Clinical trial NCT06015425: tDCS in Depression in Perinatal Women
Official title: Real-world Data Collection and Real-world Evidence Clinical Demonstration Study of tDCS for the Treatment of Depression in Perinatal Women
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Depression
Pregnancy
Keywords: Transcranial Direct Current Stimulation
Depression
Pregnancy
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Severance Hospital
name: Ilsan Cha hospital
name: Bundang CHA Hospital
name: Ybrain Inc.
First posted: 2023-08-29
Enrollment: 125
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Korean-Beck Depression Inventory-II (K-BDI-II) score change for depressive symptoms
timeFrame: At 4 weeks after treatment
measure: Montgomery-Åsberg Depression Rating Scale (MADRS) score change for depressive symptoms
timeFrame: At 4 weeks after treatment
Secondary outcomes:
measure: Center for Epidemiologic Studies Depression Scale (CESD-R) score change for depressive symptoms
timeFrame: At 4 weeks after treatment
measure: Korean Version of Edinburgh Postnatal Depression Scale (K-EPDS) score change for depressive symptoms
timeFrame: At 4 weeks after treatment
Other outcomes:
measure: Actigraphy/Lifelog Service Use
timeFrame: At 4 weeks after treatment
measure: Korean version of the Insomnia Severity Index (ISI-K) score change for Insomnia
timeFrame: At 4 weeks after treatment
measure: Korean version of Depression Anxiety Stress Scales-21 items (K-DASS-21) score change for Depression, anxiety, and stress
timeFrame: At 4 weeks after treatment
measure: Obstetric questionnaire.
timeFrame: At 4 weeks after treatment
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Republic Of Korea
Study officials:
affiliation: Seoul National University Hospital
name: Hee Young Cho
role: STUDY_DIRECTOR
affiliation: Severance Hospital
name: san lee
role: PRINCIPAL_INVESTIGATOR
affiliation: Ilsan Cha hospital
name: Min-Kyoung Kim
role: PRINCIPAL_INVESTIGATOR
affiliation: Bundang CHA Hospital
name: Chun Il Park
role: PRINCIPAL_INVESTIGATOR
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