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    Summary
    EudraCT Number:2015-005338-23
    Sponsor's Protocol Code Number:MKAEWC1
    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:2016-07-11
    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 number2015-005338-23
    A.3Full title of the trial
    Targeting fear memory by disrupting the process of memory reconsolidation: A new intervention for panic disorder.
    Het verstoren van geheugenrecondolidatie als behandeling voor paniekstoornis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A new treatment for panic disorder
    Een nieuwe behandeling voor paniekstoornis
    A.4.1Sponsor's protocol code numberMKAEWC1
    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 of Amsterdam
    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 of Amsterdam
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity of Amsterdam
    B.5.2Functional name of contact pointClinical trial information
    B.5.3 Address:
    B.5.3.1Street AddressNieuwe Achtergracht 129
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1001 NK
    B.5.3.4CountryNetherlands
    B.5.6E-maila.a.p.vanemmerik@uva.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 Propranolol HCl
    D.2.1.1.2Name of the Marketing Authorisation holderTEVA Pharmachemie
    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 Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral 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 placeboCapsule
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Panic disorder
    Paniekstoornis
    E.1.1.1Medical condition in easily understood language
    Fear of sudden panic attacks
    Angst voor onverwachte paniekaanvallen
    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
    Our study will test whether a single intervention of fear memory reactivation (35% C02 inhalation) followed by the intake of a beta-aderenergic blocker (40 mg propranolol HCl) reduces panic disorder symptoms.
    In deze studie wordt getest of een eenmalige reactivatie van het angstgeheugen (35% C02 inhalatie) gevolgd door inname van een betablokker (40 mg propranolol HCl) symptomen van paniekstoornis vermindert.
    E.2.2Secondary objectives of the trial
    Not applicable
    Niet van toepassing
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Aged between 18 and 65 years
    - A primary diagnosis of panic disorder according to DSM-V
    - Written approval of an independent physician for participation
    - Tussen 18 en 65 jaar oud
    - Paniekstoornis als primaire diagnose volgens DSM-V
    - Geschreven toestemming voor deelname van een onafhankelijk arts
    E.4Principal exclusion criteria
    - Other relevant treatment for panic disorder at the time of study - e.g., CBT
    - Diagnosis of depression
    - Diagnosis of psychosis
    - Use of psychotropic medication
    - History of pulmonary diseases
    - Metabolic acidosis
    - History of cardiovascular diseases
    - Heart problems among first-degree relatives
    - HR<60
    - BP < 90-60 or BP > 170-100
    - History of black-outs or fainting
    - Diabetes
    - Liver or kidney diseases
    - Hyperactive production of thyroid hormones
    - Epilepsy
    - Any medication contra-indicative of the use of propranolol
    - Pregnancy
    - Andere behandeling voor paniekstoornis tijdens de studie (bijvoorbeeld cognitieve gedragstherapie)
    - Depressieve stoornis
    - Psychotische stoornis
    - Gebruik van psychotrope medicatie
    - Longaandoening
    - Zuurvergiftiging van het bloed (metabole acidose)
    - Verleden van hartklachten
    - Hartklachten bij eerstegraads familieleden
    - Hartslag lager dan 60
    - Bloeddruk lager dan 90-60 of hoger dan 170-100
    - Een verleden van blackouts of flauwvallen
    - Diabetes
    - Lever of nierfunctiestoornissen
    - Overmatige productie van het schildklierhormoon
    - Epilepsie
    - Medicatie contra-indicatief voor het gebruik van propranolol
    - Zwangerschap
    E.5 End points
    E.5.1Primary end point(s)
    Absence of panic disorder diagnosis according to DSM-V (clinical interview) and a significant reduction in panic disorder symptoms (questionnaire)
    Afwezigheid van een paniekstoornis volgens DSM-V (klinisch interview) en een significante afname in paniekstoornis symptomen (vragenlijst)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Three months post-treatment
    Drie maanden na behandeling
    E.5.2Secondary end point(s)
    1 Willingness to inhale 35% C02
    2 A significant reduction in negative cognitive appraisals of panic
    3 A significant reduction in agoraphobic avoidance
    4 A significant reduction in panic-related bodily symptoms
    5 A significant reduction in anxious thoughts related to panic attacks and agoraphobic avoidance
    6 Absence of panic disorder diagnosis according to DSM-V
    7 A significant reduction in panic disorder symptoms
    1 Bereidheid om 35% C02 te inhaleren
    2 Een significante daling in negatieve reflecties over paniek
    3 Een significante daling agorafobische vermijding
    4 Een significante daling in paniekgerelateerde, lichamelijke symptomen
    5 Een significante daling in angstige gedachten, gerelateerd aan paniekaanvallen en agorafobische vermijding
    6 Afwezigheid van een paniekstoornis volgens DSM-V
    7 Een significante afname in paniekstoornis symptomen
    E.5.2.1Timepoint(s) of evaluation of this end point
    1 Three months post-treatment
    2 One week, three months, six months and one year post-treatment
    3 One week, three months, six months and one year post-treatment
    4 One week, three months, six months and one year post-treatment
    5 One week, three months, six months and one year post-treatment
    6 Six months and one year post-treatment
    7 One week, six months and one year post-treatment
    1 Drie maanden na behandeling
    2 Eén week, drie maanden, zes maanden en één jaar na behandeling
    3 Eén week, drie maanden, zes maanden en één jaar na behandeling
    4 Eén week, drie maanden, zes maanden en één jaar na behandeling
    5 Eén week, drie maanden, zes maanden en één jaar na behandeling
    6 Zes maanden en één jaar na behandeling
    7 Eén week, zes maanden en één jaar na behandeling
    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) 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 Yes
    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
    At three months post-treatment participants can receive additional treatment. Therefore, the end of the trial is at three months after treatment of the last participant. For exploratory measures participants' complaints are also assessed at six months and one year post-treatment.
    Drie maanden na behandeling is het voor proefpersonen toegestaan om aanvullende therapie te volgen. Derhalve is het einde van de trial drie maanden na behandeling van de laatste proefpersoon. Voor exploratieve analyses worden de klachten van proefpersonen ook zes maanden en één jaar na behandeling gemeten.
    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 months6
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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)
    Participants in the control conditions will be offered the option of receiving the active treatment or being referred to another mental healthcare setting at 3-months post-treatment. Nonresponders of the active condition can also be referred to another mental healthcare setting at 3-months post-treatment.
    Deelnemers die aan één van de twee controlecondities zijn toegewezen, krijgen drie maanden na behandeling de mogelijkheid om de actieve behandeling te ondergaan of doorverwezen te worden naar een andere GGZ instelling. Deelnemers in de actieve conditie die niet profiteren van de behandeling worden ook de mogelijkheid geboden om doorverwezen te worden naar een andere GGZ instelling.
    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 Decision2016-09-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-06-17
    P. End of Trial
    P.End of Trial StatusOngoing
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