Depression
Conditions
Interventions
Pseudo-stimulation group:Warm air stimulation, identical in appearance and sound to transcranial plasma stimulation, but without producing high-pressure plasma
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 were on a single serotonin reuptake inhibitor (SSRI) medication (fluoxetine, citalopram, escitalopram, paroxetine, sertraline, or fluvoxamine) prior to enrollment, with a daily dosage of =40 mg fluoxetine equivalent maintained for at least 4 weeks, and who continued the same treatment after enrollment without any changes in medication type or dosage. ? Screening and baseline Hamilton Depression Rating Scale (HDRS-17) score = 17. ? Willingness to sign an informed consent form.
Exclusion criteria
Exclusion criteria: (1) According to DSM-5 criteria: Participants with current or past diagnoses of bipolar disorder, schizophrenia, obsessive-compulsive disorder, personality disorders, intellectual disabilities, substance-induced mental disorders, organic mental disorders, or other psychiatric disorders. (2) Refractory depression: Patients with treatment-resistant depression who have had an insufficient response (=20% reduction in Hamilton Depression Rating Scale [HAMD] score) despite adequate treatment with two or more antidepressants. (3) Allergy to SSRIs: Individuals allergic to serotonin reuptake inhibitors (SSRIs) such as fluoxetine, sertraline, paroxetine, fluvoxamine, citalopram, and escitalopram. (4) Concurrent use of certain medications: Participants using benzodiazepines, valproic acid, serotonin 1A receptor agonists, or atypical antipsychotics. (5) Severe or unstable organic diseases: Individuals with a history of seizures, central nervous system tumors, acute head trauma, intracranial infections, hydrocephalus, or other severe or unstable organic conditions. (6) Pregnant or breastfeeding women: Individuals who are pregnant, breastfeeding, or planning to become pregnant in the near future. (7) Presence of certain implants: Individuals with cardiac pacemakers, cardiac electrodes, or brain stimulators. (8) Compromised skin integrity: Individuals with compromised skin integrity at the stimulation site (right dorsolateral prefrontal cortex [DLPFC] according to the EEG 10-20 system F6) or at EEG electrode sites due to trauma or other reasons. (9) History of suicide attempts: Individuals with a history of suicide attempts in the past year and a score of =3 on item 3 (suicide) of the Hamilton Depression Rating Scale (HDRS-17). (10) Recent physical treatments for depression: Participants who have undergone electroconvulsive therapy, transcranial magnetic stimulation, or transcranial electrical stimulation within the past 6 months. (11) Substance abuse or dependence: Individuals with substance abuse or dependence within the past 6 months. (12) Participation in other clinical studies: Participants currently involved in another interventional clinical study with an incomplete primary endpoint, or who have completed or withdrawn from another interventional clinical study within the past month. (13) Other conditions deemed inappropriate: Any other conditions that the investigator believes make participation in the study inappropriate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 17 items Hamilton Depression Rating Scale Score;Functional Connectivity Density; | — |
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;Patient Health Questionnaire-9 items;The evoked brain network connectivity evoked by transcranial magnetic stimulation ;Amplitude of low frequency fluctuation;Peripheral blood inflammatory cytokine levels;Regional Homogeneity; | — |
Countries
China
Contacts
Public ContactPenghui Song
Xuanwu Hospital, Capital Medical University
Outcome results
None listed