Depressive symptoms
Conditions
Interventions
Active stimulation group:Physical intervention treatment on the basis of taking drugs, double excitatory stimulation treatment parameters (first plexus mode followed by standard mode):
Plexus mode (50
Standard mode (16Hz, stimulation output intensity of 120% MT) stimulation time 2.5 seconds, 12 seconds interval, 70 repetitions
The above two sequences were performed consecutively, with a total number of pulses of 3400, the first sequence of 192 seconds, the latter sequence of 1003 seconds, and a total treatment time of 19 mi
Maintain pseudo stimulus group:Pseudo-stimulation on the basis of taking drugs.
Sponsors
Affiliated Kangning Hospital of Ningbo University
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1) Voluntary signing of informed consent form; 2) Age range: 18-55 years old, gender not limited; 3) Meets the DSM-5 diagnostic criteria for major depressive episodes, with single episodes (F32.1, F32.2) or recurrent episodes (F33.1, F33.2); 4) During the screening period, the total score of HAMD17 is greater than or equal to 24 points, while during the baseline period, the total score of HAMD17 is greater than or equal to 21 points; 5) Currently, patients who receive sufficient doses of a single antidepressant and have been using it for at least 6 weeks; 6) The patient's physical examination, medical history, vital signs, blood and urine routine, liver and kidney function, electrolytes, electrocardiogram, electroencephalogram and other indicators are normal; 7) After fully understanding the safety of transcranial magnetic stimulation (TMS), I am willing to actively cooperate with the treatment and obtain informed consent from myself and my family.
Exclusion criteria
Exclusion criteria: 1. Age 55 years old; 2. Have a history of severe physical illness and anxiety caused by other psychoactive substances and non-dependent substances; 3. Patients with metal or electronic devices built into their bodies, such as intracranial metal foreign bodies, cochlear implants, pacemakers, stents and other metal foreign bodies; 4. Have a risk of seizures, have previous craniocerebral diseases, head trauma, alcoholism, electroencephalogram abnormalities, MRI evidence of brain structural abnormalities, or have a family history of epilepsy; 5. Those who have psychotic symptoms and need to be combined with antipsychotic drugs; 6. Received ECT or other physical therapy within 2 months before enrollment; 7. Answered "yes" to questions 4 or 5 on the Columbia Suicide Severity Rating Scale (C-SSRS) suicidal ideation items during the screening period and considered to be at risk of suicide and violent behavior based on the investigator's clinical assessment; or those who have significant suicidal tendencies currently or within the past 12 months. 8. Pregnant women, lactating women, or women of childbearing age who have positive blood HCG/urine pregnancy test results during the screening period; or those who are unable to take effective contraceptive measures during the trial; or those who plan to conceive (grant) within 3 months of the start of the trial; 9. Those who are currently (or within the past 4 weeks) taking adequate amounts of benzodiazepines that may limit the effectiveness of TMS for more than 2 weeks or any dose of antiepileptic or anticonvulsant drugs; 10. Refusal to sign informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in scale before and after the intervention;Changes in neurotransmitters of interest in the blood before and after the intervention; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in electrophysiological markers before and after intervention; | — |
Countries
China
Contacts
Public ContactDongsheng Zhou
Affiliated Kangning Hospital of Ningbo University
Outcome results
None listed