Status:
WITHDRAWN
PREGBRAIN - Magnetic Stimulation of the Brain in Depressed Pregnant Women
Lead Sponsor:
Uppsala University
Conditions:
Depression
Pregnancy Related
Eligibility:
FEMALE
18-50 years
Phase:
NA
Brief Summary
Background: Depression during pregnancy is common, afflicting 10-20% of pregnant women. Nevertheless, many women want to avoid antidepressant treatment during pregnancy, due to the possible impact on...
Eligibility Criteria
Inclusion
- Pregnant women over the age of 18 with a diagnosis of uni- or bipolar depression verified through a Mini International Neuropsychiatric Interview (M.I.N.I.) (44), and with unchanged medication the past month.
- Provision of signed informed consent form
Exclusion
- Epilepsy, conductive ferromagnetic or other magnetic sensitive metals implanted in the head or within 30 cm of the treatment coil (examples cochlear implants, implanted electrodes/stimulators, aneurysm clips or coils, stents and bullet fragments), implanted device that is activated or controlled in any way by physiological signals such as pacemakers, implantable cardioverter-defibrillators (ICD's), vagus nerve stimulators, wearable cardioverter-defibrillators, implanted mediation pumps, intracardiac lines, even when removed, addiction (illicit drugs or alcohol), pre-eclampsia/eclampsia, previous preterm birth and/or treatment with any medication that could lower the threshold for seizures.
- Any condition that seriously increases the risk of non-compliance or loss of follow-up
Key Trial Info
Start Date :
December 31 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 9 2024
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04867889
Start Date
December 31 2022
End Date
February 9 2024
Last Update
July 19 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Brain Stimulation Unit, Uppsala university hospital
Uppsala, Region Uppsala, Sweden, 75334