Status:
UNKNOWN
tDCS in Depression in Perinatal Women
Lead Sponsor:
Seoul National University Hospital
Collaborating Sponsors:
Severance Hospital
Ilsan Cha hospital
Conditions:
Depression
Pregnancy
Eligibility:
FEMALE
19-50 years
Phase:
NA
Brief 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 depre...
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 postpart...
Eligibility Criteria
Inclusion
- Patients with mild to moderate MDD among perinatal women aged between 19 and 50 years of age
- MDD refers to cases that clinically satisfy the diagnostic criteria for unipolar and nonpsychotic major depressive disorder according to the 5th edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5).
- Mild and moderate symptoms are defined as non-severe conditions corresponding to a Beck Depression Inventory-II (BDI-II) score of 18 to 28 points or a Montgomery-Asberg Depression Rating Scale (MADRS) score of 14 to 34 points, which are the main evaluation variables.
- Those who can read and understand the subject explanation and consent form, and have Korean language proficiency at a level capable of responding to questionnaires
- In this study, since tDCS is not an absolute contraindication even for pregnant women, it is possible to participate in clinical demonstration studies unless the subject exclusion criteria are met.
Exclusion
- Male
- Those who have been diagnosed with Post-Traumatic Stress Disorder (PTSD) or Obsessive Compulsive Disorder (OCD) among psychiatric comorbid anxiety disorders
- Those diagnosed with bipolar or psychotic major depressive disorder
- Among those diagnosed with Seizure Disorders, those who are judged by the clinician to be inappropriate for this clinical trial
- A person who scores 5 or more in MADRS question 10 (suicidal ideation)
- A person who has attempted suicide within 6 months from the date of screening or a person who, as determined by the clinician, has a suicide risk that requires hospitalization in a protective ward
- Those who are judged to have problems with EEG and DC stimulation electrode attachment due to scalp deformities, inflammatory reactions, or other dermatological problems
- A person who is judged to have other reasons for prohibiting the use of tDCS medical devices (refer to the example below)
- A person who inserts a head metal plate
- Users of implantable medical devices such as pacemakers and implantable cardioverter defibrillators.
- Wearers of life-sustaining medical devices such as artificial heart lungs or users of implantable medical devices such as electrocardiographs
- Those who show clinically serious disorders in the cardiovascular system, digestive system, respiratory system, endocrine system, and central nervous system that affect the application and effectiveness evaluation of medical devices during the study period (e.g., those who have difficulty breathing while sitting still) If you have an endocrine system/central nervous system disease that is not controlled by medication, etc.)
- Those who participated in other clinical trials within 30 days from the date of screening
- Those who have applied transcranial direct current stimulation within 6 months from the date of screening
- In addition to the above, those who have clinically significant findings that are considered inappropriate for this clinical demonstration study as determined medically by the investigator or person in charge
Key Trial Info
Start Date :
October 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
125 Patients enrolled
Trial Details
Trial ID
NCT06015425
Start Date
October 1 2023
End Date
December 31 2025
Last Update
August 31 2023
Active Locations (1)
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1
Seoul National University Hospital
Seoul, Republic of Korea, South Korea, 03080