Treatment-resistant depression
Conditions
Interventions
Multi-target group-Precision Therapy with Contextual Triggering:Multi-target iTBS with Contextual Triggering
Single-target group-Precision Therapy with Contextual Triggering:Single-target iTBS with Contextual Triggering
Single-target group with non-Contextual Triggering:Single-target iTBS
Sponsors
Beijing Anding Hospital Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1)Outpatients or inpatients;aged 18 to 65 years old, male or female;(2)Diagnostic for major depressive disorder according to DSM-5, with single or recurrent episodes, without psychotic symptoms;(3)Hamilton Depression Rating Scale (HAMD-17) total score = 17 at screening and baseline;(4)Based on the Massachusetts General Hospital Antidepressant Treatment Response Questionnaire (MGH-ATRQ), participants must exhibit clinically significant suboptimal responses to at least two antidepressants administered at adequate doses (as per standard therapeutic dosage) and durations (at least 6 weeks) during their treatment course (defined as less than 50% improvement in depressive symptoms, determined by consensus between the investigator and the participant);(5)Current antidepressant treatment regimen has been stable for more than 4 weeks;(6)No contraindications identified in the Transcranial Magnetic Stimulation Adult Safety Screen (TASS);(7)Understanding and voluntary participation in this study, able to comply with the treatment protocol, and sign the informed consent form.
Exclusion criteria
Exclusion criteria: (1)Diagnostic criteria for other psychiatric disorders according to DSM-5: neurodevelopmental disorders, bipolar and related disorders, anxiety disorders, obsessive-compulsive and related disorders, schizophrenia spectrum and other psychotic disorders, substance-related and addictive disorders, personality disorders, etc.; (2) A history of or currently presents with clinically significant physical illnesses, such as severe or unstable cardiovascular, respiratory, digestive, endocrine, urinary, hematologic, neurological disorders, or conditions deemed by the researcher to pose potential risks to the patient's safety or full participation in the study;(3) The researcher judges the patient to be at high risk of suicide at present;(4) Has any serious neurological disorder or impairment, including but not limited to: any condition possibly related to increased intracranial pressure, space-occupying brain lesions, history of seizures (except those induced by ECT treatment), cerebral aneurysm, Parkinson's disease, Huntington's disease, multiple sclerosis, severe head trauma with loss of consciousness;(5) Currently taking lorazepam at a daily dose greater than 2 mg (or an equivalent dose of other benzodiazepines) or any dose of antiepileptic drugs;(6) Has received systemic modified electroconvulsive therapy (MECT) or physical therapies such as transcranial magnetic stimulation (TMS), deep brain stimulation (DBS), vagus nerve stimulation (VNS) in the three months prior to screening;(7) Pregnant or lactating women;(8) Contraindications for MRI;(9) Other conditions deemed unsuitable for participation in this clinical trial by the researcher.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The response rate in each group at the end of week 3 (post-treatment): the proportion of participants with a >= 50% reduction in HAMD-17 total score from baseline; | — |
Secondary
| Measure | Time frame |
|---|---|
| The changes of scales in different treatment groups at visit point;The differences of scales in different treatment groups at visit point;remission rate;The changes of neuroimaging features; | — |
Countries
China
Contacts
Public ContactWang Jing
Beijing Anding Hospital Capital Medical University
Outcome results
None listed