Status:
COMPLETED
The Role of Sex Steroids and Serotonin Brain Dynamics in Perinatal Mental Health
Lead Sponsor:
Vibe G Frøkjær, MD, PhD
Collaborating Sponsors:
Center for Integrated Molecular Brain Imaging, Copenhagen, Denmak
Mental Health Services in the Capital Region, Denmark
Conditions:
Major Depressive Disorder
Perinatal Depression
Eligibility:
FEMALE
18-40 years
Brief Summary
Hormonal transitions such as across pregnancy and postpartum may trigger depressive episodes in some women. It is not known why, but estrogen sensitivity may play a critical role. A preclinical human ...
Detailed Description
Motivation: Major depressive disorder (MDD) affects twice as many women as men and women are at an increased risk during hormonal transition phases such as pregnancy and birth. A highly relevant subp...
Eligibility Criteria
Inclusion
- Age 18-40 years
- Healthy pregnant women planned to deliver by caesarean section due to breech position of the fetus or previous caesarean section.
Exclusion
- Current or previous severe psychiatric disorder such as psychotic disorders, eating disorder and bipolar disorder or current or previous psychiatric disorder requiring hospitalization.
- Current or previous neurological diseases, severe somatic disease, severe postpartum hemorrhage or use of medication that can interfere with study outcomes
- Severe disease or malformations in infants
- Obesity or underweight (pre-gestational BMI below 18 or above 35)
- Not fluent in Danish or severe visual or hearing impairments
- Earlier or present learning disabilities
- MRI contraindications (claustrophobia, metal implants)
- Previous exposure to radioactivity \> 10 millisievert (mSv) within the last year
- Alcohol or drug abuse
Key Trial Info
Start Date :
January 24 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2020
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03795688
Start Date
January 24 2019
End Date
December 1 2020
Last Update
December 17 2020
Active Locations (1)
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1
Rigshospitalet
Copenhagen, Denmark, 2100