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tDCS in Depression in Perinatal Women

Primary Purpose

Depression, Pregnancy

Status
Not yet recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
MINDD STIM+
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Transcranial Direct Current Stimulation, Depression, Pregnancy

Eligibility Criteria

19 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

YMS-201B+

Arm Description

transcranial Direct Current Stimulation (tDCS) application 5 ~7 days a week for 4 weeks (total of 20~28 applications)

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
August 23, 2023
Last Updated
August 29, 2023
Sponsor
Seoul National University Hospital
Collaborators
Severance Hospital, Ilsan Cha hospital, Bundang CHA Hospital, Ybrain Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT06015425
Brief Title
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2023 (Anticipated)
Primary Completion Date
March 1, 2024 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
Collaborators
Severance Hospital, Ilsan Cha hospital, Bundang CHA Hospital, Ybrain Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Pregnancy
Keywords
Transcranial Direct Current Stimulation, Depression, Pregnancy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
125 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
YMS-201B+
Arm Type
Experimental
Arm Description
transcranial Direct Current Stimulation (tDCS) application 5 ~7 days a week for 4 weeks (total of 20~28 applications)
Intervention Type
Device
Intervention Name(s)
MINDD STIM+
Intervention Description
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)
Primary Outcome Measure Information:
Title
Korean-Beck Depression Inventory-II (K-BDI-II) score change for depressive symptoms
Description
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.
Time Frame
At 4 weeks after treatment
Title
Montgomery-Åsberg Depression Rating Scale (MADRS) score change for depressive symptoms
Description
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.
Time Frame
At 4 weeks after treatment
Secondary Outcome Measure Information:
Title
Center for Epidemiologic Studies Depression Scale (CESD-R) score change for depressive symptoms
Description
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.
Time Frame
At 4 weeks after treatment
Title
Korean Version of Edinburgh Postnatal Depression Scale (K-EPDS) score change for depressive symptoms
Description
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.
Time Frame
At 4 weeks after treatment
Other Pre-specified Outcome Measures:
Title
Actigraphy/Lifelog Service Use
Description
Tracking parameters such as sleep stages, score, mode, etc. And Evaluation using an application through CESD-R , previously developed by the research team.
Time Frame
At 4 weeks after treatment
Title
Korean version of the Insomnia Severity Index (ISI-K) score change for Insomnia
Description
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.
Time Frame
At 4 weeks after treatment
Title
Korean version of Depression Anxiety Stress Scales-21 items (K-DASS-21) score change for Depression, anxiety, and stress
Description
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.
Time Frame
At 4 weeks after treatment
Title
Obstetric questionnaire.
Description
Obstetrics-related information was evaluated using questionnaires on general characteristics of pregnant women, pregnancy preparation questionnaires, and quarterly morning sickness questionnaires.
Time Frame
At 4 weeks after treatment

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Women who have a uterus and ovaries and are likely to become pregnant and give birth
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hee Young Cho
Phone
+82 10-4127-9823
Email
hycho.md@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hee Young Cho
Organizational Affiliation
Seoul National University Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
san lee
Organizational Affiliation
Severance Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Min-Kyoung Kim
Organizational Affiliation
Ilsan Cha hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Chun Il Park
Organizational Affiliation
Bundang CHA Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
State/Province
Republic Of Korea
ZIP/Postal Code
03080
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
Yes
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tDCS in Depression in Perinatal Women

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