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    Summary
    EudraCT Number:2014-004094-17
    Sponsor's Protocol Code Number:40-41200-98-9269
    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:2015-09-09
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2014-004094-17
    A.3Full title of the trial
    Cannabidiol enhancement of exposure therapy in treatment refractory patients with phobias.
    Het effect van het toevoegen van cannabidiol bij exposure behandeling van patiënten met therapieresistente fobische angststoornissen.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Does adding cannabidiol (a component of cannabis) enhance the treatment of phobias where patients are confronted with their fears (exposure treatment).
    Wordt behandeling van fobische angststoornissen waarbij patiënten hun angst opzoeken (exposurebehandeling) effectiever als de cannabiscomponent cannabidiol wordt toegediend voorafgaand aan een sessie?
    A.3.2Name or abbreviated title of the trial where available
    Cannabidiol in the treatment of phobic anxiety disorders
    Cannabidiol toegevoegd aan de behandeling voor fobische angststoornissen
    A.4.1Sponsor's protocol code number40-41200-98-9269
    A.5.4Other Identifiers
    Name:NTRNumber:21801
    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 SponsorUniversiteit Utrecht
    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 supportZonMw
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUtrecht University
    B.5.2Functional name of contact pointDr. J.M.P. Baas
    B.5.3 Address:
    B.5.3.1Street AddressHeidelberglaan 2
    B.5.3.2Town/ cityUtrecht
    B.5.3.3Post code3584CS
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31302533018
    B.5.6E-mailj.m.p.baas@uu.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 No
    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 nameCannabidiol
    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
    Phobic anxiety disorders: either generalized social phobia or panic disorder with agoraphobia.
    Patiënten met of een gegeneraliseerde sociale fobie of een paniekstoornis met agorafobie.
    E.1.1.1Medical condition in easily understood language
    Patients who experience severe anxiety in many social situations (such as giving a presentation or going to a party), and patients who have panic attacks when in an open field or surrounded by people.
    Patiënten die erg angstig zijn in verschillende sociale situaties (bijv. presentaties of feestjes) en patiënten met paniekaanvallen als ze in een open veld of omringd door mensen zijn.
    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 18.1
    E.1.2Level HLT
    E.1.2Classification code 10068299
    E.1.2Term Fear symptoms and phobic disorders (incl social phobia)
    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
    To test the hypothesis that administration of cannabidiol as an augmentation step in combination with exposure therapy can strengthen treatment outcome in patients with phobic disorders (generalized social anxiety and panic disorder with agoraphobia) who do not respond satisfactorily to treatment as usual.
    Het testen van de hypothese dat het toevoegen van cannabidiol voorafgaand aan exposure behandeling de effectiviteit van de therapie vergroot bij patiënten met een gegeneraliseerde sociale fobie of paniekstoornis met agorafobie (die onvoldoende effect ondervonden van gebruikelijke zorg).
    E.2.2Secondary objectives of the trial
    Goal 2: To experimentally study the fear extinction enhancing properties of cannabidiol in patients. Does cannabidiol lead to faster fear extinction than placebo in phobic individuals, when tested in a controlled laboratory fear conditioning model?
    Goal 3: To profile patients depending on genetic/biological/personality characteristics in order to be able to use personalised treatments for individuals.
    Goal 4: Examine the cost effectiveness of cannabidiol as opposed to exposure therapy alone.
    Goal 5: Explore epigenetic differences
    Doel 2: Binnen een experimentele studie de eigenschappen van cannabidiol ten aanzien van het uitdoven van angst onderzoeken. Leidt cannabidiol er vergeleken met placebo bij patiënten met de hiervoor genoemde angststoornissen toe dat angst sneller uitdooft (als het onder gecontroleerde omstandigheden wordt getest in een laboratorium situatie door middel van een angst conditioneringsmodel).
    Doel 3: Profielen ontwikkelen van patiënten gebaseerd op genetische/biologische/persoonlijkheids-karakteristieken om zo persoonlijke behandelingen te kunnen gebruiken.
    Doel 4: De kosten effectiviteit van cannabidiol onderzoeken tegenover exposure behandeling apart.
    Doel 5: Epigenetische verschillen exploratief onderzoeken
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients will be invited to participate when they fulfill the DSM IV criteria for a diagnosis of either generalized social phobia or panic disorder with agoraphobia, and provided that they have not or only partially responded to treatment in the year preceding referral to the outpatient clinics. We will use the following definition of patients who only partially responded to treatment:
    a) having been treated in the past year for the same symptoms (psycho- or pharmacotherapy) and/or
    b) specifically referred to second-line treatment to Altrecht or GGZ inGeest
    Patiënten zullen worden uitgenodigd om deel te nemen als zij voldoen aan de DSM IV criteria voor een gegeneraliseerde sociale fobie of aan die voor een paniekstoornis met agorafobie, en met als voorwaarde dat zij onvoldoende baat hadden bij eerdere behandeling. In dit onderzoek zullen we gebruik maken van de volgende definitie voor patiënten die in het verleden niet (voldoende) reageerden op een behandeling:
    a) in het afgelopen jaar al ergens behandeld voor dezelfde klachten (psycho- of farmacotherapie) en/of
    b) specifiek doorverwezen voor tweedelijns behandeling naar Altrecht of GGZ inGeest
    E.4Principal exclusion criteria
    Patients with co-morbid severe psychiatric disorders (severe major depressive or bipolar disorder, psychosis, dependence of alcohol and drugs), with mental deficiency (IQ<80) or inability to adequately read or speak Dutch will be excluded, as well as persons with (a history of) epilepsy, cardiovascular disease or brain damage, renal or liver abnormalities, and a history of allergies on medication (adverse reactions or rash).
    Regular use of benzodiazepines and of antipsychotics will be an exclusion criterion, since benzodiazepine use might hamper the ERP effect. Use of SSRIs will be permitted, provided that dosages are kept constant during the study.
    Lastly pregnant or breastfeeding women will be excluded from the study.
    Patiënten met comorbide ernstige psychiatrische stoornissen (ernstige depressie of een bipolaire stoornis, psychose, afhankelijkheid van alcohol of drugs), met een verstandelijke beperking (IQ<80), patiënten die de Nederlandse taal onvoldoende machtig zijn, en patiënten epilepsie, hartproblemen of hersenschade in de voorgeschiedenis, nier- en leverabnormal komen niet aanmerking voor deelname. Dat geldt ook voor patiënten met nier- en leverproblemen, bepaalde allergieën, en patiënten met ernstige bijwerkingen door medicatie (bijv. huiduitslag). Veelvuldig gebruik van benzodiazepinen en/of het gebruik van antipsychotica, plus zwangerschap en het geven van borstvoeding zijn ook een exclusiecriterium.
    Gebruik van antidepressiva is wel toegestaan als de dosering constant blijft gedurende de studie.
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome measure will be the fear questionnaire (FQ) which measures presence and severity of all relevant phobic symptoms (Marks and Mathews 1979).
    De primaire uitkomstmaat zal zijn de fear questionniare die de aanwezigheid en ernst van alle relevante fobische symptomen meet (Marks & Mathews, 1979).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline, after every session, mid treatment, post treatment and at 3 and 6 months follow-up
    Voormeting, na elke van de 8 exposuresessies, bij de helft van de behandeling, na afloop van de behandeling en bij follow-up na 3 en 6 maanden
    E.5.2Secondary end point(s)
    Secondary outcome measures:

