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    Summary
    EudraCT Number:2021-006510-36
    Sponsor's Protocol Code Number:NL79264.091.21
    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:2021-12-21
    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 number2021-006510-36
    A.3Full title of the trial
    Exploring the Pharmacomicrobiomics of Depression
    Verkennen van de farmacomicrobiomics van depressie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Exploring the relationship between gut microbiota and the efficacy of antidepressant treatment in patients with depression
    Verkennen van de relatie tussen darmbacteriën en de effectiviteit van behandeling met antidepressiva in patiënten met depressie
    A.3.2Name or abbreviated title of the trial where available
    Pharma-biome
    farma-bioom
    A.4.1Sponsor's protocol code numberNL79264.091.21
    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 SponsorRadboudumc
    B.1.3.4CountryNetherlands
    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 supportRadboudumc
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRadboudumc
    B.5.2Functional name of contact pointMirjam Bloemendaal
    B.5.3 Address:
    B.5.3.1Street AddressReinier Postlaan 10
    B.5.3.2Town/ cityNijmegen
    B.5.3.3Post code6525GC
    B.5.3.4CountryNetherlands
    B.5.6E-mailMirjam.Bloemendaal@radboudumc.nl
    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 Yes
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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.3.4Pharmaceutical 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Major Depressive Disorder
    Major Depressive Disorder
    E.1.1.1Medical condition in easily understood language
    Depression
    Depressie
    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 10081270
    E.1.2Term Major depressive disorder
    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 objective of this project is to associate the gut microbial community with treatment efficacy (i.e., relieve in symptoms and side effects) in patients with suspected treatment-resistant depression.
    Het hoofddoel van dit project is om de samenstelling van het darm microbioom in verband te brengen met de doeltreffendheid van antidepressiva (d.w.z., verlichting van symptomen en bijwerkingen) bij patiënten met een depressie.
    E.2.2Secondary objectives of the trial
    The secondary objective of this project is to clarify the role of drug metabolism and absorption in the association between the gut microbial community and treatment efficacy.
    Het secundaire doel van de studie het het verduidelijken van de rol van het metabolisme en de absorptie van antidepressiva in de associatie tussen het darm microbioom en de doeltreffendheid van de behandeling
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Aged ≥ 18
    Main diagnosis of unipolar depression
    Indication for the prescription of an antidepressant
    Starting a new SSRI/SNRI or TCA antidepressant treatment
    Having already used one or more antidepressants without effect and/or with side-effects
    Leeftijd ≥ 18
    Hoofddiagnose unipolaire depressie
    Indicatie voor het voorschrijven van een antidepressivum
    Start met een nieuw SSRI/SNRI of TCA antidepressiva behandeling
    Reeds 1 óf meer antidepressiva gebruikt zonder effect en/of met bijwerkingen
    E.4Principal exclusion criteria
    Use of antibiotics in a period of three months prior to the baseline visit
    Currently pregnant or breastfeeding
    Gebruik van antibiotica in een periode van drie maanden voorafgaand aan de baseline visite
    Zwanger of geeft borstvoeding
    E.5 End points
    E.5.1Primary end point(s)
    Treatment efficacy is assessed based on questionnaires that are filled out as a part of regular treatment, and is defined as:
    1. The change in depression score from baseline to follow-up (measured using Hamilton Rating Scale for Depression)
    2. The experienced side effects at follow-up (measured using antidepressant Side-Effect Checklist)

    Gut microbiota community, defined as
    1. The change in alpha and beta gut microbial diversity
    2. The difference in microbial relative abundance
    Doeltreffendheid van de behandeling wordt gekwantificeerd door middel van vragenlijsten die ingevuld worden als onderdeel van de reguliere zorg, en wordt gedefinieerd als:
    1. Het verschil in depressie score van baseline tot follow-up (Hamilton Rating Scale for Depression)
    2. De ervaren bijwerkingen tijdens follow-up (measured using antidepressant Side-Effect Checklist)

    De samenstelling van de darmbacteriën, gedefinieerd als
    1. De veranderingen in alfa en beta diversiteit
    2. De veranderingen in microbiële relatieve hoeveelheid
    E.5.1.1Timepoint(s) of evaluation of this end point
    At baseline, prior to starting a new antidepressant (symptoms)
    At follow-up, approximately six weeks after initiating the new medication (symptoms and side-effects)
    Tijdens de baseline, voorafgaand aan het starten met een nieuw antidepressivum (symptomen)
    Tijdens de follow-up, ongeveer zes weken na de start met een nieuw antidepressivum (symptomen en bijwerkingen)
    E.5.2Secondary end point(s)
    Therapeutic medication levels, determined in the blood plasma
    Therapeutische medicatie levels, gemeten in het bloedplasma
    E.5.2.1Timepoint(s) of evaluation of this end point
    At follow-up, approximately six weeks after initiating the new medication
    Tijdens de follow-up, ongeveer zes weken na de start met een nieuw antidepressivum
    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 No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    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
    Observationele longitudinale studie
    Observational longitudinal study
    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
    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 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: 25
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 999
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2021-12-21. Yes
    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 state25
    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)
    The study is performed in the context of regular care. Treatment will follow the regular hospital protocol and will, as such, be continued after the trial ends.
    De studie wordt uitgevoerd in het kader van de reguliere zorg. De behandeling zal de reguliere ziekenhuisprotocollen volgen, en zal als zodanig worden voortgezet na het beëindigen van de studie.
    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 Decision2021-12-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-12-20
    P. End of Trial
    P.End of Trial StatusOngoing
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