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    Summary
    EudraCT Number:2015-004153-40
    Sponsor's Protocol Code Number:PTF5
    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:2015-11-13
    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 number2015-004153-40
    A.3Full title of the trial
    TREATMENT OF SLEEP DISTURBANCES IN TRAUMA-AFFECTED REFUGEES – A RANDOMISED CONTROLLED TRIAL
    Behandling af søvnforstyrrelser hos traumatiserede flygtninge - et randomiseret studie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    TREATMENT OF SLEEP DISTURBANCES IN TRAUMA-AFFECTED REFUGEES – A RANDOMISED CONTROLLED TRIAL
    Behandling af søvnforstyrrelser hos traumatiserede flygtninge - et randomiseret studie
    A.3.2Name or abbreviated title of the trial where available
    PTF 5
    A.4.1Sponsor's protocol code numberPTF5
    A.5.4Other Identifiers
    Name:Ethics committeNumber:H-15014503
    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 SponsorCompetence Centre for Transcultural Psychiatry
    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 supportMental Health Services in the Capital Region of Denmark
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCompetence Centre for Transcultural Psychiatry
    B.5.2Functional name of contact pointHinuga Sandahl
    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 number4526847112
    B.5.6E-mailhinuga.sandahl.01@regionh.dk
    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 Mianserine
    D.2.1.1.2Name of the Marketing Authorisation holderOrifarm Generics A/S
    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.3.4Pharmaceutical form 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 INNmianserine hydrocloride
    D.3.9.3Other descriptive nameMIANSERIN HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB03283MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number10 to 30
    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
    Posttraumatic Stress Disorder (PTSD)
    E.1.1.1Medical condition in easily understood language
    Posttraumatic Stress Disorder (PTSD)
    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 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
    The overall aim of this study is to examine sleep enhancing treatment in refugees with PTSD in a randomised controlled trial.
    The objectives are:
    1. To estimate treatment effects of IRT and mianserin on sleep quality, sleep length and nightmares compared to treatment as usual (TAU) at CTP (Se description below)
    2. To study the relation between enhanced sleep, PTSD-symptoms, observer rated functioning and self-rated quality of life
    3. To examine predictors for positive outcome of treatment
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Adults (18 years or older)
    • Refugees or persons who have been family reunified with a refugee
    • PTSD pursuant to the ICD-10 research criteria
    • Psychological trauma experienced outside Denmark in the anamnesis. Trauma is imprisonment or detention with torture (according to the UN definition of torture) or acts of cruel, inhuman and degrading treatment or punishment. Trauma can also be organised violence, long-term political persecution and harassment, or war and civil war experiences.
    • Sleep disturbances/ PSQI >8
    • Nightmares/ HTQ score on nightmare item ≥ “a little”
    • Signed informed consent
    E.4Principal exclusion criteria
    • Severe psychotic disorder (defined as patients with an ICD-10 diagnosis F2x and F30.1-F30.9). Patients are excluded only if the psychotic-like experiences are assessed to be part of an independent psychotic disorder and not part of a severe PTSD and/or depression
    • Current abuse of drugs or alcohol (F1x.24-F1x.26)
    • Known neurodegenative disorder (Alzheimer’s disease AD, Parkinson’s disease PD, Levy-Body dementia LBD)
    • In need of admission to psychiatric hospital
    • Pregnant and breastfeeding women and women of the reproductive age who wish to conceive during the project period.
    • Allergy towards active ingredients or excipients in mianserin
    • Lack of informed consent
    E.5 End points
    E.5.1Primary end point(s)
    Total score on Pittsburgh Sleep Quality Index (PSQI)
    E.5.1.1Timepoint(s) of evaluation of this end point
    2018
    E.5.2Secondary end point(s)
    • Harvard Trauma Questionnaire (HTQ).
    • The Disturbing dreams and Nightmare Severity Index (DDNSI)
    • Hopkins Symptom Check List-25 (HSCL-25)
    • WHO-5
    • Global Assessment of functioning – Symptoms GAF-S and functioning GAF-F
    • Sheehan Disability Scale (SDS)
    • REM Sleep Behavior Disorder Screening Questionnaire (RBDSC)
    • Brief Pain Inventory short form (BPI)
    • The World Health Organization Disability Assessment Schedule (WHODAS 2.0)
    • Hamilton depression and anxiety scales (HAM A+D)
    • Actigraph measures
    E.5.2.1Timepoint(s) of evaluation of this end point
    2018
    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 No
    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) 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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Psychotherapy
    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
    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 months
    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: 215
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    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 state230
    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
    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 Decision2016-01-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-12-16
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-03-18
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