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    Summary
    EudraCT Number:2018-004208-20
    Sponsor's Protocol Code Number:GH001-MDD-102
    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:2019-07-01
    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 number2018-004208-20
    A.3Full title of the trial
    A phase 1/2 study of GH001 in patients with treatment-resistant depression
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase 1/2 study of GH001 in depression
    A.3.2Name or abbreviated title of the trial where available
    Phase 1/2 study of GH001 in depression
    A.4.1Sponsor's protocol code numberGH001-MDD-102
    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 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 Limited
    B.4.2CountryIreland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGH Research Limited
    B.5.2Functional name of contact pointGH Research Clinical Team
    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.5.6E-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.3.2Product code GH001
    D.3.4Pharmaceutical form Inhalation 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.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2 to 18
    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
    Treatment-resistant depression
    E.1.1.1Medical condition in easily understood language
    Depression that has not responded sufficiently to previous treatment
    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 PT
    E.1.2Classification code 10012378
    E.1.2Term Depression
    E.1.2System Organ Class 10037175 - Psychiatric disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10057840
    E.1.2Term Major depression
    E.1.2System Organ Class 10037175 - Psychiatric disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10025453
    E.1.2Term Major depressive disorder NOS
    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
    Phase 1 (Part A):
    Primary objective: The primary objective of this study is to assess the safety and tolerability of single-day dosing of GH001 in patients with TRD.
    Phase 2 (Part B):
    Primary objective: The primary objective of this study is to assess the effects of single-day dosing of GH001 on the severity of depression.
    E.2.2Secondary objectives of the trial
    Phase 1 (Part A):
    Secondary Objective(s): The secondary objectives of the study are to assess the effects of single-day dosing of GH001 on various measures of depression, and on dose-related psychoactive effects.
    Phase 2 (Part B):
    Primary objective: The primary objective of this study is to assess the effects of single-day dosing of GH001 on the severity of depression.
    Secondary Objective(s): The secondary objectives of the study are to assess the safety and tolerability of single-day dosing of GH001 in patients with TRD and its effects on the severity of depression, other measures of depression, and on dose-related psychoactive effects.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients meeting the following criteria will be included into the administration phase, unless they fulfil one or more of the exclusion criteria:
    1. Is male or female and in the age range between 18 and 64 years (inclusive);
    2. Has a body mass index (BMI) in the range of 18.5 and 35.0 kg/m2 (inclusive);
    3. Meets the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) diagnostic criteria for single-episode major depressive disorder (MDD) or recurrent MDD, without psychotic features confirmed by the Mini-International Neuropsychiatric Interview (MINI);
    4. Has treatment-resistant depression as assessed using the Antidepressant Treatment History Form – Short Form (ATHF-SF)
    5. Female patients of childbearing potential must be either surgically sterile (hysterectomy, tubal ligation, or bilateral oophorectomy) or postmenopausal with amenorrhea for the last 2 years or use a highly effective (failure rate <1%) medically accepted contraceptive method during the investigational period;
    6. Has outpatient status at screening and enrolment visits
    E.4Principal exclusion criteria
    1. Has received any investigational medication within the last 1 month;
    2. Has known allergies or hypersensitivity or any other contraindication to 5-MeO-DMT;
    3. Has a current medically significant condition (e.g., severe infection) or has a history of a medically significant condition (e.g., medical history of seizure, uncontrolled hypertension, uncontrolled diabetes, severe cardiovascular disease, hepatic or renal failure, etc.) that renders the patient unsuitable for the study according to the medical supervisor’s judgment;
    4. Takes any medication or other substance that renders the patient unsuitable for the study according to the medical supervisor’s judgment;
    5. Has a clinically significant abnormality in physical examination, vital signs, ECG, or clinical laboratory parameters which renders the patient unsuitable for the study according to the medical supervisor’s judgment
    E.5 End points
    E.5.1Primary end point(s)
    Phase 1 (Part A):
    - The safety and tolerability of GH001 administered via inhalation as evaluated by a panel of measures
    Phase 2 (Part B):
    - The effect of GH001 on the severity of depression, as evaluated by mean change in MADRS total score
    E.5.1.1Timepoint(s) of evaluation of this end point
    up to 7 days
    E.5.2Secondary end point(s)
    Phase 1 (Part A):
    - The effect of GH001 on the severity of depression, as evaluated by mean change in MADRS total score
    Phase 2 (Part B):
    - The safety and tolerability of GH001 administered via inhalation as evaluated by a panel of measures
    E.5.2.1Timepoint(s) of evaluation of this end point
    up to 7 days
    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 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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Qualification of doses from healthy volunteers in patients
    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 No
    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 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 months8
    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: 16
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state16
    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 Decision2019-07-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-08-21
    P. End of Trial
    P.End of Trial StatusOngoing
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