    1. General outcome measures:
    - Beck Anxiety Inventory (BAI; Beck and Steer 1990), on global anxiety severity;
    - Clinical Global Impression (CGI; Guy, 1976), on global functioning;
    - Beck Depression Inventory (BDI-2; Beck and Steer 1990), on depression severity;
    - Bodily Symptoms questionnaire Chambless et al. 1985);
    - Euro QOL 5D (Quality of Life; (EuroQol_group 1990), on global quality of life;
    - Tic-P (Hakkaart-van Roijen 2002), on loss of work and productivity due to disease.

    2. Disorder specific symptom measures:
    - In PD+AGO the Panic Disorder Severity Scale (PDSS; Shear et al. 1997), the Mobility Inventory and the Agoraphobic Cognitions Questionnaire (MI, ACQ) - Social phobia: the Social Phobia and Anxiety Inventory (SPAI; Bogels and Reith 1999; Bogels et al. 2010) and
    the Liebowitz Social Anxiety Scale (Mennin et al. 2002).

    Weekly measures during the sessions in the study period:
    - Subjective Unit of Distress Scale (SUDS; Wolpe 1969) is used to measure degree of in-session habituation/ and across session extinction, measured at the beginning and end of each session.
    - Quality of the ERP sessions
    Secundaire uitkomstmaten:

    1. Algemene uitkomstmaten:
    -De Beck Anxiety Inventory, een algemene maat voor de ernst van angstklachten.
    -De CGI (Clinical Global Impression), meet algemeen functioneren.
    -De Beck Depression Inventory (De BDI-2), meet de ernst van depressieve symptomen.
    -De Euro QOL 5D (EQ5D), meet kwaliteit van leven.
    -De Tic-P, bepaling van het functioneren op het werk en de productiviteit in het algemeen.

    2. Stoornis-gerelateerde uitkomstenmaten:
    - Bij PD+AGO de Panic Disorder Severity Scale (PDSS), Mobility Inventory en Agoraphobic Cognitions Questionnaire, voor het bepalen van de ernst van de panieksymptomen en de ernst van de agorafobie.
    - Bij Sociale fobie de Social Phobia and Anxiety Inventory (SPAI) en de Liebowitz Social Anxiety Scale, voor het bepalen van de ernst van sociaal fobische klachten.

    Wekelijkse metingen tijdens de behandeling:
    - De subjective Units of Distress Scale (SUDS), voor het meten van de mate van habituatie tijdens sessies en de mate waarin dit optreedt tussen de sessies in (wordt afgenomen bij het begin van elke sessie).
    - De kwaliteit van de exposuresessies
    E.5.2.1Timepoint(s) of evaluation of this end point
    taken at baseline, weekly after the 8 study ERP sessions, at mid treatment, at post-treatment and at 3 and 6 months follow up
    wordt bepaalde bij de voormeting, wekelijks na de 8 exposuresessies, bij de helft van de behandeling, na afloop van de behandeling en bij 3 en 6 maanden follow-up
    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 Yes
    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 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 trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    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
    Laatste bezoek van de laatste patient
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    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: 90
    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 No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation Information not present in EudraCT
    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 state90
    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)
    Treatment as usual
    Gebruikelijke zorg
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-11-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-09-08
    P. End of Trial
    P.End of Trial StatusOngoing
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