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    Summary
    EudraCT Number:2020-002790-94
    Sponsor's Protocol Code Number:200828
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-06-30
    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 ConcernedSweden - MPA
    A.2EudraCT number2020-002790-94
    A.3Full title of the trial
    The Effect of Psilocybin on MDD Symptom Severity and Synaptic Density – A Single Dose Randomized, Double Blind, Placebo-Controlled Phase 2 Positron Emission Tomography Study
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The Effect of Psilocybin on Depressive Symptom Severity and Neuronal Connection Density – A Single Dose Randomized, Double Blind, Placebo-Controlled Phase 2 Positron Emission Tomography Study
    A.3.2Name or abbreviated title of the trial where available
    PSIPET
    A.4.1Sponsor's protocol code number200828
    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 SponsorSLSO
    B.1.3.4CountrySweden
    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 supportKarolinska Institutet
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSLSO
    B.5.2Functional name of contact pointPSIPET information
    B.5.3 Address:
    B.5.3.1Street AddressVårdvägen 3
    B.5.3.2Town/ cityStockholm
    B.5.3.3Post code11219
    B.5.3.4CountrySweden
    B.5.6E-mailjohanna.evengard@sll.se
    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 Psilocybin
    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.3.9.2Current sponsor codePsilocybin
    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 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 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 nameNiacin
    D.3.2Product code Niacin
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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
    Major Depressive Disorder
    E.1.1.1Medical condition in easily understood language
    Depression
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10025462
    E.1.2Term Major depressive disorder, recurrent episode, unspecified degree
    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 evaluate the efficacy of a single 25 mg oral dose of psilocybin for major depressive disorder (MDD) compared to an active placebo (niacin) in otherwise medically-healthy participants between the ages of 20 and 65, assessed as the difference between groups in changes in depressive symptoms.
    E.2.2Secondary objectives of the trial
    One secondary objective is to evaluate the effect of psilocybin on synaptic density in prefrontal cortex and hippocampus, by comparing the change in [11C]UCB-J binding after psilocybin and placebo dosing.

    The other exploratory objective is to study the clinical effect on depressive symptoms, clinical global impression, perceived disability and of post treatment use of antidepressants.

    Exploratory objectives: is to evaluate the effect of psilocybin on biological markers of synaptogenesis, neuroinflammation, serotonergic activity and on self-rated depressive symptoms, reversal fear learning, clinical global functioning, anxiety symptoms, functional disability, health-related meaning of/satisfaction with life and psychological flexibility, subjective psychedelic experiences, participants’ expectations prior to the/experience of the intervention, and facilitator and participants’ in-session behaviors.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion Criteria
    Individuals eligible to be randomized in this protocol are those who meet all of the following criteria:

    1. Are 20 to 65 years old at the time of written informed consent at the In-Person Screening visit
    2. Are able to read, speak, and understand Swedish
    3. Are able and willing to adhere to study requirements, including attending all study visits, preparatory and follow-up sessions, and completing all study evaluations
    4. Are able to swallow capsules
    5. Women of childbearing potential (WOCBP) must agree to practice an effective means of birth control throughout the duration of the study, from Screening through the Day 42 assessment
    6. Meet ICD-10 criteria for a diagnosis of remitting major depressive disorder and are currently experiencing a major depressive episode of
    a) at least a 30-day duration at the time of the Screening
    b) less than 5 years at time of Screening
    7. Have sustained moderate-severe depression symptoms at Screening and Baseline, as defined by a Screening MADRS total score ≥ 22 and ≤30% and ≤7 point improvement (i.e. decrease) in MADRS total score from web-screening to screening visit (assuming 3 points on item 1 at web screening).
    9. Have an identified support person
    a. Agree to be driven/accompanied home (or to an otherwise safe destination) by the support person, or another responsible party, following dosing
    E.4Principal exclusion criteria
    Exclusion Criteria
    Individuals not eligible to be randomized in this protocol are those who meet any of the following criteria:

