Effect of Self-administered tDCS in Patients With MDD
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Sham Comparator: sham tDCS treatment group the current rose slowly for 30 seconds, descended for 30 seconds, and then remained at zero for 29 minutes |
Device: tDCS 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).
Drug: Antidepressant Drug(escitalopram)
Participants in both active and sham groups were prescribed escitalopram in combination with tDCS treatment.
|
| Experimental: active tDCS treatment group 2mA of current was delivered during the 30 minutes of treatment |
Device: tDCS 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).
Drug: Antidepressant Drug(escitalopram)
Participants in both active and sham groups were prescribed escitalopram in combination with tDCS treatment.
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Has a diagnosis of a major depressive disorder as confirmed by the SCID-IV and MINI (without psychotic features)
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Greater than 22 points of Montgomery-Asberg Depression Rating Scale
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Aged 19 to 65.
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Has provided informed consent
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Has received Escitalopram as a combined antidepressant during the study period
Exclusion Criteria:
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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.)
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History of suicidal attempt in the last 6 months
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Diagnosed with bipolar or psychotic major depressive disorder
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Diagnosed with other depressive disorders: dysthymic disorder, and depressive disorders that are not elsewhere classified.
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Has hypersensitivity to Escitalopram ingredients
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A score of 5 or greater for the question #10 in MADRS
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Diagnosed with closed angle glaucoma or has a history of glaucoma.
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History of participation in other clinical trials within 30days.
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A major and/or unstable medical or neurologic illness
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Currently taking substances pimozide
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Pregnant or has a positive pregnancy serum test.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Seoul St. Mary's Hospital, The Catholic University of Korea | Seoul | Korea, Republic of | 06591 |
Sponsors and Collaborators
- Jeong-Ho Chae
- Ybrain Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- tDCS in MDD