NCT04685148 Maternal Mental Health Trial
| NCT ID | NCT04685148 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Vibe G Frøkjær, MD, PhD |
| Condition | Major Depressive Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 220 participants |
| Start Date | 2021-02-03 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 220 participants in total. It began in 2021-02-03 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Perinatal depression affects 10-15% of women postpartum and has a recurrence rate of 40%. Women who develop perinatal depression might be particularly susceptible to the rapid and large changes in sex steroid hormones, particularly estradiol, across pregnancy to postpartum. This trial aims 1) to evaluate the preventive effect of transdermal estradiol treatment in the immediate postpartum on depressive episodes in a subgroup of women at high-risk for perinatal depression, and 2) to determine if a set of biomarker gene transcripts can identify this subgroup and thus form the basis for future personalised prevention or treatment. The MAMA Trial is a double-blind, 1:1 randomised, placebo-controlled trial. The trial involves maternity wards at three university hospitals in the Capital Region of Denmark. Women who are singleton pregnant in the third trimester with a prior history of perinatal depression are eligible to participate. Participants will be randomised to either estradiol patches (200 μg per day) or placebo patches for three weeks starting immediately postpartum. The primary statistical analysis will be performed based on the intention-to-treat principle. A sample size of 220 will provide the trial with 80% power (alpha 0.05, beta 0.2) to detect a reduction in postpartum depression of 50% and to tolerate a drop-out of around 20%.
Eligibility 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
Contact & Investigator
Vibe Gedsø Frøkjær, MD, PhD
PRINCIPAL INVESTIGATOR
Neurobiology Research Unit, copenhagen University hospital, Rigshospitalet, Denmark
Frequently Asked Questions
Who can join the NCT04685148 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 45 Years, studying Major Depressive Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04685148 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT04685148 currently recruiting?
Yes, NCT04685148 is actively recruiting participants. Contact the research team at vibe@nru.dk for enrollment information.
Where is the NCT04685148 trial being conducted?
This trial is being conducted at Copenhagen, Denmark.
Who is sponsoring the NCT04685148 clinical trial?
NCT04685148 is sponsored by Vibe G Frøkjær, MD, PhD. The principal investigator is Vibe Gedsø Frøkjær, MD, PhD at Neurobiology Research Unit, copenhagen University hospital, Rigshospitalet, Denmark. The trial plans to enroll 220 participants.