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    Summary
    EudraCT Number:2012-003191-39
    Sponsor's Protocol Code Number:
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2012-12-03
    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 ConcernedUK - MHRA
    A.2EudraCT number2012-003191-39
    A.3Full title of the trial
    The effect of a single-dose of d-cycloserine on the basic effects of cognitive-behaviour therapy for panic disorder - a randomized placebo-controlled trial
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The effects of combination treatment for panic
    A.3.2Name or abbreviated title of the trial where available
    The effects of d-cycloserine on learning
    A.4.1Sponsor's protocol code number
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01680107
    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 Oxford
    B.1.3.4CountryUnited Kingdom
    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 Research Council MRC
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity of Oxford
    B.5.2Functional name of contact pointDr Andrea Reinecke
    B.5.3 Address:
    B.5.3.1Street AddressDepartment of Psychiatry, University of Oxford, Warneford Hospital
    B.5.3.2Town/ cityOxford
    B.5.3.3Post codeOX37JX
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number0186226471
    B.5.6E-mailandrea.reinecke@psych.ox.ac.uk
    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 Cycloserine
    D.2.1.1.2Name of the Marketing Authorisation holderKing Pharmaceuticals Ltd
    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 nameCycloserine
    D.3.2Product code N/A
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNcycloserine
    D.3.9.1CAS number 68-41-7
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.2Concentration typeequal
    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
    DSM-IV Panic disorder
    E.1.1.1Medical condition in easily understood language
    Participants will be diagnosed with panic disorder, a severe form of anxiety that is characterised by the ocurrence of intense panic attacks, without an apparent external reason.
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Psychological processes [F02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level HLT
    E.1.2Classification code 10068300
    E.1.2Term Panic attacks and disorders
    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
    Does the combination of a single-session of cognitive-behaviour therapy (CBT) with the cognitive enhancer d-cycloserine (compared to placebo) lead to greater reduction in threat bias (computerised behavioural reaction tasks) on the day after treatment?
    E.2.2Secondary objectives of the trial
    Is such an increased change in threat bias underpinned by stronger alterations in responsivity in the fear circuit of the brain (fMRI) on the day after treatment?
    Does CBT plus d-cycloserine (versus placebo) lead to greater symptom improvement on the day after treatment and at follow-ups?
    Does CBT plus d-cycloserine (versus placebo) lead to greater stress resistance on the day after treatment and at follow-ups (stress test + VAS)?
    Are threat bias and/or brain responsivity on the day after treatment predictive of symptom changes during 1-month and 6-month follow-up?
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Diagnosed with DSM-IV panic disorder
    • At least moderate avoidance of agoraphobic situations (”yes” response to at least 3 situations listed under “(2) Avoidance – Do you avoid or feel very uncomfortable in …” in the Structured Panic Assessment Interview (Clark, 1989))
    • Participant is willing and able to give informed consent for participation in the study and to comply with all study requirements.
    • Male or Female, aged 18 years or above.
    E.4Principal exclusion criteria
    • Female participant who is pregnant, breast-feeding, or planning pregnancy
    • CNS-active medication during the last 6 weeks
    • Exposure-based psychological treatment for panic disorder and agoraphobia during the last 3 months
    • Lifetime history of psychosis, bipolar disorder, alcohol, medication or drug abuse or dependence; current primary depressive disorder
    • Lifetime history of epilepsy or other significant disease or disorder which, in the opinion of the investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant’s ability to participate in the study.
    • Insufficient English skills
    • Patient not able to refrain from benzodiazepines 48hrs before treatment and testing sessions
    • Any other significant disease or disorder or circumstance, which, in the opinion of the investigator, may either put the participant at risk or may influence the results of the study or the participant’s ability to participate in the study.

    Participants with contraindication to MRI scanning (e.g. pacemaker, metal implant, left-handedness) will be included in the study but will not undergo the MRI scan study component.
    E.5 End points
    E.5.1Primary end point(s)
    Threat bias reaction time scores derived from computerised behavioural reaction tasks
    E.5.1.1Timepoint(s) of evaluation of this end point
    This end point will be assessed at baseline (Visit 2) and on the day after treatment (Visit 3).
    E.5.2Secondary end point(s)
    a) responsivity in the fear circuit of the brain
    b) self-report symptom severity (Beck Depression Inventory, State and Trait form of the State-Trait Anxiety Inventory, Agoraphobic Cognitions Questionnaire, Body Sensations Questionnaire, Mobility Inventory, Panic Attack Scale)
    c) clinician-rated symptom severity (Panic Disorder Severity Scale - Clinician)
    d) anxiety ratings during a stress test (VAS)
    E.5.2.1Timepoint(s) of evaluation of this end point
    a) functional and structural MRI will be measured on the day after treatment (Testing Visit/ Visit 3)
    b) self-report symptom severity will be assessed at baseline (Visit 2), on the day after treatment (Visit 3), and at follow-up (Visits 4 and 5)
    c) clinician-rated symptom severity will be assessed at baseline (Visit 2) and at follow-up (Visits 4 and 5)
    d) stress test ratings will be assessed at baseline (Visit 2), on the day after treatment (Visit 3), and at follow-up (Visits 4 and 5)
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 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.8.4.1Number of sites anticipated in Member State concerned1
    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 years1
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days30
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months11
    E.8.9.2In all countries concerned by the trial days30
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 46
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 4
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 0
    F.4.2.2In the whole clinical trial 0
    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)
    This research aims to test the clinical effect of a single session of cognitive-behaviour therapy in combination with the drug d-cycloserine. Therefore, this intervention will not be provided beyond the planned experimental manipulations. However, all participants will be given information regarding treatment options and will be encouraged to contact their GP if they wish to continue treatment.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation N/A
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-01-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-01-21
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2017-09-27
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