    1. Women who are pregnant, as indicated by a positive urine pregnancy test at Screening or Baseline. Women who intend to become pregnant during the study or who are currently nursing.
    2. Current depressive episode lasting >5 years
    2. Unwilling or unable to discontinue formal psychotherapy
    3. Ongoing antidepressant drug treatment
    4. Have previously during the current episode received the following non-medication treatments:
    a. deep brain stimulation (DBS)
    b. vagus nerve stimulation (VNS)
    5. Currently receiving electroconvulsive therapy (ECT) or transcranial magnetic stimulation (TMS)
    6. Unable or unwilling to discontinue any current medications that are known uridine diphosphate (UDP) or glucuronosyltransferase (UGT) enzyme modulators (eg valproate)
    o Note: Any prohibited agents must have been stopped at least 5x the elimination half-life of the specific drug at the time of Baseline. See Appendix A for a full list of prohibited medications.
    7. Report psychedelic substances use ever
    o Note: Psychedelic substances include psilocybin, Lysergic acid diethylamide (LSD), mescaline (and natural products containing mescaline including peyote and San Pedro cactus), N,N-Dimethyltryptamine (DMT), natural products containing DMT including ayahuasca and 5-Methoxy-N,N-dimethyltryptamine (5-MeO-DMT), ibogaine, 2C compounds, 3,4-methylenedioxy- methamphetamine (MDMA), methylone or other psychedelics.
    8. Have the following cardiovascular conditions:
    a. coronary artery disease, congenital long QT syndrome (prior diagnosis), cardiac hypertrophy, cardiac ischemia, congestive heart failure, myocardial infarction (prior diagnosis);
    b. tachycardia (defined as heart rate > 100 beats per minute);
    c. a clinically significant Screening ECG abnormality (e.g., atrial fibrillation);
    oNote: A QTcF interval > 450 milliseconds is considered a clinically significant ECG abnormality
    d. artificial heart valve; or
    e. any other significant current or history of cardiovascular condition, based on the clinical judgment of study physician, that would make a participant unsuitable for the study
    9. At Screening or Baseline have elevated blood pressure as defined as:
    a. Screening blood pressure SBP >135 mmHg or DBP > 85 mmHg on three separate readings; or
    b. Baseline blood pressure SBP >140 mmHg or DBP > 90 mmHg on three separate readings
    10. Have a history of stroke or Transient Ischemic Attack (TIA)
    11. Have moderate to severe hepatic impairment, as indexed by a Child-Pugh score ≥ 7
    12. Have epilepsy
    13. Have insulin-dependent diabetes
    o Note: Participants who are taking oral hypoglycemic agent and have a history of hypoglycemia requiring medical intervention will be excluded
    14. Are unable or unwilling to adhere to the following medication requirements:
    a. Agree to suspend sildenafil (Viagra®), tadalafil, or similar medications at least 72 hours prior to dosing
    b. If taking any supplement containing >20 mg of niacin, agrees to suspend use for the duration of the study
    15. Have a positive urine drug test including Amphetamines, Barbiturates, Buprenorphine, Benzodiazepines, Cocaine, Cannabis, Methamphetamine, MDMA, Methadone, Opiates (Morphine, Oxycodone), Phencyclidine (PCP), and Tetrahydrocannabinol (THC). Exceptions are made for prescribed Benzodiazepines (stable dose for sleep or anxiety).
    o Note: Benzodiazepine medications for sleep and non-benzodiazepine sleeping medications will be allowed to continue through the study period for participants who have been on a stable dose of such a medicine for at least 6 weeks prior to Screening, as determined during review of concomitant medications
    16. Nicotine dependence that would disallow an individual to be nicotine free for the 7-10 hours during the dosing period
    17. Meet ICD-10 criteria for schizophrenia spectrum or other psychotic disorders, including MDD with psychotic features (except substance/medication-induced or due to another medical condition), or Bipolar I Disorder, Bipolar II Disorder and bipolar disorder NOS.
    o Note: Participants with any lifetime diagnosis of schizophrenia spectrum or other psychotic disorders will be excluded
    18. Meet ICD-10 criteria for antisocial personality disorder
    19. Meet ICD-10 criteria for a moderate or severe alcohol or drug use disorder (excluding caffeine)
    o Note: Participants with a diagnosis of alcohol or drug use disorder within the past 12 months will be excluded
    20. Have presence of any psychiatric condition or symptom judged by the PI (or designee) to be a more significant clinical problem than MDD for the participant.
    21. Have a first-degree relative with schizophrenia spectrum or other psychotic disorders (except substance/medication-induced or due to another medical condition), or Bipolar I Disorder
    NB - Truncated, >5000 characters
    E.5 End points
    E.5.1Primary end point(s)
    Primary Outcome Measure
    Change in blinded rater MADRS total score from Baseline to Day 8.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 8 after dosing
    E.5.2Secondary end point(s)
    Secondary Outcome Measures
    • Relative increase (ratio) in [11C]UCB-J binding from Baseline to Day 15 post dose
    • Change in MADRS total score from Baseline to Day 15, 42, 180 and 365 (end of study) respectively
    • Change in MADRS total score from Baseline to the treatment period (mean of Day 8-365)
    • Change in MADRS-S score from Baseline to Day 365 (end of study)
    • Change in MADRS-S score from Baseline to the treatment period (mean of Day 8-365)
    • Response rate at all time points post dose (MADRS and MADRS-S)
    • Remission rate at all time points post dose (MADRS and MADRS-S)
    • Change in Sheehan Disability Scale (SDS) score from Baseline to Day 365 (end of study)
    • Change in SDS score from Baseline to the treatment period (mean of Day 8-365)
    • Change in Clinical Global Impression (CGI) score from Baseline to Day 8, 42, 180 and 365 (end of study) respectively
    • Change in CGI score from Baseline to the treatment period (mean of Day 8-365)
    • Time to initiation of antidepressant treatment in follow up phase (day 43-365)

