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    Summary
    EudraCT Number:2015-004745-70
    Sponsor's Protocol Code Number:55438
    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:2018-08-02
    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 number2015-004745-70
    A.3Full title of the trial
    Efficacy of intranasal ketamine on acute suicidality, a double blind randomized placebo-controlled trial
    (Ketamine Trial Amsterdam, KETA)
    Effectiviteit van intranasale ketamine op acute suïcidaliteit, een dubbelblinde gerandomiseerde placebo-gecontroleerde trial (Ketamine Trial Amsterdam, 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 behaviour
    Effectiviteit van ketamine-neusspray op acute suïcidale gedachten en gedrag
    A.3.2Name or abbreviated title of the trial where available
    Ketamine Trial Amsterdam, (KETA)
    Ketamine Trial Amsterdam, (KETA)
    A.4.1Sponsor's protocol code number55438
    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 SponsorAcademic Medical Center (AMC)
    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 supportAcademic Medical Center
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAcademic Medical Center
    B.5.2Functional name of contact pointJurriaan Strous
    B.5.3 Address:
    B.5.3.1Street AddressMeibergdreef 9
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1100DD
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031655821326
    B.5.6E-mailj.f.strous@amc.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.2.1.1.1Trade name Ketalar
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer limited
    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.3.1Product nameketalar
    D.3.4Pharmaceutical form Nasal spray, solution in single-dose container
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntranasal use (Noncurrent)
    Nasal 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
    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
    Primary Objective
    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
    - the safety,
    - the antidepressant effects,
    - time-course of the effects
    - find neurobiological markers that predict and are associated with the response to ketamine using
    o hippocampal magnetic resonance spectroscopy (MRS)
    o structural connectivity using diffusion tensor imaging (DTI)
    o functional connectivity using magnetic resonance imaging (fMRI)
    o Blood samples
    het onderzoeken van
    - de veiligheid
    - het antidepressieve effect
    - het tijdsverloop van de efecten
    - het vinden van neurobiologische markers die de respons op ketamine voorspellen en/of daarmee geassocieerd zijn.

    - het uitvoeren van hippocampaal magnetic resonance spectroscopy (MRS)
    - het verrichten van structureel connectiviteitsonderzoek met diffusion tensor imaging (DTI)
    - het onderzoeken van functionele connectiviteit middels functionele magnetic resonance imaging (fMRI)
    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 18-70
    acute suïcidaliteit
    een BSSI-score van 7 of hoger
    Proefpersonen zijn 18 tot 70 jaar oud.
    E.4Principal exclusion criteria
    -Psychosis
    -A diagnosis of schizophrenia or another psychotic disorder
    -A history of PCP- or ketamine addiction
    -Being under influence of GHB
    -A blood alcohol concentration (BAC)of >0.05%
    -A clinically significant and unstable cardiovascular, gastro-intestinal, pulmonal, renal, hepatic, endocrine or haematological disorder, a myocardial infarction, miction problems or a complex surgical problem that needs immediate attention
    -A known hypersensitivity for ketamine
    -Concomitant use of seligiline
    -Severe nose congestion or nasal polyps
    -Pregnancy or giving breastfeeding
    -Women using unreliable contraception
    -Being unable to answer the questionnaires
    -Being unwilling or unable to provide informed consent
    -Earlier participation in this study
    -Psychose
    -Een diagnose van schizofrenie of een andere psychotische stoornis
    -Een geschiedenis van PCP- of ketamineverslaving/misbruik
    -Onder invloed zijn van GHB
    -Een bloed alcohol concentratie (BAC) van >0,05%
    -Een klinisch significante en onstabiele cardiovasculaire, gastro-intestinale, pulmonale, renale, hepatische, endocriene of hematologische stoornis, een myocardinfarct, mictieproblemen of een complex chirurgisch probleem dat onmiddellijke medische aandacht behoeft.
    -Een bekende hypersensitiviteit voor ketamine.
    -Gelijktijdig gebruik van seligiline
    -Ernstige neusverstopping of neuspoliepen
    -Zwangerschap of het geven van borstvoeding
    -Vrouwen die geen betrouwbare anticonceptie gebruiken.
