suicidal ideation in major depressive disorder
Conditions
Interventions
Deep brain target stimulation group:Deep brain stimulation
Cortical target stimulation group:Cortical target stimulation
Sham stimulation group:Pseudo-stimulation
Sponsors
Beijing An Ding Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Aged 18 to 65 years, of any gender, right-handed, with educational level of junior high school or above. 2.Meeting the diagnostic criteria for MDD without psychotic symptoms during the current episode, as assessed by the Chinese version of the MINI Version 7.0.2 in accordance with the DSM-5. 3.A score of >= 6 on the BSSI. 4.No antidepressant medication use prior to study enrollment; or completion of a 5-half-life washout period for prior antidepressants; or maintenance of a stable antidepressant monotherapy for at least 4 weeks prior to enrollment, with the treatment regimen remaining unchanged until the completion of 10 treatment sessions (over 1 week) after enrollment. 5.HAMD-17>=14; 6.No exposure to other neuromodulation therapies within 30 days prior to enrollment. 7.Provision of written informed consent by the participant after full understanding of all study-related information.
Exclusion criteria
Exclusion criteria: 1.Current or past diagnosis of any major psychiatric disorder other than MDD in accordance with the DSM-5, including neurodevelopmental disorders, neurocognitive disorders, schizophrenia and other psychotic disorders, bipolar disorder, obsessive-compulsive disorder, panic disorder, post-traumatic stress disorder, alcohol or substance dependence/abuse, and personality disorders. 2.Depressive episodes secondary to organic psychiatric disorders caused by systemic or neurological diseases; 3.Contraindications to tFUS or magnetic resonance imaging (MRI): presence of electronic or metallic implants within the body or intracranial regions traversed by the acoustic beam (including cardiac pacemakers, coronary stents, defibrillators, or MRI-incompatible neural stimulation devices); 4.Comorbidity with severe or unstable neurological diseases, or severe cardiovascular, respiratory, hepatic, renal, endocrine, hematological or other systemic diseases; patients with unstable vital signs; or any other condition deemed ineligible for the study by the investigators. 5.Pregnant or lactating women; patients unable to adopt appropriate contraceptive measures during the study period. 6.Patients with marked impulsivity or poor treatment cooperation. 7.Receipt of electroconvulsive therapy (ECT/modified ECT) within 6 months prior to study enrollment. 8.Participation in other clinical trials within 3 months prior to study enrollment. 9.Any other circumstance in which the participant is deemed unsuitable for the study by the investigators.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Treatment response rate at week 1;Remission rate at week 1;Adverse event;Cognitive function assessment;Electroencephalography (EEG) data;Assessment of other clinical symptoms;Magnetic resonance imaging (MRI) data; | — |
Primary
| Measure | Time frame |
|---|---|
| BSSI score reduction at week 1; | — |
Countries
China
Contacts
Public ContactGang Wang
Beijing An Ding Hospital, Capital Medical University
Outcome results
None listed