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    Summary
    EudraCT Number:2020-004487-25
    Sponsor's Protocol Code Number:KETASELF-1
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-09-29
    Trial results View 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 ConcernedSweden - MPA
    A.2EudraCT number2020-004487-25
    A.3Full title of the trial
    Experiencing the self through touch - self-other-distinction in an altered state of self: An exploratory randomized placebo-controlled experimental medicine study
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Experiencing the self through touch - self-other-distinction in an altered state of self: An exploratory randomized placebo-controlled experimental medicine study
    A.4.1Sponsor's protocol code numberKETASELF-1
    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 SponsorLinköpings Universitet
    B.1.3.4CountrySweden
    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 supportSwedish Research Council
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLinköpings Universitet
    B.5.2Functional name of contact pointMarkus Heilig
    B.5.3 Address:
    B.5.3.1Street AddressCentre for social and affective neuroscience
    B.5.3.2Town/ cityLinköping
    B.5.3.3Post code58183
    B.5.3.4CountrySweden
    B.5.4Telephone number00461036479
    B.5.6E-mailMarkus.Heilig@liu.se
    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 Ketamine
    D.2.1.1.2Name of the Marketing Authorisation holderAbcur
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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 Concentrate for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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 number10
    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 placeboConcentrate for solution for injection
    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
    Healthy volunteer.
    E.1.1.1Medical condition in easily understood language
    Healthy volunteer.
    E.1.1.2Therapeutic area Not possible to specify
    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
    1. Psychophysical measure: Tactile detection threshold during self-touch will be lower during the ketamine- than during the placebo-session.
    2. Neurophysiological measure: The difference between neural signatures of self-touch and other-touch will be smaller during the ketamine session than during the placebo-session.
    E.2.2Secondary objectives of the trial
    The psychophysical and neural touch-related effects of ketamine will be related to the strength of an altered self-experience during the ketamine session.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age 18-65 years, and willing to provide informed consent.
    2. Good health as determined by medical history, ECG, and clinical assessment of lab tests. Lab tests will include potassium, creatinine, hemoglobin, glucose, calcium, BUN, complete blood count, total bilirubin, TSH, AST, ALT, and GGT. The final decision will be according to the judgment of the lead physician.
    3. Proficiency in Swedish.
    4. Fertile females must have a negative urine pregnancy test (hCG) at inclusion and at the start of each study session. Females of childbearing potential who are sexually active and have not been surgically sterilized must agree to use an adequate method of birth control during the study.
    5. Participant must be willing to receive two i.v. lines and undergo an MRI scan.
    6. Participant must be willing to perform the touch task including self-touch and receiving touch from the investigator on the arm.
    E.4Principal exclusion criteria
    1. Any clinically significant medical condition, including CNS, cardiovascular, respiratory, gastrointestinal, hepatic, renal, endocrine, or reproductive disorders, as assessed by the Principal Investigator (PI) or designee, after appropriate consults if needed.
    2. Known hypersensitivity to ketamine, eclampsia, pre-eclampsia, increased intraocular pressure, hyperthyroidism, hydrocephalus, hypertension.
    3. Any current clinically significant psychiatric problems including a diagnosis of substance dependence other than nicotine (defined in DSM-5 terms as Substance Use Disorder, Moderate or Severe as assessed by PI or designee. Patients will be screened using the Modified Mini Screen (MMS), the Drug Use Disorder Identification Test (DUDIT), a urine drug screening, and the Alcohol Use Disorder Identification Test (AUDIT). The results and their clinical significance will ultimately be evaluated by a trained healthcare professional (psychiatrically trained nurse or physician). If indication is obtained that a clinically significant psychiatric disorder may be present, a full MINI interview will be carried out by appropriately trained staff.
    4. Any medical condition that, in the judgment of the PI or designee and after appropriate consultation if needed, is likely to influence cerebral blood flow or gross-level brain activity/anatomy, such as for instance: type-1 diabetes, cardiovascular or respiratory disease, history of significant head injury, hyper-/hypothyroidism, epilepsy.
    5. History of psychotic experiences and familial history (first and second degree relatives) of psychosis or alcohol use disorder.
    6. Any use of CNS-active medications, use of prescription or over-the-counter drugs that could interfere with the ketamine administration. This includes Theophylline, Suxametonium, Atracurium, Diazepam, Vasopressin, barbiturates, Ergometrine, sympathomimetics, narcotics and sedatives, inhalation anesthetics, muscular relaxants, thyroid hormones, antihypertensive agents, CYP3A4 inhibitors ((e g itraconazole, fluconazole, clarithromycin, erythromycin, verapamil, diltiazem) and CYP3A4 inducers (e.g. phenytoin, carbamazepine, St John´s Wort).
    7. Unable to provide a negative urine drug screen (including amphetamine, THC, opiates and benzodiazepines).
    8. Pregnancy, intention to become pregnant, or breastfeeding.
    9. Contraindications for magnetic resonance imaging (MRI) scanning, including ferromagnetic objects in the body that are contraindicated for MRI, and claustrophobia.
    10. Any other condition due to which, in the judgment of the PI or designee, participation in the study is not in the subject’s best interest, or is unlikely to yield valid data.

    E.5 End points
    E.5.1Primary end point(s)
    1. Tactile detection thresholds are quantified as the thinnest von Frey filament (in mN) the participant perceives reliably (min. 5 out of 10 trials) for each of the conditions (baseline, self-touch, other-touch, object-touch).

    2. Neural signatures of the different touch conditions are quantified as blood oxygen level dependent (BOLD) signal, a proxy measure for brain activity. Brain activity during the conditions self-touch and other-touch, and the difference between these conditions in terms of location and strength as evaluated with common statistical methods for functional brain imaging analysis is the outcome measure of interest.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1, Tactile treshold will be measured after each fMRI scan at visit 3 and visit 4.
    2, fMRI continously during 40 minutes at visit 3 and visit 4.
    E.5.2Secondary end point(s)
    The outcome measures described under primary endpoints will be correlated with self-report scales (STQ, AQ, MAIA) and clinical evaluation (CADSS).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Visit 2 and after MRI at visit 3 and 4.
    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
    Physiological
    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 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 trial2
    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
    LVLS
    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 Yes
    F.3.2Patients No
    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 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)
    None since it is healthy volunteers.
    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 Decision2020-11-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-02-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-11-25
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