Treatment-resistant depression
Conditions
Interventions
Observation group:None
Sponsors
Southern Medical University Hospital of Integrated Traditional Chinese and Western Medicine
Eligibility
Sex/Gender
All
Age
60 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1) Age 60–85 years; 2) Meets DSM-5 criteria for major depressive episode; 3) Received adequate, full-course treatment with two or more antidepressants as prescribed without significant improvement; 4) Moderate or severe depression: Montgomery-Åsberg Depression Rating Scale (MADRS) score >20; 5) Sleep disturbance: Pittsburgh Sleep Quality Index (PSQI) score >=8; 6) Received rapid antidepressant treatment with esketamine combined with self-administered sleep therapy using dexmedetomidine; 7) Investigator's assessment that the subject is willing and able to comply with scheduled visits, treatment protocols, and follow-up requirements during the study period; 8) Willingness to sign a written informed consent form.
Exclusion criteria
Exclusion criteria: 1.The following conditions disqualify a subject from inclusion: 1) New York Heart Association (NYHA) functional class > III, renal insufficiency (serum creatinine > 177 µmol/L), or malignant neoplasms; 2) DSM-5 criteria for delirium, bipolar disorder, schizophrenia, schizophreniform disorder, affective disorder, mental retardation, or pervasive developmental disorder; 3) Known allergy to dexmedetomidine or ketamine, or concurrent use of medications known to interact with dexmedetomidine or ketamine; 4) Presence of sleep apnea syndrome (see Appendix 1) or restless legs syndrome, either pre-existing or identified during sleep titration; 5) Presence of sick sinus syndrome, severe sinus bradycardia (heart rate <50 beats/min), or second-degree or higher atrioventricular block without pacemaker implantation; 6) Severe hepatic impairment (Child-Pugh Class C) or patients with an expected survival <=24 hours; 7) Inability or refusal of the subject or legal guardian to sign the informed consent form.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Montgomery scale, MADRS;Pittsburgh Sleep Quality Index questionnaire, PSQI; | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of suicidal ideation, BSI-CV;Hamilton rating scale, HAMA; | — |
Countries
China
Contacts
Public ContactJianxiong An
Southern Medical University Hospital of Integrated Traditional Chinese and Western Medicine
Outcome results
None listed