Depression
Conditions
Interventions
Depression group:We plan to conduct 4 weeks of transcranial plasma stimulation treatment (5 days per week, 30 minutes per day) on participants with depressive disorders. The target site for stimulatio
Sponsors
Xuanwu Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: ? Based on clinical evaluation and confirmation using the "Mini International Neuropsychiatric Interview (MINI 7.0)" questionnaire, meeting the diagnostic criteria for Major Depressive Disorder (MDD) as outlined in the Fifth Edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5), including first onset or recurrent episodes. ? Male or female, aged 18 years (inclusive) to 65 years (inclusive). ? Participants who have not received antidepressant medication for at least 3 weeks prior to enrollment. ? Screening and baseline Hamilton Depression Rating Scale (HDRS-17) score = 17. ? Willingness to sign an informed consent form."
Exclusion criteria
Exclusion criteria: ? Participants who currently or previously have been diagnosed with bipolar disorder, schizophrenia, obsessive-compulsive disorder, personality disorders, intellectual disabilities, substance-induced mental disorders, organic mental disorders, or other psychiatric disorders according to DSM-5 criteria. ? Participants with a history of severe or unstable organic diseases such as epilepsy, central nervous system tumors, acute head trauma or intracranial infections, hydrocephalus, etc. ? Pregnant or lactating women or those planning to become pregnant in the near future. ? Participants with implanted metal devices such as cardiac pacemakers. ? Participants with compromised skin integrity at the stimulation site. ? Participants with a history of suicide attempts within the past year or a score of =3 on item 3 (suicidal item) of the HDRS-17. ? Participants who have undergone brain stimulation or other physical treatments for depression, such as electroconvulsive therapy, transcranial magnetic stimulation, or transcranial electrical stimulation, within the past 6 months. ? Participants with a history of substance abuse/dependence within the past 6 months. ? Participants who are currently participating in another interventional drug or medical device clinical study that has not yet reached its primary endpoint, or who have completed/withdrawn from another interventional drug or medical device clinical study within the past month. ? Other circumstances deemed unsuitable for participation in this study by the investigator."
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 17 items Hamilton Depression Rating Scale Score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Quick Inventory of Depressive Symptomatology-Self-Report 16 Score;Hamilton Anxiety Scale Score;Generalized Anxiety Disorder 7 Score;Pittsburgh Sleep Quality Index;Peripheral blood inflammatory cytokine levels;Translocator Protein 18kDa uptake rate;PET-18F-MPPF Binding Potential; | — |
Countries
China
Contacts
Public ContactYicong Lin
Xuanwu Hospital, Capital Medical University
Outcome results
None listed