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    Summary
    EudraCT Number:2021-006861-39
    Sponsor's Protocol Code Number:GH001-BD-202
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-03-31
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2021-006861-39
    A.3Full title of the trial
    A Phase 2 Clinical Trial of GH001 in Patients with Bipolar II Disorder and a Current Major Depressive Episode
    (GH001-BD-202)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 2 Clinical Trial of GH001 in Patients with Bipolar II Disorder and a Current Major Depressive Episode
    A.4.1Sponsor's protocol code numberGH001-BD-202
    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 SponsorGH Research Ireland Limited
    B.1.3.4CountryIreland
    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 supportGH Research Ireland Limited
    B.4.2CountryIreland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGH Research Ireland Limited
    B.5.2Functional name of contact pointGH Research Project Manager
    B.5.3 Address:
    B.5.3.1Street Address28 Baggot Street Lower
    B.5.3.2Town/ cityDublin 2
    B.5.3.3Post codeD02 NX43
    B.5.3.4CountryIreland
    B.5.4Telephone number0035314378443
    B.5.6E-mailclinicaltrials@ghres.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 name5-MeO-DMT 6,12 and 18mg powder in vial for reconstitution
    D.3.2Product code GH001
    D.3.4Pharmaceutical form Inhalation vapour, solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN5-Methoxy-N,N-Dimethyltryptamine
    D.3.9.1CAS number 1019-45-0
    D.3.9.2Current sponsor codeGH001
    D.3.9.3Other descriptive nameNA
    D.3.9.4EV Substance CodeSUB222872
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number36
    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 Yes
    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
    Bipolar II Disorder
    E.1.1.1Medical condition in easily understood language
    Form of mental illness where patients experience major depressive episodes and at least one hypomania episode.
    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 HLGT
    E.1.2Classification code 10026753
    E.1.2Term Manic and bipolar mood disorders and disturbances
    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
    To determine the onset and 7-day durability of anti-depressive effects of a single-day individualized dosing regimen of 6 mg, 12 mg and 18 mg of GH001 in patients with bipolar II disorder and a current major depressive episode.
    E.2.2Secondary objectives of the trial
    • To determine:
    o the safety and tolerability
    o the intensity and duration of the psychoactive effects (PsE)
    o the impact on cognitive outcomes.

    of a single-day individualized dosing regimen of 6 mg, 12 mg and 18 mg of GH001 in patients with bipolar II disorder and a current major depressive episode.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Is male or female and in the age range between 18 and 64 years (inclusive) at screening;
    • Meets the trial criteria for bipolar II disorder and is experiencing a major depressive episode:
    • Meets the DSM-5 diagnostic criteria for bipolar II disorder with a current major depressive disorder episode confirmed by the Mini-International Neuropsychiatric Interview (MINI) v7.0.2
    • Has a Montgomery–Åsberg Depression Rating Scale (MADRS) total score of ≥ 24 at screening and pre-dose on Day 0
    • Has a Young Mania Rating Scale (YMRS) total score ≤ 8 at screening and prior to first dose on Day 0;
    • Agrees to keep any psychotherapy unchanged, and not initiate any new psychoactive medications during the trial;
    • Male patients must use prophylactic contraception (i.e., condom with spermicide or abstinence) and must not donate sperm for 30 days after GH001 dosing;
    E.4Principal exclusion criteria
    • Has bipolar II disorder with rapid cycling (four or more episodes of hypomania or depressive episodes in previous 12-month period);
    • Has, based on history, psychiatric assessment, and evaluation of the MINI, a current or prior diagnosis of bipolar I disorder, a manic episode, a psychotic disorder, major depressive disorder (MDD) or other mood disorder with psychotic features, obsessive compulsive disorder, PTSD, autism spectrum disorder, borderline personality disorder, clinically significant intellectual disability or any other psychiatric comorbidity that renders the patient unsuitable for the trial according to the investigator’s judgment;
    • Has one or more first or second degree relatives with a current or previously diagnosed psychotic disorder or MDD with psychotic features;
    • Is in the judgment of a trial psychiatrist or registered psychologist, at significant risk for suicide based on history, psychiatric assessment, and evaluation of suicidal ideation and suicidal behaviour based on the C-SSRS;
    • Has had an inadequate response to an adequate course of electroconvulsive therapy, vagal nerve stimulation, repetitive transcranial magnetic or electrical stimulation, or deep brain stimulation in the current episode of depression as assessed using the ATHF-SF;
    • Female patient who has a positive pregnancy test at screening or on the pre-test day (Day -1), is pregnant or lactating, or plans to become pregnant during the course of the trial and up to 30 days after GH001 dosing;
    • Patients with DSM-5 drug or alcohol use disorder within 6 months prior to screening.
