Clinical trial NCT05539131: Demonstration Study of the Effect of the Transcranial Direct Current Stimulation (tDCS) on Depressed Patients
Official title: Demonstration Study of the Effect of the Transcranial Direct Current Stimulation (tDCS) for the Patients With Depression in Clinical Fields
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Depression
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2022-09-14
Enrollment: 198
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in depressive symptoms on Beck Depression Inventory-II (BDI-II) at week 13
timeFrame: 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)
measure: Change from baseline in depressive symptoms on Montgomery-Asberg Depression Rating Scale (MADRS) at week 13
timeFrame: 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)
Secondary outcomes:
measure: Change from baseline in depressive symptoms on Epidemiologic Studies Depression Scale Revised (CESD-R) at week 13
timeFrame: 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)
measure: Change from baseline in depressive symptoms on Hamilton Anxiety Scale (HAM-A) at week 13
timeFrame: 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)
measure: Change from baseline in depressive symptoms on Clinical Global Impression-Severity of Illness scale (CGI-SI) at week 13
timeFrame: 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)
measure: Change from baseline in depressive symptoms on Digit Symbol Substitution Test (DSST) at week 13
timeFrame: 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)
Other outcomes:
Locations:
city: Chuncheon
country: Korea, Republic of
facility: Hallym Univsity Chuncheon Sacred Heart Hospital
state: Gangwon
city: Goyang
country: Korea, Republic of
facility: National Health Insurance Service Ilsanhospital
state: Gyeonggi
city: Goyang
country: Korea, Republic of
facility: Myongji Hospital
state: Gyeonggi
city: Incheon
country: Korea, Republic of
facility: Catholic Kwandong University International St. Mary'S Hospital
state: Gyeonggi
city: Yongin
country: Korea, Republic of
facility: Yongin Severance Hospital, Yonsei University College of Medicine
state: Gyeonggi
Study officials:
affiliation: Severance Hospital
name: Woo Jung Kim
role: PRINCIPAL_INVESTIGATOR
References:
citation: Oh J, Jang KI, Jeon S, Chae JH. Effect of Self-administered Transcranial Direct Stimulation in Patients with Major Depressive Disorder: A Randomized, Single-blinded Clinical Trial. Clin Psychopharmacol Neurosci. 2022 Feb 28;20(1):87-96. doi: 10.9758/cpn.2022.20.1.87.
citation: Fregni F, Nitsche MA, Loo CK, Brunoni AR, Marangolo P, Leite J, Carvalho S, Bolognini N, Caumo W, Paik NJ, Simis M, Ueda K, Ekhitari H, Luu P, Tucker DM, Tyler WJ, Brunelin J, Datta A, Juan CH, Venkatasubramanian G, Boggio PS, Bikson M. Regulatory Considerations for the Clinical and Research Use of Transcranial Direct Current Stimulation (tDCS): review and recommendations from an expert panel. Clin Res Regul Aff. 2015 Mar 1;32(1):22-35. doi: 10.3109/10601333.2015.980944.
citation: Wang J, Luo H, Schulke R, Geng X, Sahakian BJ, Wang S. Is transcranial direct current stimulation, alone or in combination with antidepressant medications or psychotherapies, effective in treating major depressive disorder? A systematic review and meta-analysis. BMC Med. 2021 Dec 17;19(1):319. doi: 10.1186/s12916-021-02181-4.