None listed
Conditions
Interventions
Medical Device : The subjects of the clinical trial, who were evaluated to meet the selection criteria and exclusion criteria in visit 1, are randomly assigned to a test group or a control group, and
electrical stimulation cannot be felt when used)
2) Controller: Sham instrument (power is turned on in the same structure as the instrument used in the test group, but current is cut off and no actua
Sponsors
LeeSol
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Those who meet all of the following described conditions are selected as subjects for clinical trials. 1) Patients aged 19 or older and under 65 years of age with mild and moderate major depressive disorders (if they are taking antidepressants, benzodiazepine-based tranquilizers, or non-benzodiazepine sleeping pills, and if they are continuously taking them for more than two months without any dose or change in drugs as of Visit 1, they can participate in the trial together) 2) DSM-5* A person who meets the diagnostic criteria for a major depressive disorder or has been diagnosed with a depressive episode of ICD-10 (F32) *Diagnostic and Statistical Manual of Mental Disorders (DMS-5): Diagnostic and Statistical Manual of Mental Disorders 3) A person with a MADRS score of 7 or more and 34 or less 4) A person who can read and understand the explanation and consent form of the clinical trial subject and who can respond to the questionnaire 5) A person who voluntarily decides to participate in this clinical trial and agrees in writing to the consent of the person subject to the clinical trial and can participate (including home treatment) in the period before the clinical trial
Exclusion criteria
Exclusion criteria: Those who meet one or more of the following described conditions are excluded from the clinical trial subjects. 1) A person who exhibits a clinical disability* to the cardiovascular system, digestive system, respiratory system, endocrine system, and central nervous system to the extent that it affects the application and effectiveness of medical devices *For example, if you have difficulty breathing while sitting still, if you have endocrine and central nervous system diseases that are not controlled by medication, chronic obstructive pulmonary disease, congestive heart failure, etc 2) a person diagnosed with alcohol dependence 3) A person who has attempted suicide within six months based on visit 1 or has a risk of suicide to the extent that he/she needs to be hospitalized in a protective ward 4) A person who has a history of psychiatric disorders (e.g., schizophrenia, bipolar disorder, anxiety disorder, post-traumatic stress disorder, intellectual development disorder, major neurocognitive disorder, substance use disorder, etc.) or a person who has a history of psychiatric hospitalization, excluding major depressive disorders, based on DSM-5 5) A person deemed to have other reasons for prohibiting use of clinical trial medical devices (a person with an implantable defibrillator implanted in the body or a medical device such as a metal implant in the head or neck) 6) A person deemed to have problems with electroencephalogram and AC stimulation electrodes due to abnormalities in the electrode attachment area, inflammatory reactions, or other dermatological problems 7) A person who has taken antidepressants, antipsychotics, and mood stabilizers for depression within two months based on visit 1 8) A person who has undergone cognitive behavioral therapy, recurrent transcranial magnetic stimulation, and electroconvulsions for depression within two months based on visit 1 9) Persons with moderate and severe headaches, tinnitus, convulsive diseases, etc 10) Women who do not agree to use contraception in a medically acceptable manner up to 6 weeks after application of the clinical trial medical device in this clinical trial *Medically accepted methods of contraception: condoms, oral contraception for at least three months, use of injectable or implanted contraceptives, etc 11) Pregnant or lactating woman 12) A person who is currently participating in another clinical trial or who has participated in another clinical trial within 30 days based on Visit 1 13) A person who judges that the tester is unfit to participate in the clinical trial due to other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MADRS change after 6 weeks compared to pre-treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| K-BDI-II change after 6 weeks compared to pre-treatment;K-BAI change after 6 weeks compared to pre-treatment;PSQI-K change in PSQI-K change capacity;ISI-K change in ISI-K changes in ISI-K change;Changes in WHOQOL-BREF after 6 weeks compared to pre-treatment;50% improvement rate of MADRS after 6 weeks compared to pre-treatment;MADRS 10-point remission rate after 6 weeks of treatment | — |
Countries
Korea, Republic of
Contacts
Public ContactIN YOUNG YOON
Seoul National University Bundang Hospital
Outcome results
None listed