Major Depressive Disorder
Conditions
Keywords
Major Depressive Disorder, tDCS, MDD, transcranial Direct Current Stimulation
Brief summary
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
Detailed description
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.
Interventions
DEVICEYband(YDT-201N)
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)
DEVICESham-Yband(YDT-201N)
transcranial Direct Current Stimulation (tDCS) 2mA for 30 sec; left (anode) and right (cathode) Dorsolateral prefrontal cortex (DLPFC)
Sponsors
Severance Hospital
Gangnam Severance Hospital
Myongji Hospital
CHA University
National Health Insurance Service Ilsan Hospital
Ajou University
Hallym University Medical Center
Ybrain Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in depressive symptoms as assessed by the Montgomery-Asberg Depression Rating Scale (MADRS) | from baseline to Week 6 | Measured by Montgomery-Åsberg Depression Rating Scale (MADRS) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effect of tDCS on Depressive Symptoms as assessed by the Montgomery-Asberg Depression Rating Scale (MADRS) | At 6 weeks after treatment. | The percentage of subjects whose MADRS score decreases over 50% against the base in week 6 after treatment. |
| Effect of tDCS on questionnaire results as assessed by the Montgomery-Asberg Depression Rating Scale (MADRS) | At 6 weeks after treatment | The percentage of subjects whose MADRS score is under 10 in week 6 after treatment. |
| 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) | 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. |
| Average change in results for 2, 4, 6 weeks after treatment as assessed by Korean-Beck Depression Inventory-II (K-BDI-II) | 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. |
| Average change in results for 2, 4, 6 weeks after treatment as assessed by Korean-Beck Anxiety Depression Inventory (K-BAI) | 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. |
Countries
South Korea
Outcome results
None listed