Depressive Disorder
Conditions
Interventions
iTBS Stimulation Group 1:single-iTBS
iTBS Sham Stimulation Group 1:single-iTBS was administered using a sham stimulation coil.
Healthy Control:None
closed-loop iTBS Group:Closed-loop iTBS
iTBS Group2:iTBS
iTBS Sham Stimulation Group 2:iTBS was administered using a sham stimulation coil.
Depression Group:None
Sponsors
The Second Xiangya Hospital of Central South University
Eligibility
Sex/Gender
All
Age
12 Years to 60 Years
Inclusion criteria
Inclusion criteria: Inclusion Criteria: 1. Age 12–60 years, regardless of gender; 2. Diagnosis meets the diagnostic criteria for depression according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V); 3. HAMD-17 score >= 17; 4. Able to cooperate in completing the study-related questionnaires, assessments, examinations, and treatments; 5. The patient and their family fully understand the study procedures and content and agree to participate; both the patient and their family must sign the informed consent form. Inclusion Criteria for Healthy Controls: 1. No history of serious physical illness, head trauma, or neurological disease; 2. HAMD-17 score < 7; 3. No history of psychiatric episodes and no family history of mental disorders; 4. The participant and their family fully understand the study procedures and content and agree to participate; both the participant and their family must sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients with other severe systemic diseases (including severe cardiac, renal, and hepatic diseases); 2. Diagnosis of other severe psychotic symptoms, presence of suicidal ideation, self-harm, or suicidal behavior; 3. Individuals with alcohol or drug dependence; 4. Individuals with intellectual disability; 5. Individuals with metal implants in the body, such as pacemakers or intracranial electrodes, who have contraindications for MRI and iTBS; 6. Individuals who have received iTBS or MECT treatment within the past 6 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hamilton Depression Rating Scale (HAMD/HAM-D);Patient Health Questionnaire-9 (PHQ-9);Social cognitive task;EEG and its associated parameters;fNIRS related indicators;MRI related-indicators;HRV; | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical Global Impression Scale (CGI);Repeatable Battery for the Assessment of Neuropsychological Status, RBANS;Questionnaire for Assessing the Integrity of Blinding;Hamilton Anxiety Scale (HAMA);Athens Insomnia Scale (AIS);IMS-12;Mood VAS;Generalized Anxiety Disorder 7-item (GAD-7); | — |
Countries
China
Contacts
Public ContactShen Yanmei
The Second Xiangya Hospital of Central South University
Outcome results
None listed