The Efficacy and Safety of tDCS in Patients With Mild to Moderate Major Depressive Disorder
- Conditions
- Depression
- Registration Number
- NCT04720040
- Lead Sponsor
- Ybrain Inc.
- Brief Summary
This study evaluated the effectiveness and safety of improving depressive symptoms by applying tDCS for 6 weeks to patients with mild to moderate depression.
- Detailed Description
Patients received tDCS for 30 minutes with an intensity of 1.5 to 2 mA. tDCS was applied over the left (anode) and right (cathode) dorsolateral prefrontal cortex (DLPFC) 5\~7 times a week and they were evaluated every 2weeks through questionnaires.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 65
- Has a diagnosis of a major depressive disorder as confirmed by the DSM-V and MINI (without psychotic features)
- Patients with a K-BDI-II score of 14 or more and 28 or less
- In the case of patients who have previously administered antidepressants, antipsychotics, and anticonvulsants for at least 1 week, Patients with sufficient drug treatment periods of at least 5 times the drug half-life.
- Patients diagnosed with Axis I disorders other than major depressive disorder
- Patients diagnosed with other depressive disorders besides major depressive disorder
- Patients who have attempted suicide within 6 months of screening
- Patients who are considered to have problems with EEG and DC stimulation electrode attachment due to scalp deformity, inflammatory reaction, or other dermatological problems
- Patients judged to have other reasons for prohibition of use of tDCS medical devices
- Patients currently taking antidepressants
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Korean-Beck Depression Inventory-II At 6 weeks after treatment. Average change of K-BDI-II at 6 weeks after treatment compare to the base respectively. This scale contains 21 questions, each answer being scored on a scale value of 0 to 3. Higher total scores indicate more severe depressive symptoms.The lower the total score, the better the symptoms.
- Secondary Outcome Measures
Name Time Method Korean-Beck Anxiety Depression Inventory Weeks 0, 2, 4, and 6 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.
Hamilton Rating Scale for Depression Weeks 0, 2, 4, and 6 The HRSD has been criticized for use in clinical practice as it places more emphasis on insomnia than on feelings of hopelessness, self-destructive thoughts, suicidal cognitions and actions. This scale contained 17items and each item is scored on a 3 or 5point scale. The lower the total score, the better the symptoms.
Trial Locations
- Locations (1)
YBrain Inc.
🇰🇷Seongnam-si, Gyeonggi-do, Korea, Republic of
YBrain Inc.🇰🇷Seongnam-si, Gyeonggi-do, Korea, Republic of