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    Summary
    EudraCT Number:2021-003228-34
    Sponsor's Protocol Code Number:OCMDKET
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2022-01-28
    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 ConcernedAustria - BASG
    A.2EudraCT number2021-003228-34
    A.3Full title of the trial
    Ketamine therapy and its effects on stress on neuropsychological function under stress in obsessive-compulsive disorder
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Low dose ketamine and stress-tests in obsessive-compulsive disorder
    A.3.2Name or abbreviated title of the trial where available
    Ketamine and stress in OCD
    A.4.1Sponsor's protocol code numberOCMDKET
    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 SponsorMedical University of Vienna
    B.1.3.4CountryAustria
    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 supportMedical University of Vienna
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDepartement of Psychiatry and Psychotherapy, Medical University of Vienna
    B.5.2Functional name of contact pointChristoph Kraus
    B.5.3 Address:
    B.5.3.1Street AddressWähringer Gürtel 18-20
    B.5.3.2Town/ cityVienna
    B.5.3.3Post code1090
    B.5.3.4CountryAustria
    B.5.4Telephone number+43140400 35930
    B.5.6E-mailchristoph.kraus@muv.ac.at
    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 Ketamin-hameln 50mg/ml Injektionslösung
    D.2.1.1.2Name of the Marketing Authorisation holderhameln pharma plus gmbh Langes Feld 13 31789 Hameln, Deutschland
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameKetamin-hameln 50 mg/ml Injektionslösung
    D.3.4Pharmaceutical form Injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInfusion (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNKETAMINE
    D.3.9.1CAS number 6740-88-1
    D.3.9.4EV Substance CodeSUB08365MIG
    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
    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 placeboInfusion (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Obsessive-compulsive disorder
    E.1.1.1Medical condition in easily understood language
    Obsessive-compulsive disorder
    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 prolonged efficacy of ketamine in alleviating symptoms of patients with OCD (7 days)
    E.2.2Secondary objectives of the trial
    To investigate the prolonged efficacy of ketamine in alleviating symptoms of patients with OCD (24 hours)
    To investigate the prolonged efficacy of ketamine in alleviating symptoms of patients over the course of 7 days. (VAS)
    To investigate the effects of ketamine on neuropsychological function under stress in patients with OCD.
    To investigate the effects of ketamine on hormonal stress response measured by salivary cortisol levels in patients with OCD.
    To investigate the effects of ketamine on vegetative stress response measured by blood pressure and heart rate in patients with OCD.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Primary diagnosis of obsessive-compulsive disorder

    A score of 16 or higher on the Yale-Brown Obsessive Compulsive Scale

    Age of at least 18 years and ability to provide written informed consent

    One previous treatment for OCD
    E.4Principal exclusion criteria
    Any history of current or past psychotic disorder

    A manic episode within the preceding three years

    Current or unstable remitted substance abuse or dependence except nicotine

    Pregnancy or elevated risk of becoming pregnant during study duration (desire to have children) and refusal to utilize a proper method of contraception

    Any current severe personality disorder except comorbid anankastic personality disorder

    Current unstable suicidality

    Morbus Raynaud

    Unstable hypertension

    Any other severe and unstable cardiovascular disease

    Untreated hyperthyroidism

    Untreated disorders severely affecting the HPA-axis (M.Addison, M.Cushing)

    Current pharmacological therapy severely affecting the HPA-axis like corticosteroids or ACTH

    Inability to follow the study protocol or adhere to operational requirements
    E.5 End points
    E.5.1Primary end point(s)
    Significant reduction of symptoms measured by Yale-Brown Obsessive-Compulsive Scale after application of intravenous ketamine
    E.5.1.1Timepoint(s) of evaluation of this end point
    1 and 7 days after each infusion
    E.5.2Secondary end point(s)
    Treatment success for the individual patient, defined as 35% reduction in Y-BOCS scores from baseline.
    Symptom alleviation measured by YBOCS and OCD visual analogue scale score will persist for up to seven days
    Significant reduction of obsessive thoughts after ketamine infusion, measured by OCD visual analogue scale in comparison to placebo
    Effects of ketamine infusion on neuropsychological functions under stress measured by WCST, SSRT, N-back and ToH
    Effects of ketamine infusion on hormonal stress response measured by salivary cortisol levels
    Effects of ketamine infusion on vegetative stress response measured by blood pressure and heart rate
    Effects of ketamine infusion on subjective stress levels after acute stress induction measured by a visual analogue scale.
    E.5.2.1Timepoint(s) of evaluation of this end point
    -YBOCS Score: baseline, one and seven days after each infusion

    -subjective obsessions: before, during, immediately after infusion and once every day post infusion for seven days

    -neurocognitive tests, subjective stress, hormonal and vegetative stress response: 3 time points, 1 baseline, 1 after each 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 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 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 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
    End of trial is defined as timepoint when the last participant underwent all infusion procedures and completed all symptom assessments including an end of study examination

    Trial will end earlier if patients safety is at risk
    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: 35
    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 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 state35
    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)
    Follow up treatment at the inpatient unit of the Department of Psychiatry and Psychotherapy will be possible if the intervention proves to be beneficial.
    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 Decision2022-03-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-04-25
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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