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    EudraCT Number:2011-004177-83
    Sponsor's Protocol Code Number:37202
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2011-09-07
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedNetherlands - Competent Authority
    A.2EudraCT number2011-004177-83
    A.3Full title of the trial
    Boosting the oxytocin system in acute trauma: The effectiveness of intranasal oxytocin treatments and stimulation of social support on preventing trauma related psychopathology
    Versterken van het oxytocine systeem in acuut trauma: de effectiviteit van oxytocine behandelingen en het stimuleren van sociale steun voor de preventie van traumagerelateerde psychopathologie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Oxytocine en social support after a traumatic event
    Oxytocine en sociale steun na een ingrijpende gebeurtenis
    A.3.2Name or abbreviated title of the trial where available
    Oxytocin and social support as early interventions in acute trauma
    Oxytocine en sociale steun als vroege interventies na acuut trauma
    A.4.1Sponsor's protocol code number37202
    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 SponsorAcademic Medical Center
    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 supportAcademic Medical Center, Research Counsil
    B.4.1Name of organisation providing supportZonMw
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAcademic Medical Center, Department of Psychiatry, Center for Anxiety Disorders
    B.5.2Functional name of contact pointOlff Oxytocine-Research Group
    B.5.3 Address:
    B.5.3.1Street AddressMeibergdreef 5
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1105 AZ
    B.5.4Telephone number+31(0)208913662
    B.5.5Fax number+31(0)208913664
    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. name Syntocinon, nasal spray 40 IU/ml
    D. of the Marketing Authorisation holderDefiante Farmacêutica, SA
    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 Nasal spray, solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntranasal use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 50-56-6
    D.3.9.3Other descriptive nameOXYTOCIN
    D.3.9.4EV Substance CodeSUB09580MIG
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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 placeboNasal spray, solution
    D.8.4Route of administration of the placeboIntranasal use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Posttraumatic Stress Disorder (PTSD) according to criteria in the DSM-IV
    Posttraumatische Stress Stoornis (PTSS) volgens de DSM-IV
    E.1.1.1Medical condition in easily understood language
    posttraumatic stress disorder
    posttraumatische stress stoornis
    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 14.0
    E.1.2Level PT
    E.1.2Classification code 10036316
    E.1.2Term Post-traumatic stress disorder
    E.1.2System Organ Class 10037175 - Psychiatric disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    In recently traumatized individuals (at the latest on day ten post trauma exposure) with a high initial level of distress, we aim to assess the effectiveness of intranasal OT and a semi-structured social support intervention in preventing symptoms of PTSD at one and three months post trauma follow-up.
    Het primaire studiedoel is om in recent getraumatiseerden met een hoog niveau van acute stress-klachten de effectiviteit van intranasale oxytocine (OT) behandelingen en een semi-gestructureerde sociale steun interventie op PTSS symptomen tijdens één en drie maanden na het trauma te onderzoeken.
    E.2.2Secondary objectives of the trial
    • Investigate the effects of oxytocine (OT) and social support intervention on depression and general anxiety symptoms, psychophysiological and neuroendocrine measures, perceived social support and psychological functioning after one week, and at one, three and six months post trauma follow-up;
    • Examine potential associations between the main study outcome and gender, genetic variation, subjective measures of social support, representations of attachment style, coping style, subjective health complaints, affect, quality of life, trauma type and history of (childhood) trauma and life events.
    - het onderzoeken van het effect van de OT en de sociale steun interventie op depressie en algemene angst symptomen, psychofysiologische / neuroendocriene maten, de ervaren sociale steun en psychologisch functioneren op één week na de eerste behandeling en op één, drie en zes maanden na traumablootstelling.
    - het onderzoeken van de potentiële associaties tussen de primaire studie-uitkomst en geslacht, genetische variatie, ervaren sociale steun, hechtingsstijl, coping stijl, subjectieve gezondheidsklachten, affect, kwaliteit van leven, trauma type en eerder trauma (in de kindertijd).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    ● Presentation at the Trauma Unit or Emergency Department after a potential traumatic event, according to PTSD A1 criterion in the DSM-IV
    ● Trauma Screening Questionnaire (TSQ) > 5 between 24 and 72 hours after trauma exposure
    ● Age 18 – 65 years
    ● Significant other (i.e. best friend, partner or family member) willing to join the social support intervention
    ● Capable to read and comprehend either the Dutch or English language
    ● Presentatie op de Trauma Unit of Spoedeisende Hulp na een potentiëel traumatische gebeurtenis volgens PTSD criterium A1 in de DSM-IV
    ● Trauma Screening Questionnaire (TSQ) > 5, tussen 24 en 72 uur na blootstelling aan trauma
    ● Leeftijd 18 – 65 jaar
    ● Significante ander (i.e. beste vriend(in), partner of familielid) die bereid is om deel te nemen aan de sociale steun interventie
    ● Schriftelijke toestemmingsverklaring
    ● Het voldoende beheersen van de Nederlandse taal om het te lezen en te begrijpen
    E.4Principal exclusion criteria
    ● Any severe or chronic systemic disease
    ● Current psychotic, bipolar, substance-related, severe personality disorder, or mental retardation
    ● Current severe depressive disorder
    ● Prominent current suicidal risk or homicidal ideation
    ● Severe cognitive impairment or a history of organic mental disorder
    ● Evidence of PTSD or depression immediately prior to the index trauma
    ● History of neurological disorders (e.g., traumatic brain injury, seizure history)
    ● Reports of ongoing traumatization (e.g., in case of partner violence as index adult trauma)
    ● Evidence of clinically significant and unstable medical conditions in which OT administration is contra-indicative such as cardiovascular, gastro-intestinal, pulmonary, severe renal, endocrine or hematological disorders, glaucoma, history of epilepsy, or a stroke or myocardial infarction within the past year
    ● Use of prostaglandins and certain anti-migraine medications (ergot alkaloids)
    ● Sensitivity or allergy for OT or its components (e.g., methylhydroxybenzoate and propylhydroxybenzoate)
    ● Impaired consciousness, or amnesia or confusion (due to for example head injury) (Glasgow Coma Scale lower than 13)
    ● Female participants: pregnancy and breast feeding (NB. Female participants with childbearing potential must have a negative pregnancy test).
