
16. Drug or alcohol dependence within the last 6 months
17. No email access
18. Patients presenting with abnormal QT interval prolongation at screening or with a history of this (QTc at screening above 470ms)
19. Patients who are currently, or have recently (within 6 months) been enrolled in another CTIMP

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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