late-life depressive disorder, Alzheimer’s disease dementia, schizophrenia, bipolar disorder
Conditions
Interventions
Lemborexant Treatment Group:NA
Sponsors
Huilongguan Hospital Affiliated to Capital Medical University
Eligibility
Sex/Gender
All
Age
60 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. The patient is able to understand and comply with the study procedures, and voluntarily signs the informed consent form for the study. 2. Aged >= 60 years old (based on the baseline date), with no gender restrictions. 3. Meets the diagnostic criteria for depressive disorders, bipolar and related disorders, or schizophrenia as specified in the Diagnostic and Statistical Manual of Mental Disorders (5th Edition) (DSM-5), or meets the diagnostic criteria for Alzheimer’s disease (AD); and has no plan to change the currently administered antidepressants, mood stabilizers, antipsychotics, or cognitive-improving drugs within 1 month prior to enrollment. 4. Meets the DSM-5 diagnostic criteria for insomnia, with symptoms occurring at least 3 times per week and persisting for at least 1 month. 5. Scores >= 15 points on the Insomnia Severity Index (ISI). 6. Assessed by a physician as suitable for lemborexant treatment and has been issued a corresponding prescription.
Exclusion criteria
Exclusion criteria: 1. Patients judged by the investigator to be unable to cooperate with completing scale assessments due to cognitive impairment. 2. Patients with current severe or unstable cardiovascular, hepatic, renal, hematological, endocrine, neurological, or other systemic and organ diseases. 3. Presence of other sleep disorders besides insomnia, such as narcolepsy, restless legs syndrome, etc. 4. Having used DORAs (lemborexant, daridorexant) for the current episode of illness. 5. Patients with current suicidal risk; or those with a score of = 3 on Item 3 (suicidal item) of the 17-item Hamilton Depression Scale (HAMD-17). 6. Currently taking, or planning to take during the study period, strong or moderate CYP3A4 inducers/inhibitors (see Appendix 1 for the specific list of drugs). 7. Having participated in any interventional clinical trial involving drugs or medical devices within 3 months prior to enrollment. 8. Presence of contraindications to lemborexant use, or hypersensitivity to lemborexant. 9. Presence of any physical or mental diseases or conditions that the investigator deems may increase trial risks, affect the patient’s compliance with the protocol, or prevent the patient from completing the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Insomnia Severity Index,ISI; | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical global improvement,CGI;Hamilton Anxiety Rating Scale (HAMA);Repeatable Battery for the Assessment of Neuropsychological Status,RBANS;Hamilton Depression Rating Scale;Minimum Mental State Examination;Adverse Event (AE);The Epworth Sleepiness Scale,ESS;fatigue severity scale,FSS;Pittsburgh sleep quