Major Depressive Disorder
Conditions
Brief summary
In this randomized, single-blinded clinical trial, 58 patients with major depressive disorder were assigned to active and sham tDCS stimulation groups in a 1:1 ratio, and treatment responses were evaluated biweekly over six weeks.
Detailed description
Patients were randomized to receive either real or sham-tDCS as well as anti-depressant drugs. tDCS was applied over the left (anode) and right (cathode) dorsolateral prefrontal cortex (DLPFC). Patients visited the hospital to get tDCS administrations 5 days a week for 2 weeks. They were evaluated every 2 weeks.
Interventions
DEVICEtDCS treatment
Participants visited the hospital four times (biweekly for two weeks). During their second visit, a research nurse instructed each participant on use of home-based tDCS equipment (YDS-301N; Ybrain Inc., Seongnam-si, Korea) and all participants thereafter conducted tDCS treatment at home once a day for 30 minutes (five times per week).
DRUGAntidepressant Drug(escitalopram)
Participants in both active and sham groups were prescribed escitalopram in combination with tDCS treatment.
Sponsors
Ybrain Inc.
Jeong-Ho Chae
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
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 * Has received Escitalopram as a combined antidepressant during the study period
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 Escitalopram 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 pimozide * Pregnant or has a positive pregnancy serum test.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hamilton Depression Scale (HAM-D) | Change from Baseline Hamilton Depression Scale at 6 weeks | Hamilton Depression Scale was deployed by a trained psychiatrist at every visit.With a total of 17 questions, the overall score is rated from 0 to 34, and higher total scores indicate more severe depression symptoms |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Beck Depression Inventory (BDI) | Weeks 0, 2, 4, and 6 | The self-rated scale of the Beck Depression Inventory (BDI) was completed by participants. With a total of 21 questions, the score is rated from 0 to 33, and higher total scores indicate more severe depression symptoms. |
| Montgomery-Asberg Depression Rating Scale | Weeks 0, 2, 4, and 6 | Montgomery-Asberg Depression Rating Scale was deployed by a trained psychiatrist at every visit. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60. |
| Beck Anxiety Inventory | Weeks 0, 2, 4, and 6 | Beck Anxiety Inventory was deployed by a trained psychiatrist at every visit. 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. The overall score ranges from 0 to 63. |
Countries
South Korea
Outcome results
None listed