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Completed

NCT Number: NCT02657980

The Effect of tDCS in Patients With Moderate to Severe Major Depressive Disorder

Study Type: Interventional Study Design: Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment

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Key information

Conditions

Major Depressive Disorder Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

19 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Ybrain

Seoul, South Korea

About this study

Patients will be randomized to receive either real or sham-tDCS as well as anti-depressant drugs. tDCS will be applied over the left (anode) and right (cathode) dorsolateral prefrontal cortex (DLPFC). Patients will visit the hospital to get tDCS administrations 5 days a week for 2 weeks. They will be evaluated every 2 weeks.

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 SCID-IV and MINI (without psychotic features)
  • Greater than 22 points of Montgomery-Asberg Depression Rating Scale
  • Aged 19 to 65.
  • Has provided informed consent

Exclusion criteria

  • Has other mental disorders diagnosed by Axis-I, except major depressive disorder (However, subject who is diagnosed as both major depressive disorder as well as anxiety disorder can participate the study.)
  • History of suicidal attempt in the last 6 months
  • Diagnosed with bipolar or psychotic major depressive disorder
  • Diagnosed with other depressive disorders: dysthymic disorder, and depressive disorders that are not elsewhere classified.
  • Has hypersensitivity to sertraline ingredients
  • A score of 5 or greater for the question #10 in MADRS
  • Diagnosed with closed angle glaucoma or has a history of glaucoma.
  • History of participation in other clinical trials within 30days.
  • A major and/or unstable medical or neurologic illness
  • Currently taking substances that contain sertraline, mono amine oxidase inhibitor, or pimozide
  • Pregnant or has a positive pregnancy serum test.

Treatment and study plan

Yband(YDT-201N)

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)

Sham-Yband(YDT-201N)

Device

transcranial Direct Current Stimulation (tDCS) 2mA for 30 sec; left (anode) and right (cathode) Dorsolateral prefrontal cortex (DLPFC)

Primary outcomes

  1. Change in depressive symptoms as assessed by the Montgomery-Asberg Depression Rating Scale (MADRS)

    Time frame: from baseline to Week 6

    Measured by Montgomery-Åsberg Depression Rating Scale (MADRS)

Secondary outcomes

  1. Effect of tDCS on Depressive Symptoms as assessed by the Montgomery-Asberg Depression Rating Scale (MADRS)

    Time frame: At 6 weeks after treatment.

    The percentage of subjects whose MADRS score decreases over 50% against the base in week 6 after treatment.

  2. Effect of tDCS on questionnaire results as assessed by the Montgomery-Asberg Depression Rating Scale (MADRS)

    Time frame: At 6 weeks after treatment

    The percentage of subjects whose MADRS score is under 10 in week 6 after treatment.

  3. Average change in results for 2, 4, 6 weeks after treatment as assessed by the clinician-rated Clinical Global Impression-Severity of Illness Scale (CGISI)

    Time frame: At 2 weeks, 4 weeks and 6 weeks after treatment

    Average change of CGISI at 2 weeks, 4 weeks and 6 weeks after treatment compare to the base respectively.

  4. Average change in results for 2, 4, 6 weeks after treatment as assessed by Korean-Beck Depression Inventory-II (K-BDI-II)

    Time frame: At 2 weeks, 4 weeks and 6 weeks after treatment

    Average change of K-BDI-II at 2 weeks, 4 weeks and 6 weeks after treatment compare to the base respectively.

  5. Average change in results for 2, 4, 6 weeks after treatment as assessed by Korean-Beck Anxiety Depression Inventory (K-BAI)

    Time frame: At 2 weeks, 4 weeks and 6 weeks after treatment

    Average change of K-BAI at 2 weeks, 4 weeks and 6 weeks after treatment compare to the base respectively.

Sponsors and collaborators

Lead sponsor

Ybrain Inc.

Industry

Collaborators

  • Ajou University
  • CHA University
  • Gangnam Severance Hospital
  • Hallym University Medical Center
  • Myongji Hospital
  • National Health Insurance Service Ilsan Hospital
  • Severance Hospital

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jan 18, 2016
Registry last updated
Jan 26, 2017

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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