The Efficacy and Safety of tDCS in Patients With Mild to Moderate Major Depressive Disorder

Using YMS-201B in Patients With Mild to Moderate Major Depressive Disorder To Evaluate Efficacy and Safety for the Effect of Improving Depressive Symptoms Open, Single-group, Multicenter Confirmatory Clinical Trial

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04720040

Enrollment

Registered

2021-01-22

Start date

2019-12-23

Completion date

2020-10-15

Last updated

2021-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression

Brief summary

This study evaluated the effectiveness and safety of improving depressive symptoms by applying tDCS for 6 weeks to patients with mild to moderate depression.

Detailed description

Patients received tDCS for 30 minutes with an intensity of 1.5 to 2 mA. tDCS was applied over the left (anode) and right (cathode) dorsolateral prefrontal cortex (DLPFC) 5\ 7 times a week and they were evaluated every 2weeks through questionnaires.

Interventions

DEVICEMind 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)

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to 65 Years

Healthy volunteers

Inclusion criteria

* Has a diagnosis of a major depressive disorder as confirmed by the DSM-V and MINI (without psychotic features) * Patients with a K-BDI-II score of 14 or more and 28 or less * In the case of patients who have previously administered antidepressants, antipsychotics, and anticonvulsants for at least 1 week, Patients with sufficient drug treatment periods of at least 5 times the drug half-life.

Exclusion criteria

* Patients diagnosed with Axis I disorders other than major depressive disorder * Patients diagnosed with other depressive disorders besides major depressive disorder * Patients who have attempted suicide within 6 months of screening * Patients who are considered to have problems with EEG and DC stimulation electrode attachment due to scalp deformity, inflammatory reaction, or other dermatological problems * Patients judged to have other reasons for prohibition of use of tDCS medical devices * Patients currently taking antidepressants

Design outcomes

Primary

Measure	Time frame	Description
Korean-Beck Depression Inventory-II	At 6 weeks after treatment.	Average change of K-BDI-II at 6 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.

Secondary

Measure	Time frame	Description
Korean-Beck Anxiety Depression Inventory	Weeks 0, 2, 4, and 6	The BAI contains 21 questions, each answer being scored on a scale value of 0 (not at all) to 3 (severely). Higher total scores indicate more severe anxiety symptoms.
Hamilton Rating Scale for Depression	Weeks 0, 2, 4, and 6	The HRSD has been criticized for use in clinical practice as it places more emphasis on insomnia than on feelings of hopelessness, self-destructive thoughts, suicidal cognitions and actions. This scale contained 17items and each item is scored on a 3 or 5point scale. The lower the total score, the better the symptoms.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026