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New treatment option for Major Depressive Disorder
Official title Maternal Mental Health Trial
ClinicalTrials.gov ID: NCT04685148
What this study is testing
What is Transdermal patch estradiol?
Transdermal patch estradiol is an investigational medicine, being studied as a potential treatment for major depressive disorder.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 45, women only
You may be able to join if
- Singleton pregnant
- Prior history of perinatal depression
- Age between 18 and 45 years
You likely can't join if
- 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...
- 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
See the full eligibility criteria
- Singleton pregnant
- Prior history of perinatal depression
- Age between 18 and 45 years
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Copenhagen, Denmark
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 45 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Copenhagen, Denmark. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.