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    Summary
    EudraCT Number:2019-004054-28
    Sponsor's Protocol Code Number:Panorexia
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2020-04-20
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2019-004054-28
    A.3Full title of the trial
    Psilocybin as a Treatment for Anorexia Nervosa: A Pilot Study
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Psilocybin as a Treatment for Anorexia Nervosa: A Pilot Study
    A.3.2Name or abbreviated title of the trial where available
    Panorexia V1
    A.4.1Sponsor's protocol code numberPanorexia
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorImperial College London
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationImperial College London
    B.5.2Functional name of contact pointCarhart-Harris
    B.5.3 Address:
    B.5.3.1Street AddressBurlington Danes Building
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeW12 0NN
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number02075946550
    B.5.5Fax number02075946548
    B.5.6E-mailr.carhart-harris@imperial.ac.uk
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namePsilocybin
    D.3.2Product code NA
    D.3.4Pharmaceutical form Capsule, soft
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPsilocybin
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number25
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, soft
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Anorexia Nervosa
    E.1.1.1Medical condition in easily understood language
    Anorexia Nervosa
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Mental Disorders [F03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10002646
    E.1.2Term Anorexia
    E.1.2System Organ Class 100000004861
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10002649
    E.1.2Term Anorexia nervosa
    E.1.2System Organ Class 10037175 - Psychiatric disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary aim of the study is to assess the efficacy and feasibility of psilocybin in the treatment of Anorexia Nervosa.
    E.2.2Secondary objectives of the trial
    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.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Next-Of-Kin study-
    Version 1, Date, 18/02/2020

    As well as asking that we are in contact with patients’ next of kin/significant other throughout the trial, we will also ask for their ratings of the patient's eating disorder symptoms both via a brief questionnaire and a semi-structured interview. The questionnaire will be sent to participants via email both before the patient begins the trial (between screening and baseline) and 2 weeks after the final dosing session, corresponding to the patient’s follow-up visit. The Next-Of-Kin Questionnaire is a short questionnaire comprised of Likert scales that will be quick to complete. The interview will be performed approximately 2 weeks after the final dosing session. With consent from the participant (the next-of-kin), these interviews will be audio recorded. Patients and their next-of-kin will be made aware that although contact with the next-of-kin is required as part of the trial, participation in the next-of-kin study (i.e., the questionnaire and interview) are not.

    The procedures for obtaining an assessment from a significant other will be as follows: at screening, the patient will be asked if they consent to us contacting their next-of-kin (a relevant item is included in the consent form). We will ask for the name and email address of their next-of-kin. We will contact this person by email to explain that they have been identified as the participant’s next-of-kin and that we ask for their involvement in two ways. Firstly, as part of the trial we will maintain contact with them throughout. In addition, we will inform them that we are recruiting for a study involving a questionnaire (to be filled in twice) and an interview. Through the interview and the questionnaire, we will ask about a person they know who is in one of our trials. At the same time, they will be sent an information sheet and consent form to consider. Consent for the first part of this study (contact throughout the trial) is mandatory for the participant to take part in the clinical trial. Consent for the second part (to fill out the questionnaires and take part in the interview) is optional. Once they have completed the consent form and returned it to us, we will send the pre-study questionnaire to those who consent. We will explain that we will contact them via email at some point in the next six months to complete another rating.

    E.3Principal 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
    E.4Principal 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.

    E.5 End points
    E.5.1Primary end point(s)
    Eating Disorder Examination interview and questionnaire
    Readiness and Motivation Questionnaire
    E.5.1.1Timepoint(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.
    E.5.2Secondary 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 Selected items from the 44-item Big Five Inventory
    o The Centrality of events scale (short version)^*
    o Single item assessing meaning making^*

    Behavioural measures
    o Leeds Oxford Food Preference Questionnaire/ task
    o Disorder specific tasks

    Measures completed around dosing days
    The following measures will be completed either prior to treatment either the day before dosing, or on dosing day 1, 2 and 3 or following treatment on the dosing or integration days:
    o The Readiness and Motivation Questionnaire (RMQ)
    o Eating Disorder Examination Questionnaire (EDE-Q)
    o The Pros and Cons of Anorexia scale (P-CAN)
    o Multidimensional Psychological Flexibility Inventory (MPFI)
    o Spielberger’s Trait Anxiety Inventory (STAI) - State
    o The Psychedelic Predictor Scale (self-constructed)
    o Mystical Experience Questionnaire (MEQ)
    o 11 Dimension Altered States of Consciousness Scale (11D ASC)
    o Visual Analogue Scales (VAS)
    o Geneva Emotional Music Scales (GEMS)
    o The Challenging Experience Questionnaire (CEQ)
    o The Emotional Breakthrough Inventory (EBI)
    o The Imperial Overview item
    o Therapeutic Music Experience Questionnaire (TMEQ, self-constructed)
    o Setting Questionnaire (SQ, self-constructed)
    o Relaxed Beliefs Under Psychedelics Questionnaire (REBUS-Q self-constructed)
    o Experiential Avoidance Questionnaire
    o Scale To Assess the Therapeutic Relationship (STAR)
    o Psychological Insight Scale (PIS, self-constructed)
    Additionally, on dosing days participants will be asked to wear an Empatica E4 wristband to record physiological measurements.

    With prior consent, we will also send the patient’s next-of-kin short questionnaires at baseline and at end point to enquire how they perceive the patient’s eating disorder symptoms and whether they have noticed any changes in the patient’s behaviour since the intervention (Section 14).

    Neurophysiological/imaging measures
    MRI measures will include:
    o Anatomical scans such as T1, T2, ASL and diffusion
    o Resting state blood oxygen level dependent (BOLD) signal
    o Task-based BOLD responses
    The EEG measures will include:
    o Resting state
    o Visual Long-Term Potentiation task60
    o Perceptual task

    Additional weekly measures will include the weekly QIDS-16, and an eating habits questionnaire (self-constructed).
    As this is a feasibility study, we will also be recording recruitment rate and retention rate.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Unless otherwise specified, psychological measures will be collected at baseline and/or at 6 weeks follow-up (primary end point).

    MRI measures will be collected at baseline and at the 6 week follow-up (primary end point).
    EEG measures will be compared between baseline, on integration days, and the 6 week follow-up (primary end point).

    Weekly measures will be collected once a week from screening to the 4 week follow-up (primary end point).
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind Yes
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    within subject, single arm
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The last follow-up phone call and remote questionnaire (up to 12 months after the last study visit) will constitute the end of the study for the last participant.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days3
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days3
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 20
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 20
    F.4.2.2In the whole clinical trial 20
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Outside of the study, patients will be treated as usual. Patients will continue working with their usual care providers. If a patient was on antidepressant or serotonergic medication prior to commencing the trial, they may wish to return to taking this medication.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation NA
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-06-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-06-23
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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