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    Summary
    EudraCT Number:2019-001692-37
    Sponsor's Protocol Code Number:ketamine_plus_CBASP
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-07-19
    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 ConcernedGermany - BfArM
    A.2EudraCT number2019-001692-37
    A.3Full title of the trial
    Pharmacologic treatment augmentation in chronic depression
    randomized, controlled, double blinded, phase II study
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Pharmacologic treatment augmentation in chronic depression
    randomized, controlled, double blinded, phase II study
    A.3.2Name or abbreviated title of the trial where available
    ketamine plus CBASP
    A.4.1Sponsor's protocol code numberketamine_plus_CBASP
    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 Hospital Tuebingen
    B.1.3.4CountryGermany
    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 Hospital Tuebingen
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationZentrum für klinische Studien
    B.5.2Functional name of contact pointManola Zago
    B.5.3 Address:
    B.5.3.1Street AddressFrondsbergstr. 23
    B.5.3.2Town/ cityTuebingen
    B.5.3.3Post code72076
    B.5.3.4CountryGermany
    B.5.4Telephone number0049707129 85629
    B.5.5Fax number0049707129 425080
    B.5.6E-mailzks-pm@med.unituebingen.de
    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 Inresa 2 ml
    D.2.1.1.2Name of the Marketing Authorisation holderInresa Arzneimittel GmbH, Freiburg
    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 Inresa 2 ml
    D.3.2Product code 26671.00.00
    D.3.4Pharmaceutical form Infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous 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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Fresenius Kabi Deutschland GmbH Isotone E NaCL 0.9
    D.2.1.1.2Name of the Marketing Authorisation holderFresenius Kabi Deutschland GmbH
    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 nameFresenius Kabi Deutschland GmbH Isotone E NaCL 0.9
    D.3.2Product code 6096595.00.00
    D.3.4Pharmaceutical form Infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous 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 placeboInfusion
    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
    Males and females between 18-64 years with a diagnosis of
    chronic depression
    E.1.1.1Medical condition in easily understood language
    Males and females between 18-64 years with a diagnosis of
    chronic depression
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Mental Disorders [F03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10066555
    E.1.2Term Chronic depression
    E.1.2System Organ Class 100000004873
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Reduction of depressive symptoms (assessed with
    Montgomery–Åsberg Depression Rating Scale
    (MADRS), Schmidtke et al., 1988) between start of
    and six weeks after end of combination treatment
    (Δ t1-t3) in group 1 (ketamine plus CBASP) vs.
    group 2 (placebo plus CBASP) and in group 1 vs.
    group 3 (ketamine plus TAU)
    E.2.2Secondary objectives of the trial
    • Depressive Symptoms (assessed with Montgomery–
    Åsberg Depression Rating Scale (MADRS), Schmidtke
    et al., 1988) between start of combination treatment
    and three months after the end of study treatment (Δ
    t1- follow up)
    • Reduction of self-reported depressive symptoms
    (assessed with Beck-Depression-Inventory (BDI), Beck
    et al., 2001) between start of and six weeks after end
    of combination treatment (Δ t1-t3) in group 1 (ketamine
    plus CBASP) vs. group 2 (placebo plus CBASP) and in
    group 1 vs. group 3 (ketamine plus treatment as usual)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Age 18-64 at the time of study inclusion
    • Diagnosis of chronic depression: recurrent depressive
    disorder, severe or moderate episodes (no full remission
    between the episodes according to DSM-IV-TR (Falkai et
    al., 2015) [no distinct depressive symptoms for at least two
    months]) or acute depressive episode lasting two or more
    years
    • Treatment resistance stage 2 according to Thase & Rush
    (1997): Patient’s symptoms fulfil the criteria of chronic
    depression listed above even after at least two appropriate
    treatment attempts with two antidepressant medicaments
    from two different effect categories
    • Patient’s symptoms fulfil the criteria of chronic depression
    listed above even after executing at least 12 sessions of
    psychotherapeutic treatment (psychoanalysis, depth
    psychology-based psychotherapy or cognitive behaviour
    therapy)
    • Ability to give approval; Ability to understand and
    voluntarily sign the informed consent form
    • Ability to adhere to the study visit schedule and other
    protocol requirements
    • Contraception:
    Male must agree to use a condom during any heterosexual
    contact with Females of Childbearing Potential (FCBP) from
    the first infusion until 65 days after the last infusion, even if he
    has undergone a successful vasectomy, as well as to not
    donate semen or sperm during this time period.
