Depression
Conditions
Interventions
Intervention Group:TI stimulation was administered 1–2 times daily, 20 minutes per session, for a total of 10 sessions over 5–7 consecutive days. The target brain region was the lateral habenula, with
Sponsors
The First Affiliated Hospital of Air Force Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Age between 18 and 65 years (inclusive), either sex; 2. Meets the diagnostic criteria for depressive disorder (6A7) in the International Classification of Diseases, 11th Revision (ICD-11), with either a single episode or recurrent episodes, without psychotic symptoms; 3. Hamilton Depression Rating Scale-17 (HAMD-17) score >=17, with current depressive episode lasting more than 2 weeks; 4. Patients who are drug-naïve at first onset, or patients with relapse who have not received antidepressants, anxiolytics, antipsychotics, or anticonvulsants in the past month, or patients with poor response to pharmacotherapy whose treatment regimen has remained unchanged in the past two months; 5. Possesses adequate listening, speaking, reading, writing, and comprehension abilities to complete study questionnaires; 6. Must have a co-residing legal guardian or family member (isolated living participants are not eligible); 7. Voluntarily participates in the trial and signs the informed consent form, and is able to comply with scheduled visits, treatment protocols, and assessments.
Exclusion criteria
Exclusion criteria: 1. Participants with any other psychiatric disorder according to the International Classification of Diseases, 11th Revision (ICD-11), excluding depressive disorder (e.g., neurodevelopmental disorders, schizophrenia or other primary psychotic disorders, mood disorders, anxiety and related disorders, obsessive-compulsive and related disorders, disorders due to substance use or addictive behaviors); however, participants with anxiety and related disorders will not be excluded if these are not the primary diagnosis; 2. Participants with cranial bone defects; or those with organic brain lesions (e.g., intracerebral hemorrhage, large-area cerebral infarction, encephalitis, epilepsy); 3. Participants who received any neuromodulatory physical therapy within the past 30 days, including but not limited to electroconvulsive therapy, deep brain stimulation, transcranial magnetic stimulation, or vagus nerve stimulation; 4. Participants with an active suicide plan, or who have attempted suicide within the past year; 5. Participants with contraindications to magnetic resonance imaging (MRI), such as implanted metallic or electronic devices (intracranial metallic foreign bodies, cochlear implants, cardiac pacemakers, etc.); 6. Participants who are currently pregnant or breastfeeding, or who plan to become pregnant or give birth during the trial period; 7. Participants currently enrolled in other interventional clinical trials; 8. Any other condition deemed by the investigator to be unsuitable for participation in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction rate in HAMD-17 score compared to baseline after 5-7 days of treatment.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Reduction rate in HAMD-17 score compared to baseline, and the proportion of participants with HAMD-17 score <7 at the end of week 2.;Changes in scores of MADRS, QIDS, HAMA, PSQI, YMRS, and CGI from baseline at the end of Days 5–7 and at Week 2.;Changes in functional magnetic resonance imaging (fMRI) and event-related potentials (ERP) at the end of Days 5–7; | — |
Countries
China
Contacts
Public ContactWang Huaning
The First Affiliated Hospital of Air Force Medical University
Outcome results
None listed