Major depressive episode
Conditions
Interventions
Control group:iTBS on target determined using the "5cm rule"
Sponsors
Peking University Sixth Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18–65 years, regardless of gender, and of Han ethnicity; 2. Outpatients or inpatients; 3. Currently diagnosed with Major Depressive Disorder (MDD) or Bipolar II Disorder, experiencing a non-psychotic depressive episode; 4. Hamilton Depression Rating Scale (HAMD-17) score >= 18; 5. Ineffective treatment with at least one adequately dosed and durational trial of an antidepressant; 6. Overall good health status as determined by medical history; 7. At least a junior high school education, no language or communication barriers, able to comply with assessment and treatment, and signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Current or past diagnosis of organic mental disorders, schizophrenia, schizoaffective disorder, intellectual disability, dementia, other cognitive disorders, alcohol or substance dependence, or Axis II disorders including personality disorders; 2. History of any psychotic symptoms during current or previous depressive episodes; 3. Severe suicidal tendency (Self-Rated Suicide Ideation Scale total score >= 17 or a suicide attempt or suicidal behavior within the past six months); 4. Presence of severe or unstable physical illnesses, or any current or past medical condition that, in the investigator’s judgment, may pose a risk to the participant or interfere with study results; 5. Narrow-angle glaucoma or a history of seizures; 6. History of cardiovascular disease, cardiac events, electroconvulsive therapy (ECT), known pregnancy and/or lactation, or plans for pregnancy; 7. Simultaneous participation in another clinical trial or unwillingness/inability to complete the full course of this study; 8. Exclusion of secondary depressive disorders caused by physical illnesses such as epilepsy, cardiovascular disease, pheochromocytoma, hyperthyroidism, or spontaneous hypoglycemia; 9. Contraindications for magnetic resonance imaging (MRI), including pregnancy, presence of a cardiac pacemaker, aneurysm clips, ferromagnetic implants, artificial metallic heart valves, alloy prostheses, metallic joints, insulin pumps, or neurostimulators; 10. Contraindications for transcranial magnetic stimulation (TMS), including the presence of intracranial metallic foreign bodies, cardiac pacemakers, cochlear implants, or increased intracranial pressure, as well as a history or family history of epilepsy prohibiting high-frequency stimulation; 11. Receipt of electroconvulsive therapy (ECT) or TMS treatment within the past year.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage Change in the Hamilton Rating Scale for Depression (HAMD-17); | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage Change in the Hamilton Rating Scale for Depression (HAMD-17);Percentage Change in the Hamilton Rating Scale for Depression (HAMD-17);cognition;Brain structural and functional connectivity; | — |
Countries
China
Contacts
Public ContactYuyanan Zhang; Tianzi Jiang
Peking University Sixth Hospital/ Institute of Mental Health; Institute of Automation, Chinese Academy of Sciences
Outcome results
None listed