treatment-resistant depression
Conditions
Interventions
Multi-modal Magnetic Seizure Therapy Group:None
Sponsors
Integrated Chinese and Western Medicine Hospital of Southern Medical University
Eligibility
Sex/Gender
All
Age
60 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Aged 60-85 years; 2. Meets DSM-5 criteria for a major depressive episode; 3. Has shown no significant therapeutic response after at least two consecutive adequate trials of antidepressants with different mechanisms of action (at 75%-100% of the recommended dose for each medication) for a sufficient duration (>=8 weeks) with adherence to medical advice; 4. Moderate to severe depression: Montgomery-Åsberg Depression Rating Scale (MADRS) score >20; 5. Sleep disorder: Pittsburgh Sleep Quality Index (PSQI) score >=8; 6. Receiving multi-modal magnetic seizure therapy for rapid antidepressant effects; 7. The investigator considers the subject willing and able to comply with scheduled visits, the treatment plan, and complete follow-up requirements during the study period; 8. Agrees to provide written informed consent.
Exclusion criteria
Exclusion criteria: 1. Cardiac function class (NYHA) > III, serum creatinine > 177 µmol/L, and malignant tumor; 2. Severe hepatic dysfunction (Child-Pugh Class C) or expected survival =6 months); uncontrolled alcohol use disorder (with a history of binge drinking within the past 3 months or an AUDIT-C score >=4) or substance use disorder (excluding nicotine dependence). 4. Difficult airway; 5. Unable to communicate due to coma, severe dementia, or language impairment; 6. Subjects with known allergy to dexmedetomidine or ketamine, or taking medications that may interact with dexmedetomidine or ketamine; 7. Presence of or discovery during sleep titration of sleep apnea syndrome or restless legs syndrome; 8. Sick sinus syndrome, severe sinus bradycardia (heart rate <50 beats/min), or second-degree or higher atrioventricular block without pacemaker implantation; 9. Subjects or their legally authorized representatives who are unable or unwilling to sign informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Montgomery-?sberg Depression Rating Scale, MADRS;Pittsburgh Sleep Quality Index, PSQI; | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of ultra magnetic seizure therapy stimulations and seizure wave onset time per stimulation;Life signs (blood pressure, heart rate, breathing);Beck Scale for Suicide Ideation-Chinese Version, BSI-CV;Mini-Mental State Examination, MMSE;Montreal Cognitive Assessment, MoCA;Hamilton Anxiety Scale, HAMA; | — |
Countries
China
Contacts
Public ContactAn Jianxiong
Integrated Chinese and Western Medicine Hospital of Southern Medical University
Outcome results
None listed