tDCS in Depression in Perinatal Women

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Depression, Pregnancy

Intervention / Treatment
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* Device: MINDD STIM+


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: YMS-201B+<br>transcranial Direct Current Stimulation (tDCS) application 5  7 days a week for 4 weeks (total of 20 28 applications) | Device: MINDD STIM+<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Korean-Beck Depression Inventory-II (K-BDI-II) score change for depressive symptoms | Average change of K-BDI-II at 4 weeks after treatment compare to the base respectively. This scale contains 21 questions, each answer being scored on a scale value of 0 to 3. Higher total scores indicate more severe depressive symptoms.The lower the total score, the better the symptoms. | At 4 weeks after treatment | 
| Montgomery-Åsberg Depression Rating Scale (MADRS) score change for depressive symptoms | It is evaluated on 10 items, including outward sadness, spontaneously reported sadness, internal tension, sleep deprivation, loss of appetite, difficulty concentrating, laziness (boredom), loss of feeling, pessimistic thoughts, and suicidal thoughts. It is evaluated as  6 points, and the total score is 0 60 points, and the change in score after 4 weeks is the Primary Outcome Measure. | At 4 weeks after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Center for Epidemiologic Studies Depression Scale (CESD-R) score change for depressive symptoms | The CESD developed by Radloff et al. in 1977 for the evaluation of depressive symptoms was revised to reflect the diagnostic criteria for major depressive episodes in the DSM-IV (Eaton, 2004). Dysphoria, anhedonia, psychomotor retardation/agitation, suicide Items reflecting accidents have been added. Self-report 20-item scale, each item measured from 0 to 4 points and the change in score after 4 weeks is the Secondary Outcome Measures. | At 4 weeks after treatment | 
| Korean Version of Edinburgh Postnatal Depression Scale (K-EPDS) score change for depressive symptoms | It evaluates the symptoms experienced while experiencing postpartum depression rather than a general depression test. It was developed by Cox et al. in 1987 and adapted and standardized in Korea by Kim Yong-gu et al. in 2005. With a total score of 30, a score of 10 or more, the cut-off point, is evaluated as having depressive symptoms and the change in score after 4 weeks is the Secondary Outcome Measures. | At 4 weeks after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transcranial Direct Current Stimulation, Depression, Pregnancy