Anorexia Nervosa MedDRA version: 20.0 Level: LLT Classification code 10002646 Term: Anorexia System Organ Class: 100000004861 MedDRA version: 20.0 Level: PT Classification code 10002649 Term: Anorexia nervosa System Organ Class: 10037175 - Psychiatric disorders
Conditions
Interventions
Product Name: Psilocybin
Product Code: NA
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: Psilocybin
Concentration unit: mg milligram(s)
Concentration type: up to
Concentration number: 25-
Pha
Sponsors
Imperial College London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • DSM-V diagnosis of Anorexia Nervosa • >3 years of illness diagnosis • Current or past treatments have not been successful to maintain remission • 21-65 years old • Female • Be in the care of a specialist eating disorder team in the UK • Have a GP and/or specialist eating disorder team in the UK who can confirm diagnosis • Sufficiently competent in English and mental capacity to provide written informed consent • BMI >15kg/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 their specialist eating disorder team/care team as required for the duration of the study Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: • 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 • Medical condition that is unsuitable for the EEG components of the study (e.g., epilepsy, severe migraine) • 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) • MRI contraindications • Have a history of laxative abuse in the last 3 months (defined as laxative use 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 • Significant history of mania (determined by study psychiatrist and medical records) • Emotionally unstable personality, or other psychiatric problem that the screening clinician feels may jeopardize 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 6 months) been enrolled in another CTIMP.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary aim of the study is to assess the efficacy and feasibility of psilocybin in the treatment of Anorexia Nervosa. ;Secondary Objective: As a secondary aim, we wish to use Magnetic Resonance Imaging (MRI) and electroencephalography (EEG) to examine the neuronal underpinnings of treatment with psilocybin in this patient group. ;Primary end point(s): Eating Disorder Examination interview and questionnaire Readiness and Motivation Questionnaire ;Timepoint(s) of evaluation of this end point: The EDE will be measured at baseline and at the primary endpoint (6 weeks later). It will then be assessed 6 months after the final study visit. The EDE-Q and RMQ will be assessed at baseline and every 2 weeks until primary endpoint. They will then be assessed monthly for 6 months after the final study visit, and again at 12 months post the final study visit. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Measures collected at baseline and primary end-point Measures followed by a ^ will only be completed at primary end-point. Measures followed by a * will also be completed monthly for 6 months and at 12 months following the final study visit. Structured interviews and self-report questionnaires completed in person or over the phone: o Eating Disorder Examination (EDE)* o Yale-Brown Cornell Eating Disorder Scale Self Report Questionnaire (YBC-EDS-SRQ) o Yale-Brown Cornell Eating Disorder Scale (Y-BCEDS) o Relaxed Beliefs Under Psychedelics Questionnaire (REBUS-Q self-constructed) o Adverse Childhood Experience Questionnaire (ACE) Self-report questionnaires completed remotely: o Eating Disorder Examination Questionnaire (EDE-Q)* o Readiness and Motivation Questionnaire (RMQ)* o The Pros and Cons of Anorexia scale (P-CAN)* o Self-Starvation Scale (SS) o Clinical Impairment Assessment (CIA)* o Snaith-Hamilton Pleasure Scale (SHAPS) o Ruminative Response Scale for Eating Disorders (RRS-ED) o Warwick-Edinburgh Mental Well-being Scale (WEMWBS) o State Trait Anxiety Inventory- Trait (STAI) o Quick Inventory of Depressive Symptomology 16 item (QIDS)* o Flourishing Scale (FS-8) o Modified Tellegen Absorption Questionnaire (MODTAS) o Credibility/Expectancy Questionnaire o Self-esteem: Rosenberg Self-Esteem Scale [4-items] (RSE) o Psychological Insight Scale (PIS, self-constructed)^ o Selected Items from the Absorption in Music Scale (AIMS - revised) o Intolerance of Uncertainty Scale o Watts Connecteness Scale (self-constructed) o Experiential Avoidance Questionnaire o The Exercise Habits Questionnaire (self-constructed) o The Eating Habits Questionnaire (self-constructed) o The Compulsive Exercise Test o Multidimensional Psychological Flexibility Inventory (MPFI) o Meaning in Life Questionnaire (MLQ) o 2-item Sexual Perceptions Questionnaire (SPQ, self-constructed) o Selected items from the Self-Report Assessment of Female Sexual Function o Se | — |
Countries
United Kingdom
Contacts
Public ContactCarhart-Harris
Imperial College London
Outcome results
None listed