tDCS in Depression in Perinatal Women

August 29, 2023 updated by: CHO HEE YOUNG, Seoul National University Hospital

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

125

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
    • Republic Of Korea
      • Seoul, Republic Of Korea, Korea, Republic of, 03080
        • Seoul National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Korean-Beck Depression Inventory-II (K-BDI-II) score change for depressive symptoms
Time Frame: 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.
At 4 weeks after treatment
Montgomery-Åsberg Depression Rating Scale (MADRS) score change for depressive symptoms
Time Frame: 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.
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
Time Frame: 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.
At 4 weeks after treatment
Korean Version of Edinburgh Postnatal Depression Scale (K-EPDS) score change for depressive symptoms
Time Frame: 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.
At 4 weeks after treatment

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Korean version of the Insomnia Severity Index (ISI-K) score change for Insomnia
Time Frame: 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.
At 4 weeks after treatment
Korean version of Depression Anxiety Stress Scales-21 items (K-DASS-21) score change for Depression, anxiety, and stress
Time Frame: 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.
At 4 weeks after treatment
Obstetric questionnaire.
Time Frame: 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.
At 4 weeks after treatment
Actigraphy/Lifelog Service Use
Time Frame: 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.
At 4 weeks after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

Severance Hospital
Bundang CHA Hospital
Ybrain Inc.
Ilsan Cha hospital

Investigators

  • Study Director: Hee Young Cho, Seoul National University Hospital
  • Principal Investigator: san lee, Severance Hospital
  • Principal Investigator: Min-Kyoung Kim, Ilsan Cha Hospital
  • Principal Investigator: Chun Il Park, Bundang CHA Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2023

Primary Completion (Estimated)

March 1, 2024

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

August 23, 2023

First Submitted That Met QC Criteria

August 23, 2023

First Posted (Actual)

August 29, 2023

Study Record Updates

Last Update Posted (Actual)

August 31, 2023

Last Update Submitted That Met QC Criteria

August 29, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HI23C0297

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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