Depression, Pregnancy
Conditions
Keywords
Transcranial Direct Current Stimulation, Depression, Pregnancy
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 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.
Interventions
DEVICEMINDD 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)
Sponsors
Severance Hospital
Ilsan Cha hospital
Bundang CHA Hospital
Ybrain Inc.
Seoul National University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
19 Years to 50 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Korean-Beck Depression Inventory-II (K-BDI-II) score change for depressive symptoms | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Center for Epidemiologic Studies Depression Scale (CESD-R) score change for depressive symptoms | At 4 weeks after treatment | 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. |
| Korean Version of Edinburgh Postnatal Depression Scale (K-EPDS) score change for depressive symptoms | At 4 weeks after treatment | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Actigraphy/Lifelog Service Use | At 4 weeks after treatment | Tracking parameters such as sleep stages, score, mode, etc. And Evaluation using an application through CESD-R , previously developed by the research team. |
| Korean version of the Insomnia Severity Index (ISI-K) score change for Insomnia | At 4 weeks after treatment | It is a questionnaire to evaluate the severity of insomnia and consists of a total of 7 questions. The total score ranges from 0 to 28, and a score of 15 or more, the cutoff point, is considered to be insomnia. |
| Korean version of Depression Anxiety Stress Scales-21 items (K-DASS-21) score change for Depression, anxiety, and stress | At 4 weeks after treatment | It consists of a total of 21 questions, each with 7 questions for depression, anxiety, and stress, and the response to each question was selected from 0 points (not applicable at all) to 3 points (very much applicable). Each depression, anxiety, and stress subscore is obtained by summing up the scores of the corresponding items, and each score represents an individual's level of depression, anxiety, and stress. |
| Obstetric questionnaire. | At 4 weeks after treatment | Obstetrics-related information was evaluated using questionnaires on general characteristics of pregnant women, pregnancy preparation questionnaires, and quarterly morning sickness questionnaires. |
Countries
South Korea
Contacts
Primary ContactHee Young Cho
Outcome results
None listed