Effectiveness and Safety of Dexmedetomidine and... — Clinical Trial Details

Effectiveness and Safety of Dexmedetomidine and Esketamine Combined Infusion on Difficult-to-Treat Depression with Comorbid Insomnia: A Multicenter, Prospective, observational Real-World Study

This multicentre, prospective observational cohort study (n=45) in China is assessing the effectiveness and safety of dexmedetomidine and esketamine combined infusion in older adults with difficult-to-treat depression and comorbid insomnia. The study enrols both men and women aged 60 to 85 years, with treatment-resistant depression and insomnia. As an observational real-world study, it does not include an intervention group with randomised allocation or a comparator arm; rather, it follows patients receiving clinical care in routine practice. Primary outcomes are the Montgomery–Åsberg Depression Rating Scale (MADRS) and the Pittsburgh Sleep Quality Index (PSQI), indicating that the trial is focusing on changes in depressive symptoms and sleep quality. Secondary assessments include suicidal ideation measured by the BSI-CV and anxiety symptoms measured by the Hamilton Anxiety Rating Scale (HAMA). No formal phase is specified. Overall, this study is designed to provide real-world evidence on whether combined dexmedetomidine and esketamine infusion may be a useful and safe approach for older patients with persistent depression and insomnia in a Chinese clinical setting.

Participants

Ages

60 – 85

Sexes

Male & Female

BMI

Psychosis History

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.

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Effectiveness and Safety of Dexmedetomidine and Esketamine Combined Infusion on Difficult-to-Treat Depression with Comorbid Insomnia: A Multicenter, Prospective, observational Real-World Study

Participants

Inclusion Criteria

Exclusion Criteria

Locations

Study Details