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    Summary
    EudraCT Number:2017-003288-36
    Sponsor's Protocol Code Number:COMP001
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-12-14
    Trial results View 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 ConcernedGermany - BfArM
    A.2EudraCT number2017-003288-36
    A.3Full title of the trial
    The Safety and Efficacy of Psilocybin in Participants with Treatment Resistant Depression (P-TRD)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The Safety and Efficacy of Psilocybin in Participants with Treatment Resistant Depression
    A.3.2Name or abbreviated title of the trial where available
    Psilocybin in Participants with Treatment Resistant Depression (P-TRD)
    A.4.1Sponsor's protocol code numberCOMP001
    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, Limited
    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 INNPSILOCYBIN
    D.3.9.1CAS number 520-52-5
    D.3.9.3Other descriptive namePsilocybin
    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 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.IMP: 2
    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 1 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 INNPSILOCYBIN
    D.3.9.1CAS number 520-52-5
    D.3.9.3Other descriptive namePsilocybin
    D.3.9.4EV Substance CodeAS2
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule
    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
    Treatment-Resistant Depression (P-TRD)
    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 main purpose of Period 1 of this study is to allow COMPASS to determine the optimal dose of psilocybin, either 10 mg or 25 mg. The intent of the primary efficacy analysis, which occurs during Period 2 of the study, is to demonstrate superiority of the optimal therapeutic dose of psilocybin (10 mg or 25 mg) versus the 1 mg psilocybin via the following objectives:

    The primary objective of this study is to evaluate the efficacy of psilocybin (25 mg or 10 mg) compared to 1 mg, administered under supportive conditions to adult participants with TRD, in improving depressive symptoms, as assessed by the change in the Montgomery-Asberg Depression Rating Scale (MADRS) total score from Baseline. Baseline is defined as the assessment score obtained on Day -1. The primary timepoint is Week 3; this variable will be analysed for the change from Baseline to Weeks 1, 3, 6, and 12.
    E.2.2Secondary objectives of the trial
    To assess the efficacy of psilocybin compared to 1 mg psilocybin on:
    - Proportion of participants with response defined as a ≥50% decrease in MADRS total score from Baseline to Week 3. This will also be assessed at Weeks 1, 6 and 12.
    - The proportion of participants who have a sustained response at Week 12. Sustained response is defined as the proportion of patients fulfilling response criteria at any visit up to and including Week 3, that also fulfils response criteria at all subsequent visits up to and including Week 12. Response is defined as ≥50% decrease in MADRS total score from Baseline.
    - To evaluate the safety and tolerability of psilocybin in participants with TRD based on adverse events (AEs), changes in vital signs, and suicidal ideation/behaviour (measured using the Columbia-Suicide Severity Rating Scale[C-SSRS]) score at all visits.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Participants meeting all the following inclusion criteria at Screening (V1) should be considered for admission into the study:

    1. Signed Informed Consent Form (ICF).
    2. 18 years of age or older at Screening (V1).
    3. At least moderate MDD (single or recurrent episode as informed by DSM-5; if single episode, duration of ≥ 3 months and ≤2 years) based on medical records, clinical assessment and documented completion of the version 7.0.2 MINI.
    4. HAM-D-17 (17-item) score ≥18 at Screening (V1) and at Baseline (V2).
    5. Failure to respond to an adequate dose and duration of 2, 3, or 4 pharmacological treatment for the current episode as determined through the MGH ATRQ and using the supplementary advice on additional antidepressants not included in MGH ATRQ (Appendix III). Augmentation with an add on treatment counts as a second treatment, provided it is approved for the adjunctive treatment of MDD in that country.
    6. McLean Screening Instrument for Borderline Personality Disorder <7 at Screening (V1).
    7. Not taking any antidepressants, mood stabilizers, or antipsychotics at the time of Screening Visit 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
    Participants meeting any of the following exclusion criteria at Screening (V1) will not be enrolled in the study:

    Psychiatric Exclusion Criteria:
    1. Current or past history of schizophrenia, depression with psychotic features, bipolar disorder, delusional disorder, paranoid personality disorder, schizoaffective disorder, borderline personality disorder, post traumatic stress disorder (PTSD) or any serious psychiatric comorbidity as assessed by medical history and a structured clinical interview (version 7.0.2 MINI).
    2. Prior electroconvulsive therapy and/or ketamine for current episode.
    3. Current psychotherapy that will not remain stable for the duration of the study. Psychotherapy cannot be initiated within 21 days of baseline.
    4. Current (within the last year) alcohol or substance use disorder as informed by DSM 5 at Screening (V1).
    5.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) prior suicidal attempts, or; (3) clinical assessment of significant suicidal risk during subject interview.
    6. Depression secondary to other severe medical conditions.
    7. Other personal circumstances and behaviour judged to be incompatible with establishment of rapport or safe exposure to psilocybin.
    8.Prior exposure to psilocybin and other psychedelics.

    General Medical Exclusion Criteria:
    9. Women who are pregnant, nursing, or planning a pregnancy. Participants who are sexually active must agree to use an acceptable 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).
    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 insulin-dependent diabetes.
    12. Seizure disorder.
    13. Positive urine drug screen for illicit drugs or drugs of abuse at V1 and V2. 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 MM.
    14. Current enrolment in any investigational drug or device study or participation in such within 30 days of Screening (V1).
    15. Current enrolment in an interventional study for depression 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.
    E.5.1.1Timepoint(s) of evaluation of this end point
    3 Weeks post-psilocybin
    E.5.2Secondary end point(s)
    The secondary endpoints are:
    • The proportion of participants with a response (defined as a ≥50% improvement in MADRS total score from Baseline) at Week 3 post-psilocybin.
    • The proportion of participants with remission (defined as a MADRS total score ≤10) at Week 3 post-psilocybin.
    • The proportion of participants who have a sustained response at Week 12. Sustained response is defined as the proportion of patients fulfilling response criteria at any visit up to and including Week 3, that also fulfils response criteria at all subsequent visits up to and including Week 12. Response is defined as ≥50% decrease in MADRS total score from Baseline.
    • Time to event measures: start antidepressant medication for any reason, start medication for continuing depressive symptoms, and relapse from a previously recovered state (clinical judgement, supported by the QIDS-SR-16). Participants who withdraw from the study will be censored from the time to event analysis.
    E.5.2.1Timepoint(s) of evaluation of this end point
    See section E.5.2
    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 Yes
    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 Yes
    E.8.1.7.1Other trial design description
    adaptive design, fixed dose, with 2 periods
    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.8.2.3.1Comparator description
    3 treatment arms: 25 mg treatement, 10 mg treatment, 1 mg treatment
    E.8.2.4Number of treatment arms in the trial3
    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 concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA10
    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
    LVLS
    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 months4
    E.8.9.1In the Member State concerned days30
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months4
    E.8.9.2In all countries concerned by the trial days30
    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: 358
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 398
    F.4.2.2In the whole clinical trial 398
    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)
    Participants who are randomised into period 2 will be offered a re-treatment at week 12 if they meet the assessment criteria.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-02-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-08-03
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-09-27
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