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

NCT04720040 — Not applicable, Completed, 65 participants, Ybrain Inc.

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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

Registry	NCT04720040
Status	Completed
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, treatment
Enrollment	65 (Actual)
Sponsor	Ybrain Inc. (Industry); collaborators: The Catholic University of Korea, Inje University, Korea University, Seoul National University Bundang Hospital, Hallym University Medical Center, Soonchunhyang University Hospital
Conditions	Depression
Interventions	Mind STIM (Device)
Dates	start 2019-12-23, primary completion 2020-08-31, completion 2020-10-15, first posted 2021-01-22, last updated 2021-01-22
Locations	1 site in South Korea

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
YMS-201B	Experimental	Device: Mind STIM	transcranial Direct Current Stimulation (tDCS) application 5 \~7 days a week for 6 weeks (total of 30\~42 applications)

Mind STIM (Device): 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)

+Outcome measures

Primary outcomes

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 outcomes

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.

+Eligibility

Sex: All, ages: 19 Years to 65 Years

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

+Locations (1)

Facility	City	Country	Status
YBrain Inc.	Seongnam-si, Gyeonggi-do	South Korea