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    Summary
    EudraCT Number:2018-001539-39
    Sponsor's Protocol Code Number:NV18-04-00260
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-05-31
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2018-001539-39
    A.3Full title of the trial
    Clinical and neurobiological predictors of response to ketamine: towards personalized treatment of depression
    Klinické a neurobiologické prediktory odpovědi na ketamin jako podklad pro personalizovanou terapii deprese
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study searching for the factors predicting ketamine´s antidepressant effect
    Studie zaměřena na předpověď antidepresivního účinku ketaminu
    A.4.1Sponsor's protocol code numberNV18-04-00260
    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 SponsorNárodní ústav duševního zdraví
    B.1.3.4CountryCzech Republic
    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 supportAZV ČR
    B.4.2CountryCzech Republic
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNárodní ústav duševního zdraví
    B.5.2Functional name of contact pointClinical Trials Information
    B.5.3 Address:
    B.5.3.1Street AddressTopolová 748
    B.5.3.2Town/ cityKlecany
    B.5.3.3Post code250 67
    B.5.3.4CountryCzech Republic
    B.5.5Fax number283088111
    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.2.1.1.1Trade name Calypsol
    D.2.1.1.2Name of the Marketing Authorisation holderGedeon Richter Plc.
    D.2.1.2Country which granted the Marketing AuthorisationCzech Republic
    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 Concentrate and solvent for solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNKetamine
    D.3.9.3Other descriptive nameKETAMINE HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB02830MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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
    Moderate to severe depression without psychotic symptoms
    Středně těžká až těžká deprese bez psychotické symptomatologie
    E.1.1.1Medical condition in easily understood language
    Depression (pathologicaly low mood)
    Deprese (chorobně pokleslá nálady)
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Psychological processes [F02]
    MedDRA Classification
    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 whether ketamine responders differ from non-responders in baseline parameters of anhedonia and to what extent does the change in anhedonia after ketamine administration correlate with the reduce in depressive symptomatology.
    Zjistit, zda se skupina responderů na ketamin liší od non-responderů ve výchozích parametrech anhedonie, vztažených na fenotyp deprese, a do jaké míry změna v anhedonii po podání ketaminu koreluje s depresivní symptomatologií
    E.2.2Secondary objectives of the trial
    To compare baseline plasmatic levels of kynurenine pathway metabolites, D-serine and proinflammatory cytokines between responders and non-responders to ketamine.
    To assess the electrophysiological correlates of ketamine response using eLORETA (Exact Low Resolution Brain Electromagnetic Tomography) and to determine their predictive potential.
    To estimate the influence of several demographic and clinical variables, such as age, sex, anxiety, family history of alcohol abuse, and assess their predictive potential.
    Porovnání výchozích plazmatických hladin metabolitů kynureninové kaskády, D-serinu a vybraných prozánětlivých cytokinů, mezi respondery a non-respondery.
    Sledování potenciálních elektrofyziologických prediktorů pomocí eLORETA (Exact Low Resolution Brain Electromagnetic Tomography).
    Hodnocení vlivu některých demografických proměnných (věk, pohlaví a rodinná anamnéza abusu alkoholu).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Men and women aged 18 to 65 years old
    Moderate to severe depression without psychotic symptoms, current depressive episode at least 4 weeks and no more than 2 years of duration
    MADRS score more than 20, CGI 4 or more
    At least one previous, unsuccessful, adequate treatment for major depression in current episode
    Stable dose of antidepressants for at least 1 month and clinically appropriate to continue during trial
    Mental competence to understand and sign the informed consent
    Muži a ženy ve věku 18 až 65 let
    Nemocní musí splňovat kritéria pro středně těžkou až těžkou depresi bez psychotických příznaků, délka současné epizody minimálně 4 týdny, ne však delší než 2 roky
    Vstupní skóre ve škále MADRS (Montgomery-Åsberg Depression Rating Scale) [Montgomery et al., 1979] vyšší než 20, které odpovídá mírně až středně závažnému klinickému stavu, a ve škále CGI (Clinical Global Impression) [Guy et al., 1976] vyšší nebo rovno 4.
    Minimálně jedna neúspěšná antidepresivní léčba pro danou depresivní epizodu v adekvátní dávce a délce
    Stabilní dávka antidepresiv minimálně po dobu 1 měsíce
    Duševní způsobilost porozumět a podepsat informovaný souhlas.
    E.4Principal exclusion criteria
    Increased vulnerability to psychosis based on a) M.I.N.I. (including past episodes), b) family history of psychosis up to second degree relatives
    The presence of comorbid psychiatric disorder on Axis I within the criteria of ICD 10 F 0.X – F 99.X, except F 32.1-2, F 33.1/2 less than 6 months prior to enrollment in the study, including drug or alcohol addiction or abstinence for less than 2 years
    Substantial suicidal risk as judged by the treating psychiatrist
    Personality disorder that makes participation in the trial difficult
    Somatic contraindications for the administration of ketamine: severe arterial hypertension (WHO stage 2 and above), congestive heart failure or other severe cardiovascular disease, history of stroke, intracranial hypertension, glaucoma, history of preeclampsia or eclampsia, untreated or decompensated thyroid gland disease, history of seizures
    History of autoimmune or rheumatologic disease, undergoing biological therapy, chronic infectious disease or severe acute infection within 2 months prior to the trial
    Concomitant treatment augmentation with lamotrigine, lithium, clozapine or MAOi (monoamine oxidase inhibitor) within the previous 2 weeks before the first visit
    Medications and/or diseases, that can significantly affect EEG (typical antipsychotics, cranial trauma, encephalitis, epilepsy, etc.), history of electroconvulsive treatment in the 2 month prior to infusion and left-handedness
    Pregnancy, breastfeeding or the absence of adequate contraception
    Zvýšená vulnerabilita pro rozvoj psychózy zjištěná na základě a) M.I.N.I., b) rodinné anamnézy psychóz u příbuzných 1. a 2. řádu.