    -Niet in staat zijn vragenlijsten in te vullen/te beantwoorden
    -Niet willen of niet in staat zijn tot het geven van informed consent
    -Eerdere deelname aan de studie.
    E.5 End points
    E.5.1Primary end point(s)
    Change in suicidality scores on the BSSI between baseline and 180 minutes after 50 mg intranasal ketamine administration compared to 4.5 mg 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 4,5mg intranasale midazolam.
    E.5.1.1Timepoint(s) of evaluation of this end point
    180 minutes
    180 minuten
    E.5.2Secondary end point(s)
    1. Acute 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)
    b. Sheehan Suicidality Tracking Scale (SSTS)
    c. Suicidality item on the Montgomery Asberg Depression Rating Scale. (MADRS).
    2. Actual number of suicides and suicidal acts in both groups.
    3. Depressive symptoms as measured with the MADRS from baseline to 60 minutes and 180 minutes, one day, three days and one week after one intranasal ketamine administration compared to placebo (34).
    4. Psychotomimetic symptoms, as measured with the Brief Psychiatric Rating Scale – Positive Subscale (BPRS) from baseline to 60 minutes and 180 minutes.
    5. Change in BDNF concentration, genetics and other biomarkers. A blood sample of 5ml will be taken by venepuncture into vacuum tubes containing ethylene diamine tetraacetic acid (EDTA) and be transferred into a heparinised tube, at baseline and at 180 minutes after ketamine/midazolam administration.
    1. Acute suïcidaliteit ten opzichte van baseline op 60 minuten, 180 minuten, één dag, drie dagen en één week na toediening van intranasale ketamine in vergelijking met placebo, gemeten met
    -de BSSI
    -de Sheehan Suicidality Tracking Scale (SSTS)
    -het suïcidaliteitsitem op de Montgomery Asberg Depression Rating Scale (MADRS).
    2. Het aantal suïcides in beide groepen.
    3. Depressieve symptomen als gemeten met de MADRS t.o.v. baseline op 60 minuten, 180 minuten, 1 dag, 3 dagen en 1 week na toediening van de intranasale ketamine.
    4. Psychotomimetische symptomen als gemeten met de Brief Psychiatric Ratings Scale, Positive Subscale (BPRS-PS) t.o.v. baseline op 60 en 180 minuten na toediening.
    5. Verandering in BDNF-concentratie, genetica en andere biomarkers. Middels venapunctie zal een bloedmonster van 5ml afgenomen worden in een met ethylene diamine tetraacetic acid (EDTA). Dit zal vervolgens in een gehepariniseerde buis overgebracht worden. Dit zal net voor de toediening en 180 minuten na de toediening van de ketamine dan wel de midazolam gebeuren.
    6. Structural MRI, functional MRI (fMRI), diffusion tensor imaging (DTI), H-MRS-analysis of glutamate in hippocampus and prefrontal cortex. Subjects that were administered ketamine will be compared to subjects that were administered midazolam, at one day after administration.
    7. A responder/non responder analysis. (Response is defined as a 50% reduction in BSSI-score).
    E.5.2.1Timepoint(s) of evaluation of this end point
    60 minutes, 180 minutes, 1 day, 3 days and 1 week after ketamine administration
    60 minuten, 180 minuten, 1 dag, 3 dagen en 1 week na ketaminetoediening
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    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 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
    The last follow-up call of the last subject (one week after his/her visit)
    Het laatste telefoontje naar de laatst geïncludeerde proefpersoon (1 week 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
    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: 110
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 18
    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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    The population to be studied consists of acutely suicidal patients.
    De te onderzoeken populatie bestaat uit acuut suïcidale patiënten.
    F.4 Planned number of subjects to be included
    F.4.1In the member state128
    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)
    Patients will recieve care as usual for acute suicidality after the trial.
    Patiënten zullen na voltooiing van de trial de voor acute suïcidaliteit gebruikelijke zorg ontvangen.
    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 Decision2018-11-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-07-23
    P. End of Trial
    P.End of Trial StatusOngoing
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