Ignite Creation Date:
2024-05-06 @ 7:27 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06015425
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-08-31
First Post:
2023-08-23
Brief Title:
tDCS in Depression in Perinatal Women
Sponsor:
Seoul National University Hospital
Organization:
Seoul National University Hospital
Study Overview
Official Title:
Real-world Data Collection and Real-world Evidence Clinical Demonstration Study of tDCS for the Treatment of Depression in Perinatal Women
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is Real-world dataRWD collection and Real-world evidenceRWE clinical demonstration study of Transcranial direct current stimulationtDCS for the treatment of depression in perinatal women Participants will apply tDCS by themselves for 4 weeks at home Researchers will compare Visit 1 to Visit 3 in one group
Detailed Description:
The prevalence of postpartum depression is known to be 10-20 but the number of people who actually experience postpartum depression is reported to be higher According to the 2018 survey on postpartum care by the Ministry of Health and WelfareKorea 503 of mothers experienced postpartum depression during the postpartum care period and 339 of mothers aged 9 to 20 months postpartum were at risk of postpartum depression
To this end since the 1980s safer and more effective depression methods such as tDCS and repetitive transcranial magnetic stimulation rTMS which are noninvasive brain stimulation methods using electricity and magnetism have been developed Research has begun as a treatment technique and rTMS has been approved for depression by the US FDA in 2008 and the Ministry of Food and Drug Safety in Korea in 2013 It is becoming
According to the report by Sreeraj 2016 tDCS monotherapy resulted in significant improvement in depressive and anxiety symptoms during pregnancy and reported that it is likely to build an evidence base to strengthen the clinical usefulness of tDCS during pregnancy
Therefore through the actual use application of tDCS for the treatment of depression in perinatal women who are in the blind spot of drug treatment RWD and RWE are collected
To this end since the 1980s safer and more effective depression methods such as tDCS and repetitive transcranial magnetic stimulation rTMS which are noninvasive brain stimulation methods using electricity and magnetism have been developed Research has begun as a treatment technique and rTMS has been approved for depression by the US FDA in 2008 and the Ministry of Food and Drug Safety in Korea in 2013 It is becoming
According to the report by Sreeraj 2016 tDCS monotherapy resulted in significant improvement in depressive and anxiety symptoms during pregnancy and reported that it is likely to build an evidence base to strengthen the clinical usefulness of tDCS during pregnancy
Therefore through the actual use application of tDCS for the treatment of depression in perinatal women who are in the blind spot of drug treatment RWD and RWE are collected
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None