treatment-resistant depression
Conditions
Interventions
deep brain stimulation group:deep brain stimulation
Sponsors
Shanghai Changhai Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Male and female patients, aged 18-60 years; 2. Sign the ICF; 3. Nationality: Han; 4. Can provide blood samples; 5. Meet the diagnostic criteria for moderate to severe depression in DSM-V; 6. Complete the 12-week follow-up study for confirmation of treatment-resistant depression. Note: Treatment-resistant depression is defined as patients who have no response to at least two different types of antidepressant drugs (one of which must be escitalopram oxalate) with adequate treatment durations and dosages.
Exclusion criteria
Exclusion criteria: 1. Patients with bipolar disorder, schizoaeefctive disorder, schizophrenia or other mental disorders; 2. Patients with severe intend of committing suicide; 3. Contraindications for antidepressant drugs or other psychotropic substances; 4. Patients who are not stable or require the combined treatment of other psychotropic substances(including antipsychotics, mood stabilizers, anticonvulsants and stimulants); 5. Patients who received improved electric shock treatment within 1 month after being studied and screened; 6. Patient with severe cognitive disorders (MMSE score: illiterate < 17, primary school < 20, middle school and above < 24); 7. History of intractable epilepsy; 8. Patients with severe heart, liver, kidney disease, or with severe hypertension, who are considered by the investigators that are not suitable for enrollment; 9. Patients with severe diabetes or diabetes with cardio-cerebral vascular disease; 10. Patients with confirmed malignant tumors; 11. Surgical contraindications (patients with cochlear implant, pacemaker, cardiac defibrillator, or have had stereotactic nucleus lesion surgery or implanted similar unilateral or bilateral products before) or had other surgical operations within 6 months which are considered by the investigators may have an impact on the trial, or other neurosurgical contraindications; 12. Patients who have suffered from traumatic brain injury before; 13. Patient who are taking anticoagulant drugs or having intracranial hemorrhage tendency; 14. Women who are pregnant or preparing for pregnancy, or in the lactation period; 15. Alcohol or drug abuser; 16. Patients who are participating in another clinical trial simultaneously or participated in other clinical trial within 3 months; 17. Patients who are considered by the investigators inappropriate to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hamilton's Depression Scale; | — |
Secondary
| Measure | Time frame |
|---|---|
| CGI;Beck Scale for Suicidal Ideation scores;HAMA;MMPI;PSQI;use of antidepressants; | — |
Countries
Chian
Contacts
Public ContactJianmin Liu
Shanghai Changhai Hospital
Outcome results
None listed