Major Depressive Disorder
Conditions
Interventions
Online intervention group:Performing a self-referential processing task concurrently while receiving iTBS
Control Group:Active control group (receiving iTBS only, without the cognitive task)
Sponsors
Tianjin Anding Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18–60 years, right-handed, completed nine years of compulsory education, and able to read and understand Chinese text; 2. Meet the diagnostic criteria for a depressive episode according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5); 3. A score of >= 17 on the 17-item Hamilton Depression Rating Scale (HDRS-17), indicating moderate to severe depressive episode; 4. Maintain a stable regimen of antidepressant medication or remain medication-free for one week prior to enrollment, and maintain this status throughout the study period; 5. The participants and their legal guardians voluntarily participate in this study and sign the written informed consent form after fully understanding the nature, purpose, potential risks, and benefits of transcranial magnetic stimulation (TMS), the iTBS protocol, and the concurrent cognitive tasks; 6. Be able to comply with the study requirements, commit to maintaining a stable treatment regimen during the study period, and complete all assessments on time
Exclusion criteria
Exclusion criteria: 1. Individuals with bipolar disorder, other mental disorders, or neurological diseases; 2. Presence of contraindications to magnetic resonance imaging (MRI); 3. Presence of major or unstable physical illnesses; 4. Current substance abuse or dependence; 5. Previous receipt of transcranial magnetic stimulation (TMS) treatment; 6. High risk of suicide; 7. Presence of factors that may affect the administration of TMS treatment; 8. Participation in other clinical trials within the past six months; 9. Individuals unable to read or understand written text.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hamilton Depression Rating Scale-17 items; | — |
Secondary
| Measure | Time frame |
|---|---|
| Hamilton Anxiety Rating Scale;Columbia–Suicide Severity Rating Scale;Acceptance rates for positive and negative words;Resting-state and task-based fMRI;Clinical Global Impression scale;Global Assessment of Functioning;Patient health questionnaire-9 items;Beck Depression Inventory;Quick Inventory of Depressive Symptomatology Self-Report;THINC-integrated tool; | — |
Countries
China
Contacts
Public ContactLi Shen
Tianjin Anding Hospital
Outcome results
None listed