    FCBP must agree to use two reliable forms of contraception
    simultaneously or practice complete abstinence from
    heterosexual contact from study start until 28 days after the
    last infusion.
    E.4Principal exclusion criteria
    • Acute substance misuse as primary diagnosis
    • Neurologic disorders: Stroke, cerebral ischemia, tumor,
    cerebral infection, autoimmune disease
    • Disorders with increase of intracranial pressure, e.g. due
    to head injury
    • Circulatory disturbance in the brain
    • Pregnant or lactating females
    • Participation in any clinical study or having taken any
    investigational therapy, which would interfere with the
    study’s primary end point
    • Epilepsy
    • History of hypersensitivity to an investigational medicinal
    product or to any drug with similar chemical structure or to
    any excipient present in the pharmaceutical form of the
    investigational medicinal product
    • Pretreatment with ketamine hydrochloride and/ or CBASP
    • Not or insufficiently treated hypertonia (arterial hypertonia
    – systolic/ diastolic blood pressure higher than 150/ 100
    mmHg at rest)
    • Not or insufficiently treated hyperthyrodism
    • Heartache due to insufficient blood circulation (unstable
    angina pectoris) or heart muscle infarct (myocard infarct)
    during the last six months
    • Increased intraocular pressure (glaucoma) and perforating
    eye injury
    • Interventions in the area of the upper respiratory passages
    E.5 End points
    E.5.1Primary end point(s)
    The primary objective of the investigation is to test, whether the combination of ketamine
    hydrochloride (Ketamin Inresa 2 ml) and CBASP leads to a greater reduction in depressive
    symptoms between start of and six weeks after end of combination treatment (Δ t1-t3) in
    group 1 (ketamine plus CBASP) vs. group 2 (placebo plus CBASP) and in group 1 vs. group
    3 (ketamine plus TAU).
    Depressive symptoms will be assessed by the Montgomery Asberg Depression Rating Scale
    (MADRS, Schmidtke et al., 1988), a standardized and widely used clinician rating scale. The
    MADRS will bei conducted by a rater independent of the the treatment team and blind to
    treatment condition.
    E.5.1.1Timepoint(s) of evaluation of this end point
    For further detailled information, please refer to p.25 Chapter 3; Figure 1

    Week 7 to Week 12 (MADRS), t2 and t3
    E.5.2Secondary end point(s)
    Secondary outcome 1 tests if the effects last over a period of three months after the end of
    treatment. Secondary outcome 2 compares the reduction of self-reported depressive
    symptoms (assessed with Beck-Depression-Inventory (BDI), Beck et al., 2001) between start
    of and six weeks after end of combination treatment (Δ t1-t3) in group 1 (ketamine plus
    CBASP) vs. group 2 (placebo plus CBASP) and in group 1 vs. group 3 (ketamine plus TAU).
    E.5.2.1Timepoint(s) of evaluation of this end point
    For further detailled information, please refer to p.25 Chapter 3; Figure 1

    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 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 trial3
    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
    The End of Study for a patient enrolled in this trial is defined as follow up.
    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 months
    E.8.9.1In the Member State concerned days
    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: 60
    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 state60
    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)
    In case the offered treatment is effective and compatible, patients in outpatient treatment can
    take part in the CBASP group session for another 3 months. Apart from that, they can
    receive outpatient treatment as usual (psychotherapist, psychiatrist). In most cases, such
    treatment following an inpatient treatment is necessary. Therefore, during inpatient
    treatment, patients will be supported in organizing an outpatient psychotherapist and
    psychiatrist.
    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 Decision2019-08-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-02-24
    P. End of Trial
    P.End of Trial StatusOngoing
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