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    Summary
    EudraCT Number:2020-002905-24
    Sponsor's Protocol Code Number:74304
    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:2021-06-10
    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 number2020-002905-24
    A.3Full title of the trial
    Efficacy and feasibility of intranasal ketamine on acute suicidality, a double blind
    randomized placebo-controlled trial
    (Ketamine Trial for Acute suicidalty, KETA)
    Effectiviteit en toepasbaarheid van intranasale ketamine op acute suïcidaliteit, een
    dubbelblinde gerandomiseerde placebo-gecontroleerde trial (Ketamine
    Trial voor Acute suicidaliteit, KETA)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy of ketamine nose-spray on acute suicidal thoughts and behaviou
    Effectiviteit van ketamine-neusspray op acute suïcidale gedachten en
    gedrag
    A.3.2Name or abbreviated title of the trial where available
    Ketamine Trial for Acute suicidality (KETA)
    Ketamine Trial voor Acute suïcidaliteit (KETA)
    A.4.1Sponsor's protocol code number74304
    A.5.4Other Identifiers
    Name:research register UMCGNumber:202000511
    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 SponsorUniversity Medical Center Groningen
    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 supportZonMw
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Medical Center Groningen (UMCG
    B.5.2Functional name of contact pointJurriaan Strous
    B.5.3 Address:
    B.5.3.1Street AddressHanzeplein 1
    B.5.3.2Town/ cityGroningen
    B.5.3.3Post code9713 AG
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031503616161
    B.5.5Fax numberNeder655821326
    B.5.6E-mailjurriaanstrous@gmail.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.3.1Product nameketamine/ketalar
    D.3.2Product code 1867-66-9
    D.3.4Pharmaceutical form Nasal spray, solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPNasal 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 placeboNasal spray, solution
    D.8.4Route of administration of the placeboNasal use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Acute suicidality, which is a rapid increase in suicidal ideation or
    behaviour from the patient's 'baseline' in the last 24 hours.
    Acute suïcidaliteit, gedefinieerd als een snelle toename in suïcidale
    gedachten of gedrag vanaf de 'baseline' van patiënt.
    E.1.1.1Medical condition in easily understood language
    Acute suicidality, thoughts about the wish to kill oneself, or behaviour with either the aim to die or a significant likelyhood that one could die because of this behaviour
    Acute suïcidaliteit, gedachten over de wens zichzelf van het leven te
    willen beroven, of gedrag met het doel te sterven of met een grote
    waarschijnlijkheid dat men als gevolg van het gedrag sterft.
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Mental Disorders [F03]
    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 investigate the anti-suicidal effects of a single dose of intranasal
    ketamine in acutely suicidal subjects.
    Het onderzoeken van het antisuïcidale effect van een eenmalige dosering van intranasale ketamine in acuut suïcidale proefpersonen.
    E.2.2Secondary objectives of the trial
    to assess
    -safety
    -antidepressant effects
    -time-course of the effects
    -the number of suicides and suicidal acts
    -the pharmacokinetic profile of intranasal ketamine
    -the association between the anti-suicidal and the antidepressant effect
    -neurobiological markers associated with the response to ketamine using
    *structural magnetic resonance imaging (MRI)
    *hippocampal and prefrontal magnetic resonance spectroscopy (MRS)
    *structural connectivity using diffusion tensor imaging (DTI)
    *functional connectivity using magnetic resonance imaging (fMRI)
    *blood samples
    -het vaststellen van
    - veiligheid
    - het antidepressieve effect
    - het tijdsverloop van het effect
    - het aantal suïcides en suïcidepogingen
    - het farmacokinetische profiel van intranasale ketamine
    - het verband tussen het antisuïcidale en het antidepressieve effect
    - neurobiologische markers geassocieerd met de respons op ketamine gemeten middels
    *MRI
    *hippocampale en prefrontale MRS
    *structurele connectiviteit gemeten middels DTI
    *functionele connectiviteit als gemeten met fMRI
    *bloedsamples
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Acute suicidality
    A Beck Scale for Suicide Ideation (BSSI)-score of 7 or above
    Subjects are in the age of 18-7
    Acute suïcidaliteit
    Een BSSI-score van 7 of hoger
    Proefpersonen zijn 18 tot 70 jaar oud
    E.4Principal exclusion criteria
    1. Earlier participation in this study
    2. Psychosis (as a primary diagnosis) (depression with psychotic features will not be an exclusion criterion per se).
    3. A diagnosis of schizophrenia or another primary psychotic disorder.
    4. A history of PCP- or ketamine addiction.
    5. Being under influence of GHB (Substance abuse in the (recent) history
    is not an exclusion criterion per se (with the exception of GHB and a high
    blood alcohol concentration, and intoxications leading to medical
    unstable conditions).
    6. A blood alcohol concentration (BAC)of >0.05%
    7. A clinically significant and unstable infectious, immunological,
    cardiovascular, gastro-intestinal, pulmonal, renal, hepatic, endocrine or haematological disorder, a myocardial infarction, miction problems or a complex surgical problem that needs immediate attention.
    8. Presence of any contra-indication for ketamine use, such as severe high blood pressure, a recent myocardial infarction or relevant cardiac problems, severe thyroid problems, severe liver problems, severe kidney problems, epilepsy and increased intracranial pressure.