    E.5 End points
    E.5.1Primary end point(s)
    •The anti-depressive effects of GH001 evaluated by:
    o Change from baseline in MADRS

    E.5.1.1Timepoint(s) of evaluation of this end point
    • Prior to first dose on Day 0;
    • Day 7.
    E.5.2Secondary end point(s)
    • The anti-depressive effects of GH001 evaluated by:
    • The proportion of patients in remission (MADRS ≤10);
    •Change from baseline in MADRS assessed;
    • The proportion of responders (≥50% reduction from baseline in MADRS total score);
    • Change from baseline in Clinical Global Impression – Bipolar scale (CGI-BP);
    • Change from baseline in Bipolar Depression Rating Scale (BDRS);
    • The safety and tolerability of GH001 evaluated by:
    • Reporting of Treatment Emergent Adverse Events (TEAEs);
    • Clinically significant changes from baseline in ECG, vital signs, safety laboratory assessments, peak flow respirometry;
    • Assessment of sedation (Modified Observer'’s Assessment of Alertness and Sedation scale [MOAA/S]);
    • The incidence of AEs of mania or hypomania (as assessed using the DSM-5 criteria for mania/hypomania);
    • Change from baseline in YMRS;
    • Change from baseline in Clinician Administered Dissociative States Scale (CADSS);
    • Assessment of patient discharge readiness using the Clinical Global Assessment of Discharge Readiness (CGADR);
    • Change from baseline in Brief Psychiatric Rating Scale (BPRS);
    • Change from baseline in Columbia-Suicide Severity Rating Scale (C-SSRS);
    The PsE experienced by the patients when the PsE has subsided:
    • PsE assessment using the Peak Experience (PE) Scale to assess the achievement of a PE (PE scale total score ≥75);
    • Challenging Experience Questionnaire (CEQ);
    • Mystical Experience Questionnaire (MEQ-30);
    • Duration of the PsEs defined as the time from study drug dosing to the time when the PsE have subsided;
    The impact on cognitive outcomes as evaluated by:
    • Psychomotor Vigilance Task;
    • Auditory Verbal Learning Test;
    • Spatial Working Memory Task;
    • Digit Symbol Substitution Task.
    E.5.2.1Timepoint(s) of evaluation of this end point
    • 2 hours after the final study drug dosing on Day 0, and at Day 1 and Day 7;
    • 2 hours after the final study drug dosing on Day 0, and at Day 1;
    • at 2 hours after the final study drug dosing on Day 0, and at Day 1 and Day 7;
    • Day 0, Day 1 and Day 7;
    • Day 0, Day 1 and Day 7;
    • from first dosing to Day 7;
    • Day-1, Day 0, Day 1 and Day 7;
    • Day 0;
    • Day 0, Day 1 and Day 7;
    • Day 0, Day 1 and Day 7;
    • Day 0 and at Day 1 and Day 7;
    • on Day 0;
    • Day-1, Day 0, Day 1 and Day 7;
    • Screening, Day 0, Day 1 and Week 1;
    • immediately after each dosing;
    • Day 0;
    • Day 0;
    • Day 0;
    • Day-1, Day 0 and Day 7;
    • Day-1, Day 0 and Day 7;
    • Day-1, Day 0 and Day 7;
    • Day-1, Day 0 and Day 7;
    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 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
    Open-label, non-randomized, 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 No
    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.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA2
    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
    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 months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    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: 15
    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 state9
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 15
    F.4.2.2In the whole clinical trial 15
    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
    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 Decision2022-03-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-06-20
    P. End of Trial
    P.End of Trial StatusOngoing
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