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    Summary
    EudraCT Number:2013-000952-17
    Sponsor's Protocol Code Number:NT13403
    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:2013-03-12
    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 number2013-000952-17
    A.3Full title of the trial
    The Role of mTOR (Mammalian Target of Rapamycin) Signaling Pathway in the Antidepressive Effect of Ketamine in Patients with Depressive Disorder.
    Uloha mTOR (mammalian target or rapamycin) signalni drahy v antidepresivnim ucinku ketaminu u pacientu s depresivni poruchou.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The Role of mTOR (Mammalian Target of Rapamycin) Signaling Pathway in the Antidepressive Effect of Ketamine in Patients with Depressive Disorder.
    Uloha mTOR (mammalian target or rapamycin) signalni drahy v antidepresivnim ucinku ketaminu u pacientu s depresivni poruchou.
    A.3.2Name or abbreviated title of the trial where available
    D-KET-mTOR
    A.4.1Sponsor's protocol code numberNT13403
    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 SponsorPrague Psychiatric Centre
    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 supportInternal Grant Agency Ministry of Health
    B.4.2CountryCzech Republic
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPrague Psychiatric Centre
    B.5.2Functional name of contact pointprincipal investigator
    B.5.3 Address:
    B.5.3.1Street AddressUstavni 91
    B.5.3.2Town/ cityPraha 8 - Bohnice
    B.5.3.3Post code18103
    B.5.3.4CountryCzech Republic
    B.5.4Telephone number+4202660003364
    B.5.5Fax number+420266003366
    B.5.6E-mailsos@pcp.lf3.cuni.cz
    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.3.1Product nameketamine hydrochloride
    D.3.2Product code 05/140/97-C
    D.3.4Pharmaceutical form Infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboInfusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    1. Men and women at the age between 18 to 65 years, with dextromanual dominance.
    2. Patients have to answer DSM IV criteria for the major depressive episode, without psychotic symptoms, on the clinical investigation basis, by Mini international neuropsychiatry interview.
    3. Input score in MADRS Scale higher than 20, what matches medium severity of clinical state in CGI scale higher or equal with 4.
    4. Mental ability to understand and sign informed consent.
    E.1.1.1Medical condition in easily understood language
    Men and women at the age between 18 to 65 years, with dextromanual dominance. Patients have to answer criteria for the major depressive episode, without psychotic symptoms.
    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 14.1
    E.1.2Level PT
    E.1.2Classification code 10012378
    E.1.2Term Depression
    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
    The aim of the trial is to answer the question whether the group of ketamine responders differs from ketamine non-responders:
    a) in the activation of mTOR,
    b) in the anatomical and functional parameters of the brain (before infusion),
    c) in the morphological and functional changes induced by ketamine.
    E.2.2Secondary objectives of the trial
    The evaluation of the mTOR pathway in patients with depression could be predictor of the effectiveness of ketamine infusion.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Men and women at the age between 18 to 65 years, with dextromanual dominance, t.j. scores 100 in Edinburgh Handedness Inventory (EHI).
    2. Patients have to answer DSM IV criteria for the major depressive episode, without psychotic symptoms, on the clinical investigation basis, by Mini international neuropsychiatry interview (M.I.N.I., Czech version 5.0.0.) - structured interview for psychiatric disorders on axis I based on DSM- IV.
    3. Input score in MADRS (Montgomery-Asberg Depression Rating Scale) higher than 20, what matches medium severity of clinical state in CGI (ClinicalGlobal Impression ) scale higher or equal with 4.
    4. Mental ability understand and sign informed consent.
    E.4Principal exclusion criteria
    1. Increased vulnerability to the development of psychosis ascertained on the basis a) M.I.N.I., b) family anamnesis of psychosis at relatives I. and II. degree.
    2. Presence of another psychiatric disorder on axis I base on DSM- IV less than 6 months before inclusion to the study.
    3. Contraindication for ketamine administration (hypertension, heart defect, severe cardiovascular disease, cerebrovascular accident in anamnesis, intracranial hypertension, glaucoma, hyperthyreosis, convulsions in anamnesis).
    4. Using of drugs with strong anticholinergic efect.
    5. Pregnant women, breastfeeding women or women without appropriate contraception.
    6. Electroconvulsive treatment in the last 2 months before visit 1.
    7. Treatment augmentation by lamotrigine, lithium, clozapine or IMAO (inhibitor of monoaminooxidase) in the last 2 weeks before visit 1.
    8. Pharmaceuticals, illness and states, which may have influence on EEG (benzodiazepines, classical antipsychotics, head injury, encephalitis, epilepsy, etc.).
    9. Clinically assessed serious suicidal risk.
    E.5 End points
    E.5.1Primary end point(s)
    The working hypothesis:
    H0A. mTOR activity after the ketamine infusion is not different compared to the activity after the placebo infusion.

    H0B. mTOR activity does not differ between responders and non-responders to ketamine (definition of response: ≥ 50% reduction in MADRS score on at least one of the two assessments - 1st day after infusion or 4th day after infusion).

    H0C. The proportion of subjects with increased activity of mTOR does not differ between responders and non-responders.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The working hypothesis:
    H0A. mTOR activity two hours and 24 hours after the ketamine infusion is not different compared to the activity two hours and 24 hours after the placebo infusion.

    H0B. mTOR activity does not differ between responders and non-responders to ketamine two hours and 24 hours after the infusion (definition of response: ≥ 50% reduction in MADRS score on at least one of the two assessments - 1st day after infusion or 4th day after infusion).

    H0C. The proportion of subjects with increased activity of mTOR does not differ between responders and non-responders two hours and 24 hours after the ketamine infusion.
    E.5.2Secondary end point(s)
    H0D. The changes in functional brain connectivity measured by eLORETA does not differ between responders and non-responders in ventromedial frontal cortex, including the orbitofrontal cortex and subgenual cingulate after the administration of single ketamine infusion.
    E.5.2.1Timepoint(s) of evaluation of this end point
    H0D. The changes in functional brain connectivity measured by eLORETA does not differ between responders and non-responders in ventromedial frontal cortex, including the orbitofrontal cortex and subgenual cingulate, 30 min and 24 h after the administration of single ketamine infusion.
    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 No
    E.6.4Safety No
    E.6.5Efficacy No
    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 Yes
    E.6.13.1Other scope of the trial description
    Response prediction
    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 Yes
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind Yes
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over Yes
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    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 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
    Definition of the end of the trial and justification in the case where it is not the last visit of the the last subject undergoing the trial is provided in the protocol.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    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: 30
    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 state30
    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)
    Treatment of subject after his/her ending participation in the trial will proceed as a normal treatment according to the clinical guidelines.
    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 Decision2013-04-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-04-29
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-12-31
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