Effect of Self-administered tDCS in Patients With MDD
- Conditions
- Major Depressive Disorder
- Interventions
- Device: tDCS treatmentDrug: Antidepressant Drug(escitalopram)
- Registration Number
- NCT04543123
- Lead Sponsor
- Jeong-Ho Chae
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 58
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description active tDCS treatment group tDCS treatment 2mA of current was delivered during the 30 minutes of treatment sham tDCS treatment group tDCS treatment the current rose slowly for 30 seconds, descended for 30 seconds, and then remained at zero for 29 minutes sham tDCS treatment group Antidepressant Drug(escitalopram) the current rose slowly for 30 seconds, descended for 30 seconds, and then remained at zero for 29 minutes active tDCS treatment group Antidepressant Drug(escitalopram) 2mA of current was delivered during the 30 minutes of treatment
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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.
Trial Locations
- Locations (1)
Seoul St. Mary's Hospital, The Catholic University of Korea
🇰🇷Seoul, Korea, Republic of