    9. A known hypersensitivity for ketamine.
    10. Concomitant use of a MAO-inhibitor.
    11. Severe nose congestion or nasal polyps.
    12. Pregnancy or giving breastfeeding 13. Women of reproductive age using unreliable contraception.
    14. Being unable to answer the questionnaires
    15. Legal incompetency with regard to participation in this study
    16. No informed consent
    1. Eerdere deelname aan deze studie
    2. Psychose (als primaire diagnose) (depressie met psychotische kenmerken is niet per definitie een exclusiecriterium).
    3. Een diagnose van schizofrenie of een andere primaire psychotische stoornis
    4. Een geschiedenis van PCP- of ketamineverslaving/misbruik
    5. Onder invloed zijn van GHB (middelenmisbruik is niet per se een
    exclusiecriterium, met een GHB-intoxicatie of een BAC van >0,05% of
    een intoxicatie die acute medische interventie vereist als uitzondering).
    6. Een bloed alcohol concentratie (BAC) van >0,05%
    7.Een klinisch significante en onstabiele infectieuze, immunologische,
    cardiovasculaire, gastro-intestinale, pulmonale, renale, hepatische,
    endocriene of hematologische stoornis, een myocardinfarct,
    mictieproblemen of een complex chirurgisch probleem dat onmiddellijke
    medische aandacht behoeft.
    8. Aanwezigheid van een contra-indicatie voor ketaminegebruik, zoals
    een ernstige hoge bloeddruk, een recent myocardinfarct of relevante
    cardiale problemen, ernstige leverproblematiek, ernstige
    nierproblematiek, epilepsie en verhoogde intracraniële druk.
    9. Een bekende hypersensitiviteit voor ketamine.
    10. Gelijktijdig gebruik van een MAO-remmer.
    11. Ernstige neusverstopping of neuspoliepen
    12. Zwangerschap of het geven van borstvoeding
    13. Vrouwen in de vruchtbare leeftijd die geen betrouwbare
    anticonceptie gebruiken.
    14. Niet in staat zijn vragenlijsten in te vullen/te beantwoorden.
    15. Niet wilsbekwaam zijn ten aanzien van het geven van informed consent voor deelname aan de studie.
    16. Geen informed consent
    E.5 End points
    E.5.1Primary end point(s)
    Change in suicidality scores on the BSSI between baseline and 180
    minutes after 75 mg intranasal ketamine administration compared to 4.0mg intranasal midazolam (placebo
    Verandering in acute suïcidaliteit als gemeten met de Beck Scale for
    Suicide Ideation (BSSI), 180 minuten na 50mg intranasale ketamine, ten opzichte van 4,0mg intranasale midazolam
    E.5.1.1Timepoint(s) of evaluation of this end point
    180 minutes after intervention/comparator
    180 minuten na interventie/comparator
    E.5.2Secondary end point(s)
    1. Suicidality from baseline to 60 minutes, 180 minutes, one day, three days and one week after one intranasal ketamine administration compared to placebo, as measured with: a. Beck Scale for Suicide Ideation (BSSI) (Dutch version) c. Suicidality item on the Montgomery
    Asberg Depression Rating Scale. (MADRS) (Dutch version).
    2. Actual number of suicides and suicidal at 60 and 180 minutes, 1, 3 and 7 days after ketamine/midazolam administration.
    3. Depressive symptoms as measured with the MADRS from baseline to 60 minutes and 180 minutes, one, three and seven days after one intranasal ketamine administration compared to placebo.
    4. Clinical severity and improvement as measured with the CGI
    5. Psychotomimetic symptoms, as measured with the SAFTEE (Dutch version) and the CADSS (Dutch version) from baseline to 60 minutes and 180 minutes.
    items 6-11 in protocol
    Suïcidaliteit ten opzichte van baseline op 60 minuten, 180 minuten,
    1,3 en 7 dagen en 6 en 12 maanden na toediening van intranasale
    ketamine in vergelijking met placebo, gemeten met -de BSSI
    (Nederlandse versie) -het suïcidaliteitsitem op de Montgomery Asberg
    Depression Rating Scale (MADRS) (Nederlandse versie)
    2. Het aantal suïcides in beide groepen op 60 en 180 minuten, 1, 3 en 7
    dagen en 6 en 12 maanden na ketamine/midazolamtoediening.
    3. Depressieve symptomen als gemeten met de MADRS t.o.v. baseline op
    60 minuten, 180 minuten, 1, 3 en 7 dagen en 6 en 12 maanden na
    toediening van de intranasale ketamine, in vergelijking met placebo. 4. Klinische ernst en verbetering als gemeten met de CGI
    5. Psychotomimetische symptomen als gemeten met de SAFTEE (Nederlandse versie) en de CADSS (Nederlandse versie) t.o.v. baseline op 60 en 180 minuten na toediening.
    items 6-11 in protocol
    E.5.2.1Timepoint(s) of evaluation of this end point
    60 minutes, 180 minutes, 1,3 and 7 days after
    intervention/comparator
    60 minuten, 180 minuten, 1,3 en 7 dagen na
    toediening van interventie/comparator
    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 Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 concerned2
    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 Yes
    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
    The last follow-up call of the last subject (one week after his/her visit)
    Het laatste telefonisch contact naar de laatst geïncludeerde proefpersoon (1week na inclusie)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial 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: 112
    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 Yes
    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 state112
    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
    Geen
    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 Decision2021-07-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-06-08
    P. End of Trial
    P.End of Trial StatusOngoing
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