Perinatal depression with postpartum onset MedDRA version: 20.0 Level: LLT Classification code 10056393 Term: Postpartum depression System Organ Class: 100000004873
Conditions
Interventions
Trade Name: Vivelle Dot
Pharmaceutical Form:
INN or Proposed INN: Estradiol
Other descriptive name: ESTRADIOL
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 200-
Sponsors
Rigshospitalet
Eligibility
Sex/Gender
All
Inclusion criteria
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. Are the trial subjects under 18? yes Number of subjects for this age range: 220 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 220 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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;Secondary Objective: 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.;Primary end point(s): Clinical depression according to DSM-V criteria.;Timepoint(s) of evaluation of this end point: Between 2 weeks and 6 months postpartum | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary 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. ;Timepoint(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. | — |
Countries
Denmark
Contacts
Public ContactNeurobiology Research Unit
Rigshospitalet
Outcome results
None listed