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    The EU Clinical Trials Register currently displays   43602   clinical trials with a EudraCT protocol, of which   7206   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    EudraCT Number:2020-001592-33
    Sponsor's Protocol Code Number:0204
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-06-10
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedDenmark - DHMA
    A.2EudraCT number2020-001592-33
    A.3Full title of the trial
    Maternal Mental Health (MAMA) Study. Short time estrogen as a candidate strategy to prevent postpartum depression in a high-risk group
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Maternal Mental Health (MAMA) Study. Short time treatment with female sex hormone to prevent postpartum depression in a high-risk group
    A.3.2Name or abbreviated title of the trial where available
    MAMA Study
    A.4.1Sponsor's protocol code number0204
    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 SponsorRigshospitalet
    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 supportDesiree Ydes Fond
    B.4.1Name of organisation providing supportIndependent Research Fund Denmark
    B.4.1Name of organisation providing supportRigshospitalets forskningspulje
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRigshospitalet
    B.5.2Functional name of contact pointNeurobiology Research Unit
    B.5.3 Address:
    B.5.3.1Street AddressBlegdamsvej 9
    B.5.3.2Town/ cityCopenhagen
    B.5.3.3Post code2100
    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. name Vivelle Dot
    D. of the Marketing Authorisation holderNovartis Healthcare 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
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPTransdermal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEstradiol
    D.3.9.3Other descriptive nameESTRADIOL
    D.3.9.4EV Substance CodeSUB07242MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    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. 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 placeboTransdermal patch
    D.8.4Route of administration of the placeboTransdermal use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Perinatal depression with postpartum onset
    E.1.1.1Medical condition in easily understood language
    Depressive episode in relation to childbirth
    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 20.0
    E.1.2Level LLT
    E.1.2Classification code 10056393
    E.1.2Term Postpartum depression
    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
    To evaluate if short-term estradiol administration relative to placebo in the immediate postpartum period (day 0 to day 21) prevents depressive episodes in women with a history of postpartum depression
    E.2.2Secondary objectives of the trial
    1) To evaluate if short-term estradiol administration in the immediate postpartum affects the early mother-infant interaction and the proportion of women who exclusively breastfeed their infants.
    2) To determine if candidate biomarkers (gene transcription and DNA methylation based) of estrogen sensitivity identify women who benefit from the short-term estradiol regimen.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Title: Precision medicine in perinatal depression: perceptions and expectations to individual biological causes of depression.

    Objective: Through qualitative interviews to gain unique information women’s perceptions of biologically informed preventive precision medicine in relation to perinatal depression.
    E.3Principal inclusion criteria
    • Women between 18 and 45 years and pregnant in the third trimester.
    • Previously perinatal depression with the onset of depressive episode in pregnancy or within 6 months of birth or untreated depressive episode assessed by retrospective interview by healthcare professional.
    E.4Principal exclusion criteria
    • Antidepressant treatment by inclusion in the study.
    • Moderate to severe depression developed in pregnancy before day 0 postpartum.
    • Severe mental illness, e.g. diseases of the schizophrenic spectrum, psychotic conditions, inpatient active eating disorder or hospitalising OCD, and bipolar affective disorder.
    • Previous suicide attempts outside the depressive episode.
    • Present or previous neurological disease including migraines and epilepsy.
    • Severe medical disease.
    • Past or ongoing cancer.
    • Previous venous thromboembolism, myocardial infarction, cerebrovascular thromboembolism or known thrombophilic diseases and risk factors clinically assessed after thrombophilic screening.
    • Deep vein thrombosis or pulmonary embolism in current pregnancy.
    • Pregnancy-related hypertension or preeclampsia.
    • Manifest atherosclerosis or known cardiovascular risk factors (including diabetes, hypertension).
    • Other contraindication for estrogen treatment (e.g. acute liver disease, varicicated varicencies).
    • Use of psychotropic pharmacology, except for short-term sleep support treatment, which is likely to influence the results of the study.
    • Non-fluent in Danish or pronounced vision or hearing loss.
    • Current or previous learning difficulties.
    • BMI >35 kg/m2.
    • Current alcohol or drug abuse.
    • Multiple pregnancy.
    • Severe postpartum haemorrhage (>1500 ml).
    • Serious illness or neonatal death in the child.
    E.5 End points
    E.5.1Primary end point(s)
    Clinical depression according to DSM-V criteria.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Between 2 weeks and 6 months postpartum
    E.5.2Secondary end point(s)
    1) Proportion of women who have depression symptoms as measured by the Edinburgh Postnatal Depression Scale (EPDS) with cut-off ≥11 in the active and placebo groups respectively.
    2) Subclinical depression defined by a difference of 5 points or more relative to baseline on the Hamilton Depression Rating Scale, 6 items (HAMD-6).
    3) Mother's mental well-being defined as difference of 10 points or more relative to baseline on who-5 Well-Being Index by (WHO-5).
    4) Proportion of women who exclusively nourish their child by breastfeeding (interview informed).
    5) Symptoms of parental stress rated by scores on the Parental Stress Scale (continuous scale).
    6) Parental reflectivity rated by parental reflective functioning questionnaire (PRFQ) and Parenting Sense of Competence scale (PSOC) (continuous scale).
    7) Predictive value of composite gene transcription and DNA methylation marker for estrogen sensitivity based on 116 a priori defined gene transcriptions.
    8) Mother's sleep quality rated by score on Pittsburgh Sleep Quality Index (PSQI) (continuous scale).
    9) Cognitive function rated by Symbol Digit Modalities Test (Processing Speed, Working Memory, SDMT), Rey's Auditory Verbal Learning Task (Memory, Working Memory, RAVLT), Letter-Number Sequence (Working Memory, LNS) and Emotional Intensity Morphing Test (EIMT).
    10) Cortisol dynamics measured as cortisol awakening response (AUC from 0-60 minutes after awakening measured from value upon awakening).
    11) Cortisol amount in hair sample from mother.
    12) Epigenetic markers for HPA axis control (stress hormone axis) from child.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) 8-10 weeks postpartum.
    2) 8-10 weeks postpartum.
    3) 8-10 weeks postpartum.
    4) 8-10 weeks postpartum.
    5) 8-10 weeks postpartum.
    6) 8-10 weeks postpartum.
    7) 3-4 weeks postpartum.
    8) 8-10 weeks postpartum.
    9) 8-10 weeks postpartum.
    10) 3-4 weeks postpartum.
    11) 0-1 days postpartum.
    12) 0-1 days postpartum.
    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 No
    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. 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 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 No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months5
    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 Yes
    F.1.1Number of subjects for this age range: 220
    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) Yes
    F. of subjects for this age range: 220
    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: 220
    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 No
    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 No
    F.3.3.4Nursing women Yes
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F. of subjects incapable of giving consent
    Saliva samples and body weights from infants of mothers participating in the clinical trial will be collected with informed consent from both parents
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state220
    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)
    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 Decision2020-06-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-11-17
    P. End of Trial
    P.End of Trial StatusOngoing
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