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    Summary
    EudraCT Number:2013-004444-31
    Sponsor's Protocol Code Number:KWMP001
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2015-01-13
    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 ConcernedSweden - MPA
    A.2EudraCT number2013-004444-31
    A.3Full title of the trial
    Effects and consequences for mother and child from treatment for depression
    A prospective randomized, placebo- controlled, trial
    with internet-based cognitive behavior therapy and sertraline or placebo for moderate depression in pregnancy
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Treatment of maternal depression during pregnancy-efects for the mother and the child.
    A.3.2Name or abbreviated title of the trial where available
    Magdalena
    A.4.1Sponsor's protocol code numberKWMP001
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    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 No
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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 nameZoloft
    D.3.2Product code sertraline
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    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
    Prosepctive randomized two armed study to evaluate moderate depression during pregnancy treated with interbnetbased CBT and sertarline or placebo and longterm outcome in the children.Secondary objectives are effects on pregnancy, maternal bleeding, and epigenetic changes inthe mother and child.
    E.1.1.1Medical condition in easily understood language
    Moderate depression during pregnancy and treatment with internetbased CBT and sertraline or placebo and effects on longterm outcome in the children
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Longterm outcome in children exposed to maternal depression, treated with internetbased CBT and setraline or placebo, during fetal life.
    E.2.2Secondary objectives of the trial
    The secondary objectives are to evaluate the safety and the efficacy of sertraline in addition to treatment with ICBT. This include:
    a) to study if the effect of ICBT for pregnant women with moderate depression can be increased by adding sertraline
    b) to study if add-on treatment with sertraline increases the risk for maternal bleeding and pregnancy complications
    c) To study associations between antenatal maternal depression and endocrinological, inflammatory, epigenetic and telomere biology changes in relation to treatment effects of SSRI in mother and child
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Female > 18 years old
    2. Pregnant, gestational week 11-17 .
    3. Verified moderate depression according to SCID-I with or without concomitant anxiety disorder.
    4. Signed informed consent
    5. Able to understand the Swedish language orally and in written and able to use the internet for the ICBT
    6. Are willing to participate to all study visits
    7. Plans to give birth at the Department of Obstetrics at Karolinska University Hospital, Huddinge
    E.4Principal exclusion criteria
    Any of the below mentioned:
    1. Known drug or alcohol abuse
    2. Serious psychiatric disorder such as psychosis, bipolar disorder, severe personality disorder, ADHD/ADD, autism or mental retardation) and severe melancholic or psychotic depression.
    3. Known idiosyncrasy to Zoloft or allergy to one of the Zoloft excipients
    4. Ongoing medication with SSRI, SNRI, TCA, mood-stabilizers, antiepileptic drugs ,psychotropic drugs, tramadol, propafenon, tolbutamid, flekainid, psychostimulants and atomoxetine, insulin or steroids
    5. Any severe somatic disease that necessitate regular treatment with systemic steroids, severe heart and lung disease, kidney disease, liver disease, diabetes mellitus, or epilepsy with drug treatment.
    6. Women who either during screening or treatment on self-assessment forms (MADRS-S: 4 or more points on question about suicidal ideation (question 9)) report symptoms of severe suicidal thoughts or suicide plans will be contacted for structured suicide risk assessment by telephone (by experienced staff from the unit for internet psychiatry according to clinical routine). If judged necessary patients will be booked for psychiatric assessment by study nurse. If acute assessment or care is judged necessary, referral to psychiatric emergency departments will be made according to the same routine as in regular care.
    Also women, who contact the study personal and report symptoms of suicidal thoughts or suicide plans will receive psychiatric assessment as specified above. Women who according to psychiatric assessment have a high suicidal risk will be excluded from the study. These women will be actively transferred into necessary psychiatric treatment as usual.

    7. Other factors that are clinical significant and could jeopardize study results or its intention, as judged by study psychiatrist or study obstetrician.
     
    E.5 End points
    E.5.1Primary end point(s)
    Cognitive development at 2 years evaluated by the standard Bayley Scales of Infant and Toddler Development v 3 (BSID-III) in children exposed to maternal treatment with ICBT and sertraline compared to exposure to I-CBT only.
    E.5.1.1Timepoint(s) of evaluation of this end point
    2 yeras after birth of the child
    E.5.2Secondary end point(s)
    Maternal effects

    Add-on effect of sertraline measured in difference i) in self-report of depressive symptoms (MADRS-S),ii) in rate of remission from depression (measured by diagnostic psychiatric interview with MADRS at -12weeks, 14 weeks, and 30 weeks (= 3 months postpartum) of treatment.
    Treatment effect of ICBT calculated as change in self-report of symptoms (MADRS-S) from pre- and post- treatment and including the weekly measures between them.
    Treatment effect stability of ICBT calculated as change in MADRS-S from 12 to 22 weeks, including the measure at 14 weeks.
    Differenced in risk of suicidality between sertraline and placebo measured as change from baseline (measured by the suicidal ideation item in MADRS-S (item 9) and MADRS )
    Effects on levels of saliva- and plasma cortisol, allopregnanolone, estradiol, progesterone, oxytocin, prolactin, corticotrophin-releasing hormone (CRH), S-hCG, cytokines, EGF, VEGF, BDNF
    Epigenetic and telomere biology assessments: DNA methylation, telomere length and telomerase activity
    Pharmacological assessment: sertraline serum concentration, sertraline metabolism,
    Evaluate the risk for maternal postpartum bleeding in ml and postpartum hemoglobine day 2. APTT /TPK and placenta biopsy for evaluation of 11 beta-hydroxysteroid dehydrogenase type 2 and DNA methylation for telomere length and telomerase activity.
    Evaluate risk for pregnancy complications preeclampsia, placental abruption and increased cesarean section rate.



    Neonatal effects:
    Admission to neonatal care unit

    Plasma concentrations of sertraline, cortisol, 5-HTAA, S100, brain-derived neurotropic factor (BDNF), genetic variants of metabolizing enzymes/transporters, telomerase activity through the umbilical vein and buccal swabs for analysis of epigenetic variables and telomere biology.
    Infant motor behavior examined with standardized methods HINE) and neonatal abstinence effects scored with NAS
    E.5.2.1Timepoint(s) of evaluation of this end point
    After delivery of the child, and in the neonatal period
    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 Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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 Yes
    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 Yes
    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 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 the last child born of a woman included in the study reaches the age of 2 years
    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: 200
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 No
    F.3.3.3Pregnant women Yes
    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 state200
    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)
    None
    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 Decision2015-01-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-08-13
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2019-11-04
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