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

NCT04720040 | Completed

• 1 other identifier: YB_ST_SIT1902
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Korean-Beck Anxiety Depression Inventory

  Weeks 0, 2, 4, and 6

• Hamilton Rating Scale for Depression

  Weeks 0, 2, 4, and 6

Study Arms (1)

YMS-201B

EXPERIMENTAL

transcranial Direct Current Stimulation (tDCS) application 5 \~7 days a week for 6 weeks (total of 30\~42 applications)

Device: Mind STIM

Interventions

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)

YMS-201B

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ybrain Inc.: lead
• The Catholic University of Korea: collaborator
• Inje University: collaborator
• Korea University: collaborator
• Seoul National University Bundang Hospital: collaborator
• Hallym University Medical Center: collaborator
• Soonchunhyang University Hospital: collaborator

Study Sites (1)

YBrain Inc.

Seongnam-si, Gyeonggi-do, 13449, South Korea

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2021
• First Posted: January 22, 2021
• Study Start: December 23, 2019
• Primary Completion: August 31, 2020
• Study Completion: October 15, 2020
• Last Updated: January 22, 2021

Record last verified: 2021-01

Locations

KR (1)