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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04720040
• Other study ID #: YB_ST_SIT1902
• Status: Completed
• Phase: N/A
• Start date: December 23, 2019
• Est. completion date: October 15, 2020

Study information

• Verified date: January 2021
• Source: Ybrain Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: October 15, 2020
• Est. primary completion date: August 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major

Intervention

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)

Locations

Country	Name	City	State
Korea, Republic of	YBrain Inc.	Seongnam-si	Gyeonggi-do

Sponsors (7)

Lead Sponsor	Collaborator
Ybrain Inc.	Hallym University Medical Center, Inje University, Korea University, Seoul National University Bundang Hospital, Soonchunhyang University Hospital, The Catholic University of Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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