Preventing postpartum depression with estradiol treatment
Official title: Short Time Oestrogen as a Candidate Strategy to Prevent Postpartum Depression in a High-risk Group: a Randomised, Placebo-controlled Trial.
Run by Copenhagen University Hospital, Rigshospitalet · NCT04685148 · Data updated 2026-11-12
This study is testing if a skin patch with estradiol can help prevent postpartum depression in pregnant women who have a history of depression.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 45 Years |
| Sex | Women only |
| Enrollment | 220 (estimated) |
| Sponsor | Copenhagen University Hospital, Rigshospitalet Academic / other |
| Locations | 1 site (Copenhagen) |
| Status | Recruiting |
| Started | February 3, 2021 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2030 |
| Registry record updated | September 23, 2021 |
| Trial ID | NCT04685148 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are singleton pregnant women aged 18 to 45 with a prior history of perinatal depression.
✕Probably not a fit
Patients with moderate to severe depression during pregnancy or severe psychiatric disorders may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This trial evaluates the effectiveness of transdermal estradiol treatment in preventing depressive episodes in women at high risk for perinatal depression during the immediate postpartum period. It aims to identify a subgroup of women who are particularly sensitive to hormonal changes by analyzing biomarker gene transcripts. The study is a double-blind, randomized, placebo-controlled trial conducted in maternity wards at three university hospitals in the Capital Region of Denmark. Eligible participants are singleton pregnant women in their third trimester with a prior history of perinatal depression.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the incidence of postpartum depression in vulnerable women.
How similar studies have gone: Other studies have shown promise in using hormonal treatments for depression, but this specific approach is novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Singleton pregnant * Prior history of perinatal depression * Age between 18 and 45 years Exclusion Criteria: * Moderate to severe depression with onset during pregnancy * Severe psychiatric disorders (e.g. disorders with psychotic symptoms, schizophrenia, bipolar disorders, inpatient eating disorders and inpatient obsessive-compulsive disorders) * Previous suicide attempts without having a depressive episode * Prior history or ongoing neurological disorders (e.g. migraine or epilepsy) * Severe somatic illness * Prior history or ongoing cancer * Prior history of venous thromboembolism, myocardial infarction, cerebrovascular thromboembolism or thrombophilia, or other risk factors clinically assessed after thrombophilia screening * Deep vein thrombosis or pulmonary embolism in current pregnancy * Pregnancy-induced hypertension or preeclampsia * Pre-existing atherosclerosis or well-known cardiovascular risk factors (e.g. diabetes, hypertension) * Other contraindication for oestrogen treatment (e.g. acute liver failure, severe varicose veins) * Use of psychotropic pharmacology, except for short-term sleep support treatment * Non-fluent in Danish or pronounced vision or hearing loss * Body Mass Index (BMI) \>35 kg/m2 * Ongoing alcohol or drug abuse * Severe postpartum haemorrhage (\>1500 ml) * Severe illness in the infant or perinatal death
Where it's running
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Neurobiology Researc hUnit
Copenhagen, Denmark Recruiting
Study contacts
- Principal investigator: Vibe Gedsø Frøkjær, MD, PhD — Neurobiology Research Unit, copenhagen University hospital, Rigshospitalet, Denmark
- Study coordinator: Vibe Gedsø Frøkjær, MD, PhD
- Email: vibe@nru.dk
- Phone: +45 35456714
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.