Status:
COMPLETED
Psilocybin as a Treatment for Anorexia Nervosa: A Pilot Study
Lead Sponsor:
Imperial College London
Conditions:
Anorexia Nervosa
Eligibility:
FEMALE
21-65 years
Phase:
PHASE1
PHASE2
Brief 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 E...
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 fu...
Eligibility Criteria
Inclusion
- 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
- 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
Exclusion
- 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)
- 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.
Key Trial Info
Start Date :
May 28 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 12 2024
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT04505189
Start Date
May 28 2021
End Date
June 12 2024
Last Update
June 17 2024
Active Locations (1)
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1
Imperial College Hammersmith campus
London, United Kingdom, W12 0NN