Status:
RECRUITING
Maternal Mental Health Trial
Lead Sponsor:
Vibe G Frøkjær, MD, PhD
Collaborating Sponsors:
Herlev Hospital
Hvidovre University Hospital
Conditions:
Major Depressive Disorder
Postpartum Depression
Eligibility:
FEMALE
18-45 years
Phase:
PHASE1
PHASE2
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...
Detailed Description
Major depressive disorder affects twice as many women as men. Women are at increased risk for depression in life phases, where endogenous sex steroid hormone milieu changes; such as in puberty, during...
Eligibility Criteria
Inclusion
- Singleton pregnant
- Prior history of perinatal depression
- Age between 18 and 45 years
Exclusion
- 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
Key Trial Info
Start Date :
February 3 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2030
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT04685148
Start Date
February 3 2021
End Date
December 31 2030
Last Update
September 23 2021
Active Locations (1)
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1
Neurobiology Researc hUnit
Copenhagen, Denmark, 2100