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    Summary
    EudraCT Number:2015-003042-47
    Sponsor's Protocol Code Number:InsulaTOP
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2016-02-26
    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 ConcernedFrance - ANSM
    A.2EudraCT number2015-003042-47
    A.3Full title of the trial
    Psycho-biological substrates of therapeutic benefit of thermal cure on Generalized Anxiety Disorders
    Substrats psychobiologiques du bénéfice thérapeutique du thermalisme sur les troubles anxieux généralisés
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Psycho-biological substrates of therapeutic benefit of thermal cure on Generalized Anxiety Disorders
    Substrats psychobiologiques du bénéfice thérapeutique du thermalisme sur les troubles anxieux généralisés
    A.3.2Name or abbreviated title of the trial where available
    Insula-TOP
    Insula-TOP
    A.4.1Sponsor's protocol code numberInsulaTOP
    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 SponsorCentre Hospitalier Henri Laborit
    B.1.3.4CountryFrance
    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 supportCentre Hospitalier Henri Laborit
    B.4.2CountryFrance
    B.4.1Name of organisation providing supportAssociation Francaise pour la Recherche Thermale
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCentre Hospitalier Henri Laborit
    B.5.2Functional name of contact pointNicolas Langbour
    B.5.3 Address:
    B.5.3.1Street Address370 avenue Jacques Coeur
    B.5.3.2Town/ cityPoitiers
    B.5.3.3Post code86021
    B.5.3.4CountryFrance
    B.5.4Telephone number00335 16 52 61 18
    B.5.5Fax number00335 49 44 58 31
    B.5.6E-mailnicolas.langbour@ch-poitiers.fr
    D. IMP Identification
    D.IMP: 1
    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 Deroxat®
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxoSmithKline
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 Buccal tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPBuccal 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Generalised Anxiety Disorders
    Les Troubles Anxieux Généralisés (TAG)
    E.1.1.1Medical condition in easily understood language
    Generalised Anxiety Disorders
    Les Troubles Anxieux Généralisés (TAG)
    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 LLT
    E.1.2Classification code 10018105
    E.1.2Term Generalized anxiety disorder
    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
    Main objective is to quantify the therapeutic benefit of a thermal cure on generalized anxiety disorders and to understand the psycho-biological substrates of this improvement.
    L’objectif principal de cette étude, sur le plan clinique, sera de quantifier précisément le bénéfice thérapeutique d’une cure thermale sur la symptomatologie anxieuse, et de comprendre les substrats psychobiologiques de cette amélioration.
    E.2.2Secondary objectives of the trial
    • A decrease of Insula activity at rest during the answers to aversives pictures and during the task of subjective measurement of heartbeat.
    • A decrease of sensibility to emotional interference by subliminal presentation of emotional words thanks to a lexical task and a color recogniton task associated to simultaneous measurement of pysiological indicator of emotional activity ( dermal resistance)
    • Une diminution de l’activité de l’insula sera mise en évidence au repos, lors de réponses à des images aversives, et lors de la tâche de mesure subjective de battements cardiaques.
    • Une diminution de la sensibilité à l’interférence émotionnelle implicite générée par la présentation subliminale de mots chargés émotionnellement, quantification de cette interférence grâce à une tâche lexicale et une tâche de reconnaissance de couleurs, et associée à des mesures simultanées d’un indicateur physiologique de l’activation émotionnelle, la résistance cutanée
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Diagnostic of TAG according to DSM IV
    • No treatment by antidepressant for at least 2 months
    • No treatment by anxiolytic/neuroleptic/bete blockers/antipsychotic for at least 3 weeks
    • Global score of HAMA is greater or equal to 20
    • Score of HAMA symptoms greater or equal to 8
    • Score of HAMD lower or equal to 7
    • Age: Participants will be males and females, 18-75 years of age included.
    • For women, no ongoing pregnancy/ negative pregnancy test
    • No wounds
    • Affiliation to a social security system (recipient or assignee)
    • Signed written inform consent form
    • Patients diagnostiqués TAG
    • les patients n'ayant pas débuté :
    - un traitement par anti-dépresseur depuis moins de 2 mois,
    - un traitement par anxiolytique ou neuroleptique ou beta-bloquant, ou antipsychotique depuis moins de 3 semaines.
    • un score à l’échelle HAM-A totale ≥ à 20,
    • un score à la sous-échelle HAM-A symptômes somatiques ≥ à 8,
    • un score à l’échelle HAM-D ≤ 7,
    • âgés de 18 à 75 ans inclus,
    • pour les femmes : un test de grossesse négatif à l’inclusion (Béta-HCG plasmatiques)
    sous contraceptif pour les femmes non stériles (ménopause, hystérectomie, ligature de trompes),
    • ne pas présenter de plaie,
    • avoir signé un formulaire de consentement éclairé,
    • être bénéficiaire ou affilié à un régime d’Assurance Maladie
    E.4Principal exclusion criteria
    • Treatment by antidepressant for at least 2 months or a treatment by anxiolytic, neuroleptic for at least 3 weeks
    • Psychotropic treatment (antidepressant, anxiolytic and neuroleptic) between the preinclusion and inclusion
    • Psychotherapy during the 3 months prior to the inclusion
    • Thermal cure during the 6 months prior to the inclusion
    • Treatment by paroxetine (Deroxat® ou Divarius®) for at least 1 month with dose equal or superior to 20 mg per day during the 12 months prior to the inclusion
    • Contraindication to paroxetine
    • Enhanced protection (minors, pregnancies women, nursing women, , people Deprived of liberty by administrative or judicial decision, ...)
    • Blood donation during the 3 months prior to the inclusion
    • Ayant débuté un traitement par anti-dépresseur depuis moins de 2 mois, ou un traitement par anxiolytique ou neuroleptique depuis moins de 3 semaines.
    • Ayant entamé une nouvelle séquence thérapeutique psychotrope (antidépresseur, anxiolytique ou neuroleptique) entre la pré-inclusion et l’inclusion par le médecin investigateur.
    • Ayant débuté une psychothérapie durant les 3 mois précédant l'entrée dans l'étude.
    • Ayant réalisé une cure thermale dans les 6 derniers mois, quelle que soit la spécialité.
    • Ayant déjà été traité par la Paroxétine (Deroxat® ou Divarius®) sur une durée d’au moins un mois, à une dose au moins égale à 20mg par jour, dans les 12 derniers mois.
    • Présentant une contre-indication à la cure thermale
    • Présentant une contre-indication à la Paroxétine : hypersensibilité à la Paroxétine, association à l'Iproniazide, au Nialamide et à la Sélégiline ; association aux IMAO, grossesse, allaitement.
    • Bénéficiant d’une protection renforcée, à savoir les mineurs, les femmes enceintes allaitantes et parturientes, les personnes privées de liberté par une décision judiciaire ou administrative, les majeurs sous tutelle, les personnes séjournant dans un établissement sanitaire ou social et les malades en situation d’urgence.
    • Ayant effectué un don de sang au cours des 3 mois précédents l’inclusion dans l’essai
    E.5 End points
    E.5.1Primary end point(s)
    Changes of HAM-A score between day 1 and day 24.
    This modification should be associated to a decrease of insula activation during aversive images task and a decrease of the relation between insula activation and somatosensorial insight measured by heartbeat perception task.
    L’évolution du score à l’échelle HAM-A entre J1 et J24. Cette évolution devra être associée à une diminution de l’excitation de l’insula produite par des stimuli aversifs, et une diminution de la relation entre cette excitation et l’insight somatosensoriel mesuré par la tâche de perception de battements cardiaques.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The evaluation of primary end point is performed between day 1 and day 24
    L'évaluation sera réalisée entre J1 et J24
    E.5.2Secondary end point(s)
    • Sensibility non conscientious to emotional interference in lexical task and in color identification task
    • Modulation of electrodermal response during presentation of predictive stimuli on aversive images and its links to the subjective view of emotional state (Day 24)
    • Modulation of electrodermal response during presentation of predictive stimuli on aversive images and insula activation (Day 24)
    • Lost of significant correlation (Day 24) between HAM-A score, introspective acuity and insula hyperactivation
    • Evolution (Day 1 and Day 24) of the correlation between HAM-A global score and 1- the measure of heartbeat 2- emotional reactivity during aversive images task.
    • Difference (Day 1 and Day 24) of correlations between the symptoms severity and the activation of insula cortex during 1-aversive images task, 2-heartbeat measure task.
    • Evaluation of efficacy of the thermal cure Day 56 using HAM-A score

    • La sensibilité à l’interférence émotionnelle non consciente dans les tâches de décision lexicale et d’identification de couleur.
    • ,La réaction électrodermale à la présentation de stimuli prédictifs d’images aversives et sa relation au rapport subjectif de l’état affectif.
    • Le découplage entre la réaction électrodermale à la présentation de stimuli prédictifs d’images aversives et l’activation de l’insula à J24.
    • La disparition de la corrélation significative, à J24, entre le score HAM-A et l’acuité intéroceptive / l’hyperactivité de l’insula
    • Evolution (entre J1 et J24) de la corrélation entre le score global de l’échelle HAM-A et la mesure des battements cardiaques et de la réactivité émotionnelle à l’anticipation d’images à valence aversive.
    • Sur le plan neurobiologique, le critère de jugement sera la différence entre J1 et J24 des corrélations entre la sévérité de la symptomatologie et d’une part l’activation du cortex insulaire en situation d’anticipation d’images à valence aversive, d’autre part le test de mesure de battements cardiaques.
    • Evaluer l’efficacité de la cure à long terme (J56) par l’évolution de l’HAM-A.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1- D1/D24/D56
    2-D24
    3-D24
    4-D24
    5-D1/D24.
    6-D1/D24.
    7-D56
    1- J1/J24/J56
    2-J24
    3-J24
    4-J24
    5-J1/J24.
    6-J1/J24.
    7-J56
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Cure thermale
    Thermal cure
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months36
    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: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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)
    No difference with normal treatment
    Pas de différence avec la prise en charge habituelle
    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 Decision2015-12-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-11-18
    P. End of Trial
    P.End of Trial StatusOngoing
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