Depressive symptoms
Conditions
Interventions
Sequential TBS maintenance verum stimulation group:Sequential active TBS
Sequential TBS maintenance sham stimulation group:Sequential sham TBS
Sponsors
Affiliated Kangning Hospital of Ningbo University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-65 years; 2.Patients experiencing a non-psychotic major depressive episode as defined the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) and measuring a moderate to severe level of treatment resistance using the Maudsley Staging (MSM). 3.Patients who have undergone at least two antidepressant medications with different mechanisms of action, at adequate doses and duration, with poor efficacy no response. 4.Total score on the 24-item Hamilton Rating Scale for Depression (HAMD-24) >20; 5.Patients who can complete the first 5-day accelerated sequential TBS treatment and achieve a 50% response rate; 6. Right-handed; 7.Normal physical examination, medical history, vital signs, routine blood, urine, and stool tests, liver and kidney function, electrolytes, electrocardiogram, electroencephalogram; 8. Fully understanding the safety of Transcranial Magnetic Stimulation (TMS), willing to cooperate with the treatment, and the informed consent form with both the patient and their family.
Exclusion criteria
Exclusion criteria: 1.Age 60 years; 2. History of severe physical illness and depression caused by other psycho substances and non-dependent substances; 3.Patients with metal or electronic devices in their bodies, such as intracranial metal foreign bodies, cochlear implants pacemakers, and metal stents; 4. Risk of epileptic seizures, history of cerebrocranial diseases, head injuries, alcoholism, abnormal, MRI evidence of abnormal brain structure, or family history of epilepsy; 5. Presence of psychotic symptoms requiring concurrent antipsychotic drugs; 6.ECT treatment within 2 months before enrollment; 7. Refusal to sign the informed consent form.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Depression detection; | — |
Secondary
| Measure | Time frame |
|---|---|
| magnetic resonance imaging;Near Infrared Imaging;Resting state/task state Electroencephalogram;Transcranial magnetoencephalography;Transcranial magneto-myography;Paired pulse stimulation;cognitive assessment;Suicide assessment;Anxiety testing;Sleep quality assessment; | — |
Countries
China
Contacts
Public ContactCHANG YU
Affiliated Kangning Hospital of Ningbo University
Outcome results
None listed