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    Summary
    EudraCT Number:2019-001621-27
    Sponsor's Protocol Code Number:201900242
    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:2020-11-22
    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 number2019-001621-27
    A.3Full title of the trial
    A pilot study on oral s-ketamine for depression and demoralization in patients with advanced cancer receiving palliative care
    Pilotstudie naar het effect van orale Esketamine op depressie en demoralisatie bij patiënten met gevorderde kanker die palliatieve zorg ontvangen
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study on ketamine as a treatment for depression and demoralization in patients with advanced cancer
    Een studie naar het effect van ketamine als behandeling voor depressie en demoralisatie bij patiënten met gevorderde kanker
    A.4.1Sponsor's protocol code number201900242
    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 supportUniversity Medical Center Groningen
    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
    B.5.2Functional name of contact pointComprehensive Cancer Center
    B.5.3 Address:
    B.5.3.1Street AddressHanzeplein 1
    B.5.3.2Town/ cityGroningen
    B.5.3.3Post code9713GZ
    B.5.3.4CountryNetherlands
    B.5.4Telephone number00310503611184
    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 Ketanest-S
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer bv
    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 Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNESKETAMINE
    D.3.9.1CAS number 33643-46-8
    D.3.9.4EV Substance CodeSUB25825
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.33
    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
    Depressie
    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.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluation of the feasibility of a randomized controlled trial (RCT) on the efficacy of oral s-ketamine in the treatment of depression and/or demoralization in patients with advanced cancer who receive palliative care.
    Bepalen van de haalbaarheid van een randomized controlled trial (RCT) naar de effectiviteit van orale s-ketamine in de behandeling van depressie en/of demoralisatie bij patiënten met gevorderde kanker die palliatieve zorg ontvangen.
    E.2.2Secondary objectives of the trial
    To examine whether oral S-ketamine will reduce self-reported symptoms of depression in patients with advanced cancer, reduce anxiety levels in depressed patients with advanced cancer, reduce the severity of death anxiety in depressed patients with advanced cancer and improve quality of life in depressed patients with advanced cancer. Furthermore, patients' experience (regarding study procedures and oral s-ketamine treatment) during the study will be qualitatively explored.
    Onderzoeken of orale Esketamine bij patiënten met gevorderde kanker: symptomen van depressie vermindert, (doods)angst vermindert en de kwaliteit van leven verbetert. Verder worden de ervaringen van patiënten tijdens het onderzoek kwalitatief onderzocht.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Male or female;
    • Older than 18 years of age;
    • Good understanding of spoken and written Dutch;
    • DSM-5 diagnosis of MDD, first or recurrent episode, ascertained by the Mini International Neuropsychiatry Interview (MINI-plus) and/or demoralization as indicated by a score of 30 on the Demoralization Scale;
    • Advanced malignancy with no curative antitumor treatment possibilities as determined by a physician at the oncology department.
    - Mannen en vrouwen
    - In de leeftijd van 18 jaar en ouder
    - Goede beheersing van de Nederlandse taal
    - Een DSM-5 diagnose 'major depressive disorder' en/of demoralisatie volgens de Demoralization Scale
    - Gevorderde kanker waarbij geen curatieve behandelopties meer mogelijk zijn, zoals beoordeeld door een arts van de afdeling Medische Oncologie van het UMCG
    E.4Principal exclusion criteria
    - Depression with psychotic features, according to the DSM-5;
    - Previous or comorbid schizophrenia spectrum or other psychotic disorder according to the DSM-5, not including previous MDD with psychotic features;
    - Comorbid moderate or severe dependence of alcohol or drugs according to the DSM-5, not including tobacco-related and caffeine-related disorders;
    - Comorbid delirium, according to the DSM-5;
    - Recent (within the last 4 weeks) or current use of non-prescribed psychoactive compounds, including cannabis and Saint John’s wort;
    - Electroconvulsive therapy (ECT) sessions or antidepressant treatment changes planned for the period of the study;
    - Current use of benzodiazepines and benzodiazepine-like agents (zolpidem, zopiclone) in excess of 2 mg lorazepam or an equivalent per day;
    - Current use of ketamine;
    - Mental incompetence to provide informed consent;
    - In patients with seizures;
    - Presence of any contra-indication for ketamine use. Ketamine is contra-indicated in persons with uncontrolled blood pressure, persons whom have shown hypersensitivity to the drug or its components, in persons with eclampsia or pre-eclampsia, severe coronary or myocardial disease, or a cerebrovasculair accident or cerebral trauma, and in patients who use medication that ketamine interacts with on a major level, such as monoamine oxidase inhibitors (MAOi).
    - Inability to comply with treatments and/or assessments.
    - Depressie met psychotische kenmerken
    - In het verleden of huidig schizofrenie-spectrum stoornis of andere psychotische stoornis volgens de DSM-5, met uitzondering van een depressie met psychotische kenmerken in het verleden.
