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    Summary
    EudraCT Number:2017-000219-18
    Sponsor's Protocol Code Number:PsiloRCT001
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-06-22
    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 number2017-000219-18
    A.3Full title of the trial
    Psilocybin vs. escitalopram for major depressive disorder: comparative mechanisms
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Assessing psilocybin as a treatment for depression
    A.3.2Name or abbreviated title of the trial where available
    Psilodep-RCT
    A.4.1Sponsor's protocol code numberPsiloRCT001
    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 supportThe Alexander Mosely Charitable Trust
    B.4.2CountryUnited Kingdom
    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, Robin
    B.5.3 Address:
    B.5.3.1Street AddressNeuropsychopharmacology Unit,
    B.5.3.2Town/ cityBurlington Danes Building,
    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.3.9.1CAS number 520-52-5
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    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) No
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Yes
    D.2.1.1.1Trade name Escitalopram film-coated tablets
    D.2.1.1.2Name of the Marketing Authorisation holderMilpharm Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameEscitalopram film-coated tablets
    D.3.4Pharmaceutical form Capsule, hard
    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 INNEscitalopram
    D.3.9.1CAS number 219861-08-2
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameS-(+)-Citalopram oxalate
    D.3.9.4EV Substance CodeAS3
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number10 to 20
    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, hard
    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
    Major Depressive Disorder
    E.1.1.1Medical condition in easily understood language
    Depression
    Condition characterised by low mood and inability to enjoy normally pleasurable experiences
    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 PT
    E.1.2Classification code 10057840
    E.1.2Term Major depression
    E.1.2System Organ Class 10037175 - Psychiatric disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10057840
    E.1.2Term Major depression
    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
    How effective is a single dose of psilocybin for major depressive disorder against an an active gold-standard medical treatment (6-weeks of escitalopram)?
    E.2.2Secondary objectives of the trial
    How do the relevant interventions affect brain activity and can brain measures be used to predict treatment response?
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives

    Significant Other Questionnaire
    We will also ask patients’ significant others for brief ratings of the patients' mood before and after the study. The Significant Other Questionnaire has ten Likert scale items, such as ‘How often does the person seem tired? 0=always 1=often 2=half the time 3=rarely 4=never’ and will need to be completed twice (pre and post intervention).

    The procedures for this sub-study will be as follows: at the screening, the patient will be asked if they consent to us contacting their significant other for the purpose of receiving ratings about the patient's mood before and after the clinical intervention. We will ask for the name and postal address and telephone number of the significant other. We will contact this person to explain that we are seeking mood ratings for the patient in question. If the are interested in participating, we will send them the information sheet and consent form and ask for them to return the signed consent form to us. We will then email/post them the pre-study questionnaire, or complete this with them over the telephone. We will explain that we will contact them at some point in the next six months to complete another rating. A few days before the patient has their 6 week follow up visit (before the blind is broken) the questionnaire will be sent to the significant other again.
    E.3Principal inclusion criteria
    Key inclusion criteria:
    1. Major depressive disorder (DSM-IV)
    2. Depression of moderate to severe degree (17+ on the 21-item HAM-D).
    2. No MRI contraindications
    3. No SSRI contraindications
    4. Has a GP or other mental healthcare professional who can confirm diagnosis
    5. 18-80 years of age
    6. Males and females
    7. Sufficiently competent with English language


    E.4Principal exclusion criteria
    Key exclusion criteria:
    1. Current or previously diagnosed psychotic disorder
    2. Immediate family member with a diagnosed psychotic disorder
    3. Medically significant condition rendering unsuitability for the study (e.g., diabetes, epilepsy, severe cardiovascular disease, hepatic or renal failure etc.)
    4. History of suicide attempts requiring hospitalisation.
    5. History of mania
    6. Psychiatric condition judged to be incompatible with establishment of rapport with therapy team and/or safe exposure to psilocybin, e.g. borderline personality disorder
    7. Blood or needle phobia
    8. Positive pregnancy test at screening or during the study
    9. Current drug or alcohol dependence
    10. No email access
    11. Use of contraindicated medication
    12. Patients presenting with abnormal QT interval prolongation at screening or with a history of this (QTc at screening above 440ms for men and above 470ms for women)
    E.5 End points
    E.5.1Primary end point(s)
    QIDS-16
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline and main endpoint = 1 week after the psilocybin dosing session
    E.5.2Secondary end point(s)
    fMRI measures

