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

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

Study Overview

• Status: Completed
• Conditions: Depression
• Intervention / Treatment: Device: Mind STIM

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.

• Study Type: Interventional
• Enrollment (Actual): 65
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13449
      • YBrain Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: YMS-201B; transcranial Direct Current Stimulation (tDCS) application 5 ~7 days a week for 6 weeks (total of 30~42 applications)	Device: Mind 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	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.	At 6 weeks after treatment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Korean-Beck Anxiety Depression Inventory	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.	Weeks 0, 2, 4, and 6
Hamilton Rating Scale for Depression	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.	Weeks 0, 2, 4, and 6

Collaborators and Investigators

• Sponsor: Ybrain Inc.
• Collaborators: Seoul National University Bundang Hospital; Korea University; Inje University; The Catholic University of Korea; Soonchunhyang University Hospital; Hallym University Medical Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 23, 2019
• Primary Completion (ACTUAL): August 31, 2020
• Study Completion (ACTUAL): October 15, 2020

Study Registration Dates

• First Submitted: January 18, 2021
• First Submitted That Met QC Criteria: January 18, 2021
• First Posted (ACTUAL): January 22, 2021

Study Record Updates

• Last Update Posted (ACTUAL): January 22, 2021
• Last Update Submitted That Met QC Criteria: January 18, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: YB_ST_SIT1902

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No