    Exploratory Outcome Measures
    1. Biomarkers
    1.1. fMRI BOLD signal
    1.2. fMRI activation paradigms post dosing
    1.3. p11 (blood)
    1.4. BDNF and VEGF (plasma)
    1.5. monoamines and monoamine metabolites (CSF)
    1.6. cytokines (CSF)
    1.7. kynurenic acid and metabolites (CSF)

    2. Scales
    2.1. General Anxiety Disorder 7 (GAD-7)
    2.2. Euroqol five dimension five level (E-5D-5L)
    2.3. Euroqol visual analogue scale (EQ-VAS)
    2.4. Mystical Experience Questionnaire (MEQ)
    2.5. Emotional Breakthrough Inventory (EBI)
    2.6. Challenging Experience Questionnaire (CEQ)
    2.7. Lasting Effects Questionnaire (LEQ)
    2.8. Treatment Expectation and Evaluation questionnaires
    2.9. Meaning of Life Questionnaire (MLQ)
    2.10. Satisfaction with Life Scale (SWLS)
    2.11. Acceptance in Action Questionnaire (AAQ-II)
    2.12. The Actively Living and Interconnecting Vitally in one’s Embedded-world (ALIVE) Questionnaire
    2.13. Working Alliance Inventory-Short (WAI-S)
    2.14. Motivational Interviewing Treatment Integrity Code (MITI)
    2.15. Client Language Easy Rating (CLEAR)
    2.16. Scale for Psychedelic Intensity Rating (SPIR)

    Safety Objectives
    The overall safety objective of this study is to evaluate a single 25 mg oral dose of psilocybin compared to an active placebo in incidence, severity and frequency of Adverse Events (AEs), Treatment Emergent AEs (TEAEs), and Serious Adverse Events (SAEs) during and after the dosing session and at all follow-up visits. Solicited AEs will be compared from randomization until day 8 only.
    E.5.2.1Timepoint(s) of evaluation of this end point
    [11C]UCB-J binding Day 15 post dose
    MADRS total score Day 15, 42, 180 and 365 (end of study)
    MADRS total score to the treatment period (mean of Day 8-365)
    MADRS-S score from Baseline to Day 365 (end of study)
    MADRS-S score from Baseline to the treatment period (mean of Day 8-365)
    Response rate at all time points post dose (MADRS and MADRS-S)
    Remission rate at all time points post dose (MADRS and MADRS-S)
    Sheehan Disability Scale (SDS) score from Baseline to Day 365 (end of study)
    SDS score from Baseline to the treatment period (mean of Day 8-365)
    Clinical Global Impression (CGI) score from Baseline to Day 8, 42, 180 and 365 (end of study) respectively
    CGI score from Baseline to mean of Day 8-365
    Time to initiation of antidepressant (day 43-365)
    Safety to day 8.
    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 Yes
    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 Yes
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    active placebo (niacine)
    E.8.2.4Number of treatment arms in the trial2
    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 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 years2
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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: 30
    F.1.3Elderly (>=65 years) No
    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.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)
    None than the ones stated in protocol.
    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 Decision2020-09-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-09-16
    P. End of Trial
    P.End of Trial StatusOngoing
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