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    Summary
    EudraCT Number:2011-006228-19
    Sponsor's Protocol Code Number:PTF3
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-03-20
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2011-006228-19
    A.3Full title of the trial
    The treatment of traumatized refugees with Setraline versus Venlafaxine - a randomized trial.
    Behandling af traumatiserede flygtninge med Sertralin versus Venlafaxin – et randomiseret studie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The treatment of traumatized refugees with Setraline versus Venlafaxine (two types of antidepressants) - a randomized trial.
    Behandling af traumatiserede flygtninge med Sertralin versus Venlafaxin (to typer antidepressiv medicin) – et randomiseret studie
    A.4.1Sponsor's protocol code numberPTF3
    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 SponsorPsykiatrisk Center Ballerup
    B.1.3.4CountryDenmark
    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 supportPsykiatrisk Traumeklinik for Flygtninge
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportSyddansk Universitet
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportTryg Fonden
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportRegion Hovedstadens Forskningsfond
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCompetencecenter for Transcultural Psychiatry
    B.5.2Functional name of contact pointCTP
    B.5.3 Address:
    B.5.3.1Street AddressMaglevænget 2
    B.5.3.2Town/ cityBallerup
    B.5.3.3Post code2750
    B.5.3.4CountryDenmark
    B.5.4Telephone number004538645178
    B.5.6E-mailcharlotte.sonne@regionh.dk
    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 Sertralin
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 nameSertralin
    D.3.4Pharmaceutical form Coated tablet
    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 INNSERTRALINE
    D.3.9.1CAS number 79617-96-2
    D.3.9.4EV Substance CodeSUB10499MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number200
    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.IMP: 2
    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 Venlafaxin
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 nameVenlafaxin
    D.3.4Pharmaceutical form Capsule, hard
    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 INNVenlafaxin
    D.3.9.1CAS number 99300-78-4
    D.3.9.3Other descriptive nameVENLAFAXINE HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB05087MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number375
    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
    Post traumatic stress disorder (PTSD)
    Depression
    Posttraumatisk belastningsreaktion (PTSD)
    Depression
    E.1.1.1Medical condition in easily understood language
    Post traumatic stress disorder
    Depression
    Posttraumatisk belastningsreaktion
    Depression
    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 17.0
    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
    To investigate whether or not there is a difference in the treament effect of Venlafaxine and Sertraline on PTSD symptoms in traumatized refugees.
    At undersøge om der er forskel på behandlingseffekten af Venlafaxin og Sertralin på PTSD symptomer hos traumatiserede flygtninge
    E.2.2Secondary objectives of the trial
    To investigate if changes in self-reported social functioning has any correlation to changes in depression and PTSD symptoms rated on Hamiltons Depression and Anxiety scales, Hopkins Symptom Checklist (HSCL-25) and Harvard Trauma Questionnaire (HTQ).

    To investigate to which extend doctors and psychologist initial estimation of expected benefit from treament correlates to the actual treament outcome.
    At undersøge om ændringer i selvrapporteret social funktion har sammenhæng med observatør vurderet forbedring af symptomscore på Hamiltons depressions- og angst-skala (HAM D+A) og med selv-rapporteret forbedring på Hopkins Symptom Checklist (HSCL-25) og Harvard Trauma Questionnaire (HTQ).

    At undersøge om indledende læge og psykologvurdering af forventet behandlingsudbytte (stort forventet udbytte, noget forventet udbytte og begrænset forventet udbytte) har sammenhæng med behandlingsudbyttet hos deltagerne i det randomiserede forsøg

    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients referred to Psychiatric traumaunit for refugees (PTF) between april 2012 and maj 2013
    - Grown ups (18 years old or above)
    - Symptoms of PTSD in accordance with the ICD-10 research criterias.
    - Psychological traume in their past
    - By doctor estimated to be motivated towards treatment
    - Informed consent given
    - Patienter henvist til behandling ved PTF fra april 2012 - maj 2013
    - Voksne (18 år eller ældre)
    - Flygtninge eller familiesammenførte med flygtninge
    - Symptomer på PTSD i henhold til ICD-10 diagnosekriterierne.
    - Psykisk traume i anamnesen.
    - Af læge vurderet motiveret for behandling
    - Informeret samtykke.

    E.4Principal exclusion criteria
    - Suffering from serious psychotic disorder (Defined as patients with a ICD-10 diagnose F2x and F30.1-F30.9)
    - Current abuse of drugs or alcohol (F.1x.24-F1x.26)
    - In need of admission to psychiatric facility
    - Informed consent no given
    - Pregnant or breat feeding
    - Svær psykotisk lidelse (defineret som patienter med ICD-10 diagnose F2x og F30.1-F30.9)
    - Aktivt misbrugende (F1x.24-F1x.26).
    - Indlæggelseskrævende
    - Manglende informeret samtykke.
    - Gravide og ammende.

    E.5 End points
    E.5.1Primary end point(s)
    To evaluate whether or not there is a difference in the treament effect of Venlafaxine and Sertraline on PTSD symptoms in traumatized refugees. Symptoms changes are evaluated on primarily on Havard Traume Questionnaire (HTQ) in both groups. The trial aims to include a number of 150 patients (75 in each group) as mentioned above.
    At undersøge om der er forskel på behandlingseffekten af Venlafaxin og Sertralin på PTSD symptomer hos traumatiserede flygtninge. Primært effektmål for symptomændringer i begge grupper er Havard Traume Questionnaire (HTQ). Studiet sigter mod at inkludere 150 deltagere (75 i hver gruppe) som tidligere nævnt.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Summer 2014
    Sommer 2014
    E.5.2Secondary end point(s)
    To evaluate whether changes in self-reported social functioning has any correlation to changes in depression and PTSD symptoms rated on Hamiltons Depression and Anxiety scales, Hopkins Symptom Checklist (HSCL-25) and Harvard Trauma Questionnaire (HTQ) in the participants included.

    To evaluate to which extend doctors and psychologist initial estimation of expected benefit from treament actually correlates to the treament outcome for the patients included.
    At evaluere på om ændringer i selvrapporteret social funktion har sammenhæng med observatør vurderet forbedring af symptomscore på Hamiltons depressions- og angst-skala (HAM D+A) og med selv-rapporteret forbedring på Hopkins Symptom Checklist (HSCL-25) og Harvard Trauma Questionnaire (HTQ) hos de inkluderede patienter.

    At evaluere på hvorvidt indledende læge og psykologvurdering af forventet behandlingsudbytte (stort forventet udbytte, noget forventet udbytte og begrænset forventet udbytte) har vist sammenhæng med behandlingsudbyttet hos deltagerne i det randomiserede forsøg.

    E.5.2.1Timepoint(s) of evaluation of this end point
    Summer 2014
    Sommer 2014
    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 Yes
    E.8.1.7.1Other trial design description
    Blindet Hamilton Depressions + angst rating
    Blinded Hamilton Depression and anxiety ratings
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    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 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 Yes
    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
    Last included patients finished with treatment
    Sidste inkluderede patient har afsluttet behandling
    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 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: 125
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 25
    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 2012-03-20. 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 No
    F.4 Planned number of subjects to be included
    F.4.1In the member state150
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 150
    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 for psychiatric patients - either by family doctor, district psychiatry center og private pschiatrist depending on the patients need.
    Adskiller sig ikke fra almindelig behandling af andre psykiatriske patienter - opfølgning enten via praktiserende læge, distriktspsykiatisk center eller privat praktiserende psykiater alt efter patientens behov.
    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 Decision2012-03-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-03-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-10-01
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