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    Summary
    EudraCT Number:2018-002577-22
    Sponsor's Protocol Code Number:COMP003
    National Competent Authority:Ireland - HPRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2019-10-17
    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 ConcernedIreland - HPRA
    A.2EudraCT number2018-002577-22
    A.3Full title of the trial
    The safety and efficacy of psilocybin as an adjunctive therapy in participants with treatment-resistant depression
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The safety and efficacy of psilocybin as an adjunctive therapy in participants with treatment-resistant depression
    A.3.2Name or abbreviated title of the trial where available
    Psilocybin augmentation therapy for TRD
    A.4.1Sponsor's protocol code numberCOMP003
    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 SponsorCOMPASS Pathfinder, Limited
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportCOMPASS Pathfinder, Limited
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCOMPASS Pathfinder, Ltd
    B.5.2Functional name of contact pointEkaterina Malievskaia
    B.5.3 Address:
    B.5.3.1Street Address3rd Floor, 1 Ashley Road
    B.5.3.2Town/ cityAltrincham, Cheshire
    B.5.3.3Post codeWA14 2DT
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+44079 2087 6562
    B.5.6E-mailkatya@compasspathways.com
    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 5 mg
    D.3.4Pharmaceutical form Capsule
    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 INNPSILOCYBINE
    D.3.9.1CAS number 520-52-5
    D.3.9.3Other descriptive namePsilocybin
    D.3.9.4EV Substance CodeSUB10158MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    treatment resistant depression
    E.1.1.1Medical condition in easily understood language
    treatment resistant depression
    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 21.1
    E.1.2Level LLT
    E.1.2Classification code 10025454
    E.1.2Term Major depressive disorder, recurrent episode
    E.1.2System Organ Class 100000004873
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10025463
    E.1.2Term Major depressive disorder, single episode
    E.1.2System Organ Class 100000004873
    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 objective of this study is to explore the efficacy of 25 mg psilocybin as an adjunct therapy to antidepressants in improving depressive symptoms.
    E.2.2Secondary objectives of the trial
    The secondary objective is to evaluate the safety and tolerability of psilocybin in participants with TRD based on adverse events (AEs), changes in vital signs, electrocardiograms (ECGs), clinical laboratory tests and suicidal ideation/behavior (measured using the Columbia-Suicide Severity Rating Scale [C SSRS]) score.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Signed ICF.
    2.18 years of age or older, depending on country-specific limits, at Screening (V1).
    3.At least moderate MDD (single or recurrent episode as informed by DSM 5; duration of ≥ 3 months and ≤ 2 years) based on medical records, clinical assessment and documented completion of the version 7.0.2 MINI.
    4.Hamilton Depression Rating Scale (17 item) score ≥18 at Screening (V1) and Baseline (V2, Day-1).
    5.Currently receiving treatment with a selective serotonin reuptake inhibitor (SSRI; fluoxetine, fluvoxamine, sertraline, paroxetine, citalopram or escitalopram) at, or above, a minimum locally approved therapeutic dose for at least 6 weeks before Screening (V1) and Baseline (V2, Day -1). Dose changes within the adequate range are acceptable. To be defined as an adequate study, adherence of at least 75% is needed based on participant estimate of percentage of doses that were taken.
    6.Failure to respond to an adequate dose and duration of 2, 3, or 4 pharmacological treatments for the current episode as determined through the MGH-ATRQ and using the supplementary advice on additional antidepressants not included in MGH-ATRQ. Augmentation with an add on treatment counts as a second treatment, provided it is approved for the adjunctive treatment of MDD in that country.
    7.McLean Screening Instrument for Borderline Personality Disorder <7 at Screening (V1).
    8.Ability to complete all protocol required assessment tools without any assistance or alteration to the copyrighted assessments, and to comply with all study visits.
    E.4Principal exclusion criteria
    Psychiatric Exclusion Criteria:
    1.Current or past history of schizophrenia, psychotic disorder (unless substance induced or due to a medical condition), bipolar disorder, delusional disorder, paranoid personality disorder, schizoaffective disorder, or borderline personality disorder, as assessed by medical history, McLean Screening Instrument for Borderline Personality Disorder and a structured clinical interview (version 7.0.2 MINI).