    Other clinical ratings include:

    o QIDS-16 (daily measure) [82]
    o BDI II (two-weekly measure) [13]
    o HAM-D [14]
    o MADRS [34]
    o Spielberger’s Trait Anxiety Inventory (STAI) - Trait [15]
    o Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) [16]
    o Snaith Hamilton Anhedonia Pleasure Scale (SHAPS) [17]
    o Life Orientation Test (LOT-R) [18]
    o Meaning in Life Questionnaire (MLQ) [19]
    o Brief Resilience Scale (BRS) [20]
    o Dysfunctional Attitudes Scale (DAS) [21]
    o 44-item Big Five Inventory [22]
    o Peters 21-item delusional inventory (PDI) [23]
    o EASE anomalous subjective experience [24]
    o Ruminative Responses Scale (RRS) [25]
    o White Bear Suppression Inventory (WBSI) [26]
    o Barrett Impulsivity Scale (BIS) [27]
    o Brief Experiential Avoidance Questionnaire [28]
    o Modified Tellegen Absoprtion Questionnaire (MODTAS) [29]
    o Scale To Assess the Therapeutic Relationship (STAR) [30]
    o Credibility/Expectancy Questionnaire [31]
    o Connectedness to Nature Scale (CNS) [32]
    o Political Perspective Questionnaire (PPQ)
    o Social Connectedness Scale (SCS) [33]
    o Bech-Rafaelsen Mania Rating Scale (MAS/MRS) [34]
    o Revised Santa Clara brief compassion scale (5 items) (SCBCS) [35]
    o Gratitude Questionnaire (GQ-6) [36]
    o Short Suggestibility Scale (SSS) [37]
    o Self-esteem: Rosenberg Self-Esteem Scale (4 items) (RSE) [38]
    o Universality subscale of the Spiritual Transcendence Scale (STS) [39]
    o Oxford Questionnaire on the Emotional Side-effects of Antidepressants (OQuESA) [40]
    o Lauks Emotional Intensity Scale (LEIS) [41]
    o The Suicidal Ideation Attributes Scale (SIDAS) [84]
    o Sexual dysfunction (PRSEXDQ-SALSEX) [83]
    o Barnes Akathisia Rating Scale (BARS) [85]
    o Work Productivity and Activity Impairment Questionnaire (WPAI) [87]
    o The Work and Social Adjustment Scale (WSAS) [88]
    o Self-constructed Connectedness Questionnaire
    o Standard Assessment of Personality – Abbreviated Scale (SAPAS) [96]
    o Positive and Negative Syndrome Scale (PANSS) [97]

    Measures completed just before treatment will include the:
    o Spielberger’s Trait Anxiety Inventory (STAI) - State [15]
    o The psychedelic predictor scale (self-constructed)
    o The surrender scale [65]

    Behavioural tasks will include:
    o Emotional processing battery [88]
    o Cued autobiographical memory task (AMT) [44]
    o Prediction of Future Life Events (POFLE) [45]
    o Torrance Test of Creative Thinking (TTCT) [46]
    o Emotional response to music [89]
    o California Verbal Learning Test (CVLT) [90]
    o Digit Symbol Substitution Test (DSST) [91]

    The following scales will be used to measure subjective states during the dosing sessions to be filled out at the end of the dosing session:

    o Ego Dissolution Inventory (EDI) [47]
    o Mystical Experience Questionnaire (MEQ) [48]
    o 11 Dimension Altered States of Consciousness Scale (11D ASC) [49]
    o Psychotomimetic States Inventory (PSI) [50]
    o Visual Analogue Scales (VAS)
    o Geneva Emotional Music Scales (GEMS) [51]
    o The Challenging Experience Questionnaire [52]
    o The Imperial Emotional Breakthrough Inventory (EBI)
    o Near-Death Experience (NDE) scale [53]
    o Ten Item Personality Inventory (TIPI) [88]
    E.5.2.1Timepoint(s) of evaluation of this end point
    for fMRI: Baseline and 1 week after psilocybin dosing session

    for other clinical ratings: Baseline, 1 week and 6 weeks post psilocybin dosing session (unless stated otherwise above). Exceptions: daily QIDS-16 done one day before and one day after dosing session, and BDI done every 2 weeks.

    Behavioural tasks will be conducted at baseline, 1 week and 6 weeks post psilocybin dosing (where appropriate).
    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 No
    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 Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    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 Yes
    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
    Yes, it will be the last 6-month post-dosing interview conducted with the last study subject.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    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: 45
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 50
    F.4.2.2In the whole clinical trial 50
    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)
    Those patients who were recruited from the IAPT system run out of Camden and Islington Trust, will be able to continue their psychological treatment if appropriate after the patient has completed the study. Patients recruited from elsewhere will return to the care providers from whence they came. Any patients who were on antidepressant medication before the trial will be able to return to this medication if they wish.
    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 Decision2018-04-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-11-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-04-17
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