    Přítomnost jiné psychiatrické poruchy na ose I podle DSM-V (MKN 10 F 0.X – F 99.X, kromě F 32.1-2, F 33.1-2) méně než 6 měsíců před zařazením do studie včetně komorbidní závislosti či škodlivého užívání (mimo nikotin) či abstinence kratší než 2 roky.
    Diagnostikovana porucha osobnosti, která by účast v klinickém hodnocení znemožňovala.
    Somatické kontraindikace pro podání ketaminu (arteriální hypertenze 2.stádia dle WHO a výše či dekorigovaná arteriální hypertenze 1.stádia, srdeční vada, těžké kardiovaskulární onemocnění, cévní mozková příhoda v anamnéze, nitrolební hypertenze, glaukom, preeklampsie nebo eklampsie v anamnéze, neléčené nebo nedostatečně substituované onemocnění štítné žlázy, křeče v anamnéze).
    Diagnostikované autoimunitní či revmatologické onemocnění, biologická terapie.
    Chronické infekční onemocnění či prodělaná závažná akutní infekce v posledních 2 měsících.
    Ženy gravidní, kojící a bez adekvátní antikoncepce.
    Augmentace léčby lamotriginem, lithiem, klozapinem nebo IMAO (inhibitorem monoaminooxidázy) v posledních 2 týdnech před vizitou 1.
    Léky, onemocnění a stavy, které mohou výrazně ovlivňovat EEG (klasická antipsychotika, úraz hlavy, encefalitida, epilepsie, atd.) nebo anamnéza elektrokonvulzivní terapie méně než 2 měsíce před zařazením do studie.
    Závažné klinické riziko suicidality u pacienta.
    Sinistralita (levorukost) pacienta
    E.5 End points
    E.5.1Primary end point(s)
    To determine whether ketamine responders differ from non-responders in baseline parameters of anhedonia and to what extent does the change in anhedonia after ketamine administration correlate with the reduce in depressive symptomatology.
    Stanovit zda respondeři na ketamin se liší od nonresponderů ve vstupních parametrech anhedonie a do jaké miry je změna anhedonie po administraci ketaminu koreluje se změnou depresivní symptomatologie.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Anhedonia will be evaluated before ketamine administration (day -1) and after the infusion (day 4). Depressive symptomatology will be evaluated before the infusion (day -1) followed by controls at day 1, day 4 and day 6. Both parameters will be evaluated also during the follow-up visit on day 20.
    Anhedonie bude hodnocena před podáním ketaminu (den -1) a 4.den po infuzi. Depresivní symptomatologie bude hodnocena před podáním ketaminu (den -1) a poté 1., 4., 6.den po podání a během kontrolní follow-up vizity 20.den po administraci ketaminu.
    E.5.2Secondary end point(s)
    1. To compare baseline plasmatic levels of kynurenine pathway metabolites, D-serine and proinflammatory cytokines between responders and non-responders to ketamine.
    2. To assess the electrophysiological correlates of ketamine response using eLORETA (Exact Low Resolution Brain Electromagnetic Tomography) and to determine their predictive potential.
    3. To estimate the influence of several demographic and clinical variables, such as age, sex, anxiety, family history of alcohol abuse, and assess their predictive potential.
    4. To estimate the influence of cognitive processing speed on ketamine response.
    1. Porovnat vstupní plazmatické hladiny metabolite kynureninové kaskády, D-serinu a prozánětlivých cytokinů mezi respondery a nonreapondery na ketamin.
    2. Stanovit elektrofyziologické koreláty odpovědi na ketamin pomocí eLORETA (Exact Low Resolution Brain Electromagnetic Tomography) jejich predikční potenciál.
    3. Sledovat vliv demografických a klinických parametrů jako pohlaví, věk, míra úzkosti, rodinná anamnéza abuzu alkoholu a jejich predikční potenciál.
    4. Sledovat vliv rychlosti kognitivního zpracování na odpověď na ketamin.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Blood samples will be taken before the ketamine infusion (day 0), during the infusion and after the application (at day 4)
    2. EEG will be registered before the ketamine infusion (day 0), during the infusion and after the application (at day 4)
    3. Demographic variables will be evaluated at baseline (day -7 to -2), anxiety will be evaluated before (day -1) and after the infusion (day 1,4,6)
    4. Cognitive processing will be tested before (day -1) and after (day 4) the infusion
    1. Odběry krve budou provedeny před podáním ketaminu (den 0), v průběhu infuze a po aplikaci ketaminu (den 4).
    2. Registrace EEG bude provedena před podáním ketaminu (den 0), v průběhu infuze a po aplikaci ketaminu (den 4).
    3. Demografické parametry budou zaznamenány vstupně (den -7 až -2), míra úzkosti bude hodnocena před podáním ketaminu (den -1) a po infuzi ve dnech 1, 4 a 6.
    4. Kognitivní zpracování bude testováno před podáním ketaminu (den -1) a 4.den po infuzi.
    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 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) 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) Yes
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    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: 40
    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 state40
    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)
    After completing the study (day 20 of the study), the treatment will be entirely directed by the attending physician or, in the case of a patient's discharge from the clinic, under the direction of his outpatient psychiatrist.
    Po kompletním ukončení studie (20.den KH) bude léčba zcela v režii ošetřujícího lékaře na oddělení či, v případě propuštění pacienta, v režii jeho ambulantního psychiatra.
    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 Decision2018-07-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-06-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-04-14
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