NCT06015425

tDCS in Depression in Perinatal Women

Real-world Data Collection and Real-world Evidence Clinical Demonstration Study of tDCS for the Treatment of Depression in Perinatal Women

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 125 (estimated)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: Female
• Age: 19 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is Real-world data(RWD) collection and Real-world evidence(RWE) clinical demonstration study of Transcranial direct current stimulation(tDCS) 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 Welfare(Korea), 50.3% of mothers experienced postpartum depression during the postpartum care period, and 33.9% 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.

Conditions

• Depression
• Pregnancy

Interventions

Type	Name	Description
DEVICE	MINDD STIM+	transcranial Direct Current Stimulation (tDCS) 2mA for 30 min; 30 sec of ramp-up and -down; left (anode) and right (cathode) Dorsolateral prefrontal cortex (DLPFC)

Timeline

• Start date: 2023-10-01
• Primary completion: 2024-03-01
• Completion: 2025-12-31
• First posted: 2023-08-29
• Last updated: 2023-08-31

Locations

1 site across 1 country: South Korea