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Completed

NCT Number: NCT04720040

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

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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Key information

Conditions

Depression Behavior Behavioral Symptoms

Age range

19 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

YBrain Inc.

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

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

Primary outcomes

  1. Korean-Beck Depression Inventory-II

    Time frame: 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

  1. Korean-Beck Anxiety Depression Inventory

    Time frame: 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.

  2. Hamilton Rating Scale for Depression

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Ybrain Inc.

Industry

Collaborators

  • Hallym University Medical Center
  • Inje University
  • Korea University
  • Seoul National University Bundang Hospital
  • Soonchunhyang University Hospital
  • The Catholic University of Korea

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jan 22, 2021
Registry last updated
Jan 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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