Real-world Data Collection and Real-world Evidence Clinical Demonstration Study of tDCS for the Treatment of Depression in Perinatal Women
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 125
- 试验地点
- 2
- 主要终点
- Korean-Beck Depression Inventory-II (K-BDI-II) score change for depressive symptoms
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Korean-Beck Depression Inventory-II (K-BDI-II) score change for depressive symptoms
时间窗: At 4 weeks after treatment
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.
Montgomery-Åsberg Depression Rating Scale (MADRS) score change for depressive symptoms
时间窗: At 4 weeks after treatment
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.
次要结局
- Center for Epidemiologic Studies Depression Scale (CESD-R) score change for depressive symptoms(At 4 weeks after treatment)
- Korean Version of Edinburgh Postnatal Depression Scale (K-EPDS) score change for depressive symptoms(At 4 weeks after treatment)
研究者
CHO HEE YOUNG
Professor
Seoul National University Hospital