treatment-resistant depression
Conditions
Interventions
Test group:deep brain stimulation of the nucleus accumbens and the anterior limb of the internal capsule (NAcc/ALIC-DBS)
Sponsors
The First Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-65 years; 2. Met the diagnostic criteria of depression in the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5); 3. Hamilton Depression Rating Scale-17 (HAMD-17) score >= 21; 4. Met the criteria of treatment-resistant: (1) Poor response to antidepressants of at least 3 different classes (SSRI, SNRI, TCA, mirtazapine, nefazodone, trazodone, bupropion, etc.) (maximum tolerated dose for more than 8 weeks); (2) Poor response to combination or synergistic treatment with at least 2 different mechanisms of antidepressants (atypical antipsychotics, lithium, thyroxine tablets, etc.); (3) Poor efficacy of adequate trials of cognitive behavioral therapy.
Exclusion criteria
Exclusion criteria: 1. Comorbid schizophrenia spectrum and other mental disorders, bipolar disorder, and other types of personality disorders; 2. Severe neurological or somatic diseases; 3. Contraindications to neurosurgery; 4. Drug abuse or dependence; 5. Women who are pregnant or preparing to be pregnant or lactating; 6. Participants were participating in other clinical trials or had participated in a clinical trial within the past three months (excluding registration studies); 7. Those who were deemed unsuitable for the trial by the investigators; 8. Having a history of active epilepsy, having previously suffered damage to the cranial nervous system, stereotactic nucleus lesion surgery, and other obvious neurological defects; 9. It is difficult to control abnormal blood pressure and blood sugar, who are taking anticoagulant drugs or have clinical bleeding tendency before the operation, who have implanted artificial cochlea, cardiac pacemaker, cardiac defibrillator, who have implanted unilateral or bilateral similar products, or who have performed other surgical operations that the researchers believe have an impact on this test within half a year, and who have serious other somatic diseases and other contraindications for neurosurgery operations.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the reduction rate of the total score of HAMA-17 at the end of 6 months after stimulation compared with that at baseline;the incidence of adverse events; | — |
Secondary
| Measure | Time frame |
|---|---|
| the changes in scores of HAMD-17 after stimulation compared with that at baseline;the changes in scores of MADRS after stimulation compared with that at baseline;the changes in scores of C-SSRS after stimulation compared with that at baseline;the changes in scores of CGI after stimulation compared with that at baseline;the changes in scores of SF-36 after stimulation compared with that at baseline;the changes in scores of WHOQOL-BREF after stimulation compared with that at baseline; | — |
Countries
China
Contacts
Public ContactXianzhi Liu; Huirong Guo
The First Affiliated Hospital of Zhengzhou University
Outcome results
None listed