Depressive
Conditions
Interventions
Bilateral sequential accelerated true TBS group:Active stimulation
Bilateral sequential acceleration pseudo-TBS group:Sham stimulation
Sponsors
Affiliated Kangning Hospital of Ningbo University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Age range: 18 - 65 years old; 2. According to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5), patients who have experienced non-psychotic severe depressive episodes and have a moderate to severe level of treatment resistance as measured by the Maudsley Staging Method (MSM); 3. Patients who have received treatment with at least two different types of antidepressants with different mechanisms of action, but have not achieved satisfactory results or responded to the treatment; 4. Total score of HAMD-24 > 20; 5. Patients who can complete the first 5-day accelerated iTBS treatment and have a response rate of 50%; 6. Right-handed; 7. Physical examination, medical history, vital signs, routine blood and urine tests, liver and kidney function tests, electrolytes, electrocardiogram, and electroencephalogram of the patient are all normal; 8. After fully understanding the safety of transcranial magnetic stimulation (TMS), the patient is willing to cooperate with the treatment and signs an informed consent form with both the patient and the family.
Exclusion criteria
Exclusion criteria: 1. Those with a history of severe physical illness and depression caused by psychoactive substances and non-addictive substances; 2. Patients with implanted metal or electronic devices in their bodies, such as intracranial metal foreign bodies, artificial cochlear implants, cardiac pacemakers and stents, etc.; 3. At risk of epileptic seizures, with previous cranial diseases, head trauma, alcohol abuse, abnormal electroencephalograms, MRI evidence of brain structural abnormalities, or a family history of epilepsy; 4. Those with psychotic symptoms requiring combined use of antipsychotic drugs; 5. Those who received other physical treatments such as TMS, tES, ECT within 2 months before enrollment. 6. Refusal to sign the informed consent form.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Scale Ratings: HAMD-24, MADRS, HAMA, BSI-CV, RBANS-HAP;Brain-Derived Neurotrophic Factor (BDNF); | — |
Secondary
| Measure | Time frame |
|---|---|
| Electrophysiological indicators; brain region activation, functional connectivity, cortical plasticity, etc.; | — |
Countries
China
Contacts
Public ContactLi Xingxing
Affiliated Kangning Hospital of Ningbo University
Outcome results
None listed