Maternal Mental Health (MAMA) Study. Short time treatment with female sex hormone to prevent postpartum depression in a high-risk group

Phase 1

• Conditions: Perinatal depression with postpartum onset; MedDRA version: 20.0Level: LLTClassification code 10056393Term: Postpartum depressionSystem Organ Class: 100000004873; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2020-001592-33-DK
• Lead Sponsor: Rigshospitalet

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-06-10
• Last Update Posted: 7 December 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 220

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

• 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br>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