    - Comorbide alcohol of drugs afhankelijkheid volgens de DSM-5
    - Comorbide delirium
    - Recent (binnen de afgelopen 4 weken) of huidig gebruik van niet-voorgeschreven psychoactieve middelen, waaronder cannabis en St Janskruid.
    - Elektroconvulsieve therapie (ECT) of veranderingen in de behandeling met antidepressiva welke gepland zijn gedurende de studie;
    - Huidig gebruik van benzodiazepines en benzodiazepine-achtige stoffen groter dan 2 mg lorazepam of een equivalent per dag;
    - Huidig gebruik van ketamine;
    - Mentaal gezien niet in staat zijn om geïnformeerde toestemming te geven;
    - Patiënten met epileptische aanvallen
    - Aanwezigheid van contra-indicaties voor ketaminegebruik
    E.5 End points
    E.5.1Primary end point(s)
    The primary objective of this trial is to assess the feasibility of a future randomized controlled trial (RCT) on the efficacy of oral S-ketamine in decreasing depression and demoralization severity in patients with advanced, non-curable cancer.
    • Feasibility will be judged based on safety, tolerability and acceptability as indicated by (1) greater than 80% of significant adverse effects resolving within 120 minutes of each administration, (2) less than 20% dropout rate secondary to adverse effects and (3) feedback from participants regarding treatment sessions and assessments.
    • Efficacy is defined as a clinically important reduction of symptoms (defined as  50% reduction in HDRS17 score and/or  50% reduction in DS score) in at least 30% of participants who commenced treatment.
    Eerste aanwijzingen voor effectiviteit van de interventie, gedefinieerd als een klinisch waardevolle vermindering van depressie en/of demoralisatie bij ten minste 30% van de deelnemers die gestart zijn met de behandeling. Haalbaarheid van de interventie wordt beoordeeld op basis van veiligheid, tolerantie en aanvaardbaarheid, zoals aangetoond door (1) meer dan 80% van de belangrijke bijwerkingen verdwijnen binnen 120 minuten na elke ketaminetoediening, (2) minder dan 20% van de deelnemers stopt met deelname door bijwerkingen, en (3) feedback van de deelnemers over de behandel- en onderzoeksessies en assessments.
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 months after the first inclusion OR after the 10th included participant has completed the study.
    12 maanden na de eerste inclusie OF nadat de 10e geïncludeerde deelnemer de studie heeft afgerond.
    E.5.2Secondary end point(s)
    The secondary objectives of this trial, as described in chapter 2, will be measured by the following secondary study endpoints:
    • Decrease in self-reported depression severity, as expressed by a decrease in total score on the Beck Depression Inventory (BDI);
    • Changes in patients’ quality of life, as expressed by a decrease in total score on the McGill Quality of Life Questionnaire (MQOL);
    • Decrease in anxiety, expressed as a decrease in total score on the:
    - Hospital Anxiety and Depression Scale (HADS) anxiety subscale;
    - Death and Dying Distress Scale (DADDS);
    • Subjective experiences of participants during the trial, as assessed by in-depth, semi-structured interviews.
    • Vermindering in gerapporteerde ernst van depressie, zoals uitgedrukt door een vermindering in de totale score op de Beck Depression Inventory (BDI);
    • Verandering (verbetering) in de kwaliteit van leven, zoals uitgedrukt in een vermindering van de totale score op de McGill Quality of Life Questionnaire (MQOL);
    • Vermindering van angst, zoals uitgedrukt in een vermindering van de totale score op de Hospital Anxiety and Depression Scale (HADS) angst subschaal en de Death and Dying Distress Scale (DADDS);
    • Subjectieve ervaringen van deelnemers tijdens het onderzoek, welke worden uitgevraagd door middel van semigestructureerde diepte-interviews.
    E.5.2.1Timepoint(s) of evaluation of this end point
    12 months after the first inclusion OR after the 10th included participant has completed the study.
    12 maanden na de eerste inclusie OF nadat de 10e geïncludeerde deelnemer de studie heeft afgerond.
    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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 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 end of the study will be 12 months after the first inclusion OR after the 10th inclusion has completed the study.
    The study will be terminated prematurely in case of change in the risk profile of ketamine, making it necessary to re-assess the use of the investigational product. This means that the study is terminated if severe adverse events occur that require medical attention, and that to a certain degree of probability are a harmful and undesirable reaction to ketamine.
    Het einde van de studie is 12 maanden na de eerste inclusie OF nadat de 10e inclusie de studie heeft afgerond.
    De studie kan prematuur worden beëindigd in het geval dat er een verandering in het risicoprofiel van ketamine optreedt, wat het nodig maakt om een her-evaluatie te doen van het middel. Dat betekent dat de studie wordt beëindigd als er serieuze bijwerkingen optreden die medische aandacht vragen, en die mogelijk schadelijk en onwenselijk zijn.
    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 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: 10
    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 Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state10
    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
    None
    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 Decision2021-02-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-09-17
    P. End of Trial
    P.End of Trial StatusOngoing
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