Demonstration Study of the Effect of the Transcranial Direct Current Stimulation (tDCS) on Depressed Patients

Not Applicable

Recruiting

• Conditions: Depression
• Interventions: Device: transcranial direct current stimulation (tDCS)

• Registration Number: NCT05539131
• Lead Sponsor: Yonsei University

Brief Summary

Purpose of research: It aims to demonstrate the effectiveness of transcranial direct current stimulation (tDCS) in the clinical domain for patients with depression and to optimize home-based e-medication technology.

Detailed Description

As a home-based clinical empirical study of transcranial direct current stimulation for depressed patients, male and female subjects aged 19 to 65 who meet the criteria for mild and moderate Major depressive disorder (MDD) were enrolled, and real-world data (RWD) was obtained through self-application of transcranial direct current stimulation (tDCS) at home for 6 weeks. This is a study that secures and derives real-world evidence (RWE) that can be applied to clinical practice.

Study Timeline

• Study First Submitted: 2022-09-08
• Study First Submitted QC: 2022-09-13
• Study First Posted: 2022-09-14
• Study Start: 2022-11-04
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-24
• Last Update Posted: 2023-01-26
• Primary Completion: 2024-10-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 198

Inclusion Criteria

• Male and Female aged 19 to 65 with mild and moderate Major depressive disorder (MDD)

Exclusion Criteria

• Those diagnosed with Post-traumatic stress disorder (PTSD), Obsessive compulsive disorder (OCD), bipolar or psychotic major depressive disorder, high suicide risk, Electroencephalography (EEG) and DC stimulation electrode attachment problems (such as scalp deformity, inflammatory response or other dermatological problems), Transcranial direct current stimulation (tDCS) medical device taboos (such as head metal plate insertion), clinical trials that have been inadequate for clinical trials

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sham transcranial direct current stimulation (tDCS)	transcranial direct current stimulation (tDCS)	daily active transcranial direct current stimulation (tDCS) use for 3 weeks + daily sham transcranial direct current stimulation (tDCS) use for 3 weeks
active transcranial direct current stimulation (tDCS)	transcranial direct current stimulation (tDCS)	daily active transcranial direct current stimulation (tDCS) use for 6 weeks

Primary Outcome Measures

Name	Time	Method
Change from baseline in depressive symptoms on Beck Depression Inventory-II (BDI-II) at week 13	Screening Visit, Baseline, 18~24 days from the baseline (Visit 2), 39~45 days from the baseline (Visit 3), 77~91 days from the baseline (Follow-up 1)	It is a self-report depression scale of 21 questions, which the score range from 0 to 63, and it is required to select a sentence that is appropriate for you among 4 descriptions for each question, and the total score is 0 to 63 points for each question. 0\~13: Minimal 14\~19: Mild depression 20\~28: Moderate depression 29\~63: Severe depression
Change from baseline in depressive symptoms on Montgomery-Asberg Depression Rating Scale (MADRS) at week 13	Screening Visit, Baseline, 18~24 days from the baseline (Visit 2), 39~45 days from the baseline (Visit 3), 77~91 days from the baseline (Follow-up 1)	It evaluates 10 items such as apparent sadness, voluntarily reporting sadness, internal tension, sleep loss, loss of appetite, laziness, loss of feeling, pessimistic thinking, and suicide accident, and the total score is 0 to 60 points per question.; It evaluates 10 items such as apparent sadness, voluntarily reporting sadness, internal tension, sleep loss, loss of appetite, laziness, loss of feeling, pessimistic thinking, and suicide accident, and the total score is 0 to 60 points per question.; It evaluates 10 items such as apparent sadness, voluntarily reporting sadness, internal tension, sleep loss, loss of appetite, laziness, loss of feeling, pessimistic thinking, and suicide accident, and the total score is 0 to 60 points per question.; The total score ranges from 0 to 60 points. 0-6 indicate an absence of symptoms 7-19 Mild depression 20-34 Moderate depression 35-60 Severe depression

Secondary Outcome Measures

Name	Time	Method
Change from baseline in depressive symptoms on Epidemiologic Studies Depression Scale Revised (CESD-R) at week 13	Baseline, 18~24 days from the baseline (Visit 2), 39~45 days from the baseline (Visit 3), 77~91 days from the baseline (Follow-up 1)	Epidemiologic Studies Depression Scale Revised test was revised to reflect the major depressive illustration diagnostic criteria for the evaluation of depression. Items reflecting anaesthesia, mental exercise delay/anxiety, and suicide accidents have been added, and are measured as 0 to 4 points per question on a self-report 20 question scale. The score ranges from 0\~80 points. . A score equal to or above 16 indicates a person at risk for clinical depression.
Change from baseline in depressive symptoms on Hamilton Anxiety Scale (HAM-A) at week 13	Baseline, 18~24 days from the baseline (Visit 2), 39~45 days from the baseline (Visit 3), 77~91 days from the baseline (Follow-up 1)	The scale developed by Hamilton consists of 14 questions, and is evaluated by the clinician on a 5-point Likert scale of a semi-structured interview tool. The score ranges from 0\~56 points. Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where \<17 indi- cates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.
Change from baseline in depressive symptoms on Clinical Global Impression-Severity of Illness scale (CGI-SI) at week 13	Baseline, 18~24 days from the baseline (Visit 2), 39~45 days from the baseline (Visit 3), 77~91 days from the baseline (Follow-up 1)	It was developed for evaluation of symptom severity, treatment response, and treatment effectiveness in patients with psychiatric disorders (Guy W, 1976) and scored 0-7 points based on the overall impression of the subject's symptoms and treatment response compared to typical patients with the disease.; It was developed for evaluation of symptom severity, treatment response, and treatment effectiveness in patients with psychiatric disorders (Guy W, 1976) and scored 0-7 points based on the overall impression of the subject's symptoms and treatment response compared to typical patients with the disease. The score ranges from 0\~7 points. 1: normal, not at all ill 2: borderline mentally ill 3: mildly ill 4: moderately ill 5: markedly ill 6: severely ill 7: extremely ill
Change from baseline in depressive symptoms on Digit Symbol Substitution Test (DSST) at week 13	Baseline, 18~24 days from the baseline (Visit 2), 39~45 days from the baseline (Visit 3), 77~91 days from the baseline (Follow-up 1)	t is possible to measure high-dimensional cognitive functions such as perceptual organization ability and visual movement coordination, and examine attentional concentration, visual short-term memory, and mental movement speed. A post-marketing survey (PMS) on a new mechanism of anti-depressant (vortioxetine) is used to measure cognitive function before and after the use of the antidepressant in depressed patients. The score is the number of correct number-symbol matches achieved in 90 s. The score ranges from 0\~93 points.

Trial Locations

Locations (5)

Yongin Severance Hospital, Yonsei University College of Medicine; 🇰🇷 Yongin, Gyeonggi, Korea, Republic of

National Health Insurance Service Ilsanhospital; 🇰🇷 Goyang, Gyeonggi, Korea, Republic of

Myongji Hospital; 🇰🇷 Goyang, Gyeonggi, Korea, Republic of

Hallym Univsity Chuncheon Sacred Heart Hospital; 🇰🇷 Chuncheon, Gangwon, Korea, Republic of

Catholic Kwandong University International St. Mary'S Hospital; 🇰🇷 Incheon, Gyeonggi, Korea, Republic of