    2.Prior electroconvulsive therapy and/or ketamine for current episode.
    3.Ongoing use of an antidepressant medication, including augmentation or combination therapies, other than a single SSRI at Screening (V1) and Baseline (V2, Day -1).
    4.Current psychological therapies that will not remain stable within 21 days of the psilocybin session. Psychological therapies cannot be initiated within 21 days of baseline.
    5.Current (within the last year) alcohol or substance use disorder as informed by DSM 5 (diagnosed by MINI 7.0.2) at Screening (V1).
    6.Significant suicide risk as defined by (1) suicidal ideation as endorsed on items 4 or 5 on the C-SSRS within the past year, at Screening or at Baseline, or; (2) suicidal behaviors within the past year, or; (3) clinical assessment of significant suicidal risk during participant interview.
    7.Depression secondary to other severe medical conditions according to clinicians’ judgement.
    8.Other personal circumstances and behaviour judged to be incompatible with establishment of rapport or safe exposure to psilocybin, including exposure to psilocybin within the past year and use of psychedelics, such as ayahuasca, during the current depressive episode.
    General Medical Exclusion Criteria:
    9.Women who are pregnant, nursing or planning a pregnancy. Male and female participants who are sexually active must agree to use a highly effective contraceptive method throughout their participation in the study. Women of child bearing potential must have a negative urine pregnancy test at Screening (V1) and Baseline (V2, Day -1).
    10.Cardiovascular conditions: recent stroke (<1 year from signing of ICF), recent myocardial infarction (<1 year from signing of ICF), hypertension (blood pressure >140/90 mmHg) or clinically significant arrhythmia within 1 year of signing the ICF.
    11.Uncontrolled or insulin dependent diabetes.
    12.Seizure disorder.
    13.Positive urine drug screen for illicit drugs or drugs of abuse at Screening (V1) and Baseline (V2, Day -1). Any positive urine drug test will be reviewed with participants to determine the pattern of use and eligibility will be determined at the investigator’s discretion in conjunction with the medical monitor (MM).
    14.Current enrolment in any investigational drug or device study or participation in such within 30 days prior to Screening (V1).
    15.Current enrolment in another clinical study of an investigational medical or participation in such within 30 days of Screening (V1).
    16.Abnormal and clinically significant results on the physical examination, vital signs, ECG or laboratory tests at Screening (V1).
    17.Any other clinically significant cardiovascular, pulmonary, gastrointestinal, hepatic, renal or any other major concurrent illness that, in the opinion of the investigator, may interfere with the interpretation of the study results or constitute a health risk for the participant if he/she takes part in the study.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the change in MADRS total score from Baseline (Day 1) to 3 weeks post psilocybin administration.
    E.5.1.1Timepoint(s) of evaluation of this end point
    3 Weeks post-psilocybin
    E.5.2Secondary end point(s)
    •The proportion of participants with a response (defined as a ≥ 50% improvement in MADRS total score from Baseline) at Week 3 post psilocybin administration
    •The proportion of participants with remission (defined as a MADRS total score ≤ 10) at Week 3 post psilocybin administration
    •Changes from Baseline in CGI-S score at Week 3 post psilocybin administration.
    •Incidence of AEs
    •Change from Baseline to Day 1 in ECGs, and incidence of clinically important changes
    •Change from Baseline to Day 1 and to Week 3 in clinical laboratory tests, and incidence of clinically important changes
    •Change from Baseline to Day 1 in vital signs
    •Incidence of changes from Baseline in the C-SSRS at each post Baseline visit
    E.5.2.1Timepoint(s) of evaluation of this end point
    See section 7.1.1
    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 No
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    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
    1 treatment arms 25 mg treatement
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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.8.5The 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 Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    United States
    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
    LPLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    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.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 18
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 2
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 10
    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)
    It will be whatever standard of care/practice is applicable in each country.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-12-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-10-13
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