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    EudraCT Number:2021-006861-39
    Sponsor's Protocol Code Number:GH001-BD-202
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-06-08
    Trial results
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGermany - BfArM
    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
    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.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.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.5.4Telephone number0035314378443
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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 IDR of 6 mg, 12 mg and 18 mg of GH001 in patients with bipolar II disorder and a current major episode of depression.
    E.2.2Secondary objectives of the trial
    • To determine:
    o the effect on depressive symptoms and global clinical status;
    o the safety and tolerability;
    o the intensity and duration of the psychoactive effects (PsE);
    o the impact on sleep quality;
    o the impact on cognitive outcomes

    Of a single-day IDR of 6 mg, 12 mg and 18 mg of GH001 in patients with bipolar II disorder and a current major episode of depression.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    5. Meets the trial criteria for bipolar II disorder and is experiencing a major depressive episode, as assessed by a trial psychiatrist or registered clinical psychologist:
    -Meets the DSM-5 diagnostic criteria for bipolar II disorder with a current major depressive episode confirmed by the Mini-International Neuropsychiatric Interview (MINI) v7.0.2 -Has a Montgomery-Asberg Depression Rating Scale (MADRS) total score of ≥ 24 at screening and prior to first dose on Day 0
    8. Female patients must be either surgically sterile (hysterectomy, tubal ligation, or bilateral oophorectomy) or postmenopausal with amenorrhea for the last 2 years or remain completely abstinent (complete avoidance of heterosexual intercourse) or use a highly effective (failure rate <1%) medically accepted contraceptive method, including, but not limited to, hormone contraceptives that inhibit ovulation, intrauterine device (including hormone-releasing intrauterine device/systems) for 30 days before and 90 days after GH001 dosing and must have a negative serum pregnancy test at screening and a negative urine pregnancy test on the pre-test day (Day -1).
    10. Is able to inhale 3 liters of air from the test balloon within a single breath at screening, on the pre-test day (Day -1) and prior to first dose (Day 0). An incentive spirometer will be given to patients following screening. They will be encouraged to practice deep inhalations prior to the first dose on the test day (Day 0). Patients failing the test inhalation at screening may have the test inhalations repeated within 14 days of the original screening date.
    E.4Principal exclusion criteria
    2. 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, post-traumatic stress disorder (PTSD), autism spectrum disorder, borderline personality disorder, schizophrenia, delusional disorder, paranoid personality disorder, schizoaffective disorder, clinically significant intellectual disability, or any other psychiatric comorbidity that renders the patient unsuitable for the trial according to the investigator’s judgment.
    3. Has one or more first degree relatives with a current or previously diagnosed psychotic disorder, bipolar I disorder, or MDD with psychotic features.
    4. Has significant suicide risk as defined by:
    (a) suicidal ideation as endorsed on items 4 or 5 on the C-SSRS within the past year, during the screening period, or at Baseline; or
    (b) suicidal behaviors within the past year; or
    (c) clinical assessment of significant suicidal risk during clinical interview; or
    (d) non-suicidal self-injury within the past year.
    6. Has taken anti-depressive medication e.g., a selective serotonin reuptake inhibitor (SSRI) such as paroxetine, fluoxetine (including in combination with olanzapine) or citalopram, a serotonin and norepinephrine reuptake inhibitor (SNRI) such as venlafaxine or duloxetine, a tricyclic antidepressant (TCA) such as amitriptyline or imipramine, an antipsychotic such as quetiapine, an atypical antidepressant such as bupropion or vortioxetine, or an N-methyl-D-aspartate (NMDA) receptor antagonist such as esketamine, within 7 days or 5 half-lives (whichever is longer) prior to dosing (exception: within the last 5 weeks in the case of fluoxetine).
    Patients who at screening are on such medication and are willing to discontinue and observe a wash-out period of 7 days or 5 half-lives (whichever is longer) prior to GH001 dosing (5 weeks for fluoxetine), can still be included, but the wash-out must be implemented, completed and documented before study drug administration. Gradual dose reduction before discontinuation and wash-out should be performed as per the investigator’s judgement and applicable medical guidelines.
    To ascertain patient safety during the potential taper and washout of anti-depressive medication, patients undergoing such taper and washout will be contacted weekly by the site.
    8. Is taking mood stabilizer therapy other than lamotrigine at screening or is, by the investigator, considered to be in the need of mood stabilizer treatment other than lamotrigine during the study.
    If a patient has formerly been treated with a mood stabilizer, a period of at least 6 months without receipt of any mood stabilizer (except lamotrigine) and occurrence of any hypomanic episode is required prior to dosing.
    18. Has any current or past clinically significant condition (e.g., severe infection, severe pulmonary disease, uncontrolled hypertension, uncontrolled diabetes, severe cardiovascular disease, severe hepatic or renal failure, severe brain disorder (including seizure disorder, stroke, dementia, degenerative neurologic diseases, meningitis, encephalitis, and head injury with loss of consciousness) that may interfere with the interpretation of the trial results, constitutes a health risk for the patient, or that otherwise renders the patient unsuitable for the trial according to the investigator’s judgment.
    24. Patients with DSM-5 alcohol or substance use disorder (excluding tobacco and caffeine use disorders) within 6 months prior to screening.
    25. If a smoker, is unwilling or unable to abstain from cigarette smoking or vaping on the day of study drug administration (nicotine replacement therapy is permitted).
    28. A positive Coronavirus Disease 2019 (COVID-19) test during the screening or on Day 0 as confirmed by an antigen or polymerase chain reaction test. Subjects with a positive test result for COVID-19 during the screening period or on the scheduled trial dosing day may be rescreened following a negative COVID-19 test result and clinical recovery.
    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 – Severity scale (CGI-S);
    • 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, spirometry assessments;
    • 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 Assessment of Discharge Readiness (CADR);
    • Change from baseline in Brief Psychiatric Rating Scale (BPRS);
    • C-SSRS categorization based on the Columbia Classification Algorithm of Suicide Assessment (C-CASA).

    The PsE experienced by the patients when the PsE has subsided:
    • PsE assessment using the Peak Experience (PE) scale (PES) to assess the achievement of a PE (PES total score ≥75);
    • Challenging Experience Questionnaire (CEQ);
    • Mystical Experience Questionnaire (MEQ30);

    Duration of the PsEs defined as the time from study drug dosing to the time when the PsE have subsided;

    The impact on sleep quality as evaluated by change from pre-test day (Day -1) to Day 1 and to Day 7 in the Pittsburgh Sleep Quality Index (PSQI)

    The impact on cognitive outcomes as evaluated by:
    • Rapid Visual Information Processing Test;
    • Verbal Recognition Memory Test;
    • Spatial Working Memory Test;
    • Digit Symbol Substitution Test.
    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;
    • at 2 hours after the final study drug dosing on Day 0, and at Day 1 and Day 7;
    • Day 1 and Day 7;
    • 60 min after each dosing and at discharge on Day 0;
    • Day 0, Day 1, and Day 7;
    • Day 0, Day 1, and Day 7;
    • Day 0, Day 1, and Day 7;
    • 30-60 min after each dosing;
    • 30-60 min after each dosing;
    • Day -1, Day 1, Day 7;
    • Day -1, Day 0, Day 1, 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. 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. 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 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA4
    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
    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 months0
    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 months0
    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)
    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 Decision2022-10-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-08-16
    P. End of Trial
    P.End of Trial StatusOngoing
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