Depression
Conditions
Interventions
Local injection treatment group:Local injection of esketamine into the caudate nucleus (Hb)
DBS treatment group:Habenular nucleus DBS for treatment-resistant depression
Sponsors
The First Medical Center of Chinese PLA General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Outpatient patients aged 18 to 45 years, regardless of gender; 2. Individuals meeting DSM-5 criteria for major depressive disorder, whether as a single episode or recurrent; 3. Those who have previously received or are currently undergoing ineffective treatment with two different antidepressants at recommended doses for at least 6 weeks; 4. During screening and baseline, a total score of =20 on the HDRS-17 scale or =22 on the MADRS scale, with no suicidal thoughts (score <3 on item 10 of the MADRS scale); 5.Participants must provide written informed consent and voluntarily agree to participate in this clinical study.
Exclusion criteria
Exclusion criteria: 1. Patients diagnosed with other mental disorders per DSM-5 criteria, including organic mental disorders, schizophrenia, bipolar disorder, anxiety disorders, and obsessive-compulsive disorders. 2. Depression episodes secondary to organic mental disorders due to systemic or neurological diseases, such as hypothyroidism-related depression. 3. Patients with a history of suicide attempts, currently high suicide risk, or a MADRS scale item 10 score of >=3 for suicidal ideation. 4. Patients whose MADRS score shows a baseline reduction of >=25% compared to screening. 5. Patients with a history of allergic reactions to escitalopram or similar psychiatric medications. 6. Patients with a history of severe or poorly controlled cardiovascular, liver, kidney, hematologic, endocrine, or respiratory diseases. 7. Patients with epilepsy or a single episode of febrile seizures in childhood. 8. Patients with significant physical or laboratory test abnormalities during screening or baseline, including: ALT or AST >1.5 times the upper normal limit; thyroid function indicators >1.1 times the normal range; serum creatinine >1.1 times the upper limit; or blood urea nitrogen exceeding normal values. 9. Clinically significant ECG abnormalities during screening or baseline, such as QTc interval >=450ms in men or >=470ms in women, as determined by the investigator. 10. Patients with allergic conditions or allergies to two or more food items or drugs. 11. Patients with alcohol or substance dependence within the last 6 months. 12. Pregnant or breastfeeding women, or women of childbearing age with a positive HCG test; male and female subjects not using effective contraception or planning to conceive within 3 months post-trial. 13. Patients who participated in another clinical trial within 30 days before signing informed consent for this study. 14. Any other conditions deemed by the investigator as unsuitable for participation in the clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hamilton Depression Rating Scale; | — |
Secondary
| Measure | Time frame |
|---|---|
| Hamilton Anxiety Rating Scale, HAMA;Young Mania Rating Scale, YMRS;Pittsburgh Sleep Quality Index, PSQI; | — |
Countries
China
Contacts
Public ContactZhiqiang Cui
Chinese PLA General Hospital
Outcome results
None listed