    - Een ernstige of chronische systemische ziekte
    - huidige psychotische, bipolaire, middelengerelateerde, ernstige persoonlijkheidsstoornis, of mentale retardatie
    - huidige ernstige depressieve stoornis
    - Huidig suïcide risico of suïcidale ideatie
    - Ernstige cognitieve beperking of een organische mentale stoornis in de anamnese
    - Aanwijzingen voor PTSS of depressie vlak voor het index trauma
    - Neurologische stoornis in de anamnese (bv. traumatisch hersenletsel, convulsies)
    - Aanwijzingen voor continuerende traumatisatie (bv in het geval van partner geweld als index trauma)
    - Aanwijzingen voor klinisch significante,onstabiele medische toestand, waarbij een contraindicatie bestaat voor toediening van oxytocine, zoals cardiovasculaire, gastro-intestinale, pulmonaire, renale, endocriene of hematologische stoornissen, glaucoom, epilepsie in de anamnese, of een beroerte of myocardinfarct in het afgelopen jaar.
    - Het gebruik van prostaglandines en bepaalde anti-migraine medicatie (ergot alkaloides)
    - Overgevoeligheid/allergie voor oxytocine of de bestanddelen (bv methylhydroxybenzoaat en propylhydroxybenzoaat)
    - Aangetast bewustzijn, of amnesie of verwarring (ten gevolg van bijvoorbeeld hoofd letsel) (Glasgow Coma Scale < 13)
    - Vrouwelijke proefpersonen: zwangerschap, borstvoeding (NB. vrouwelijk proefpersonen in de vruchtbare leeftijd moeten een negatieve zwangerschapstest hebben)
    E.5 End points
    E.5.1Primary end point(s)
    The main study outcome is the difference in PTSD symptoms severity (CAPS scores) between the four trial arms (i.e. oxytocine (OT) + social support; placebo + social support; OT + no intervention additive to care as usual; placebo + no intervention additive to care as usual) at one and three months post trauma follow-up.
    De primaire studie-uitkomst is het verschil in ernst van PTSS symptomen (CAPS score) tijdens 1 en 3 maanden na trauma follow-up tussen de vier studie-armen (oxytocine (OT) + sociale steun; OT + geen toegevoegde sociale steun interventie; placebo + sociale steun; placebo + geen toegevoegde sociale steun interventie).
    E.5.1.1Timepoint(s) of evaluation of this end point
    1 and 3 months post trauma
    1 en 3 maanden na trauma
    E.5.2Secondary end point(s)
    • Difference between the four groups in depression and general anxiety symptoms, neuroendocrine and psychophysiological measures, perceived social support and psychological functioning after one week of OT treatments, and one, three and six months post trauma exposure.
    • Potential associations between the main study outcome and gender, genetic variation, subjective measures of social support, representations of attachment style, coping style, subjective health complaints, affect, quality of life, trauma type, history of (childhood) trauma and life events.
    - Verschillen tussen de vier groepen in depressieve en algemene klachten, psychofysiologische en neuroendocriene parameters, subjectieve sociale steun en psychologisch functioneren één week na de eerste behandeling en tijdens één, drie, en zes maanden na trauma follow-up.
    - Associaties tussen de primaire studie uitkomstmaten en geslacht, genetische variatie, subjectieve maten van sociale steun, hechtingsstijl, coping stijl, subjectieve gezondheidsklachten, affect, kwaliteit van leven, trauma type en verleden van trauma (in de kindertijd).
    E.5.2.1Timepoint(s) of evaluation of this end point
    7-10 days after trauma; 14-17 days after trauma; 1, 3, 6 months after trauma
    7-10 dagen na trauma; 14-17 dagen na trauma; 1, 3 en 6 maanden na trauma
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    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. 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 Yes
    E. description
    Psychosociale steun interventie
    Psychosocial support intervention
    E.8.2.4Number of treatment arms in the trial4
    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
    When all included participants finished all assessments or have dropped out
    Wanneer alle geincludeerde patienten alle metingen hebben afgerond of niet meer deelnemen aan de studie
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    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: 260
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2011-09-07. Yes
    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 Yes
    F. of other specific vulnerable populations
    Recently traumatized individuals
    Recent getraumatiseerde personen
    F.4 Planned number of subjects to be included
    F.4.1In the member state260
    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)
    care as usual, if necessary
    care as usual, indien nodig
    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 Decision2011-09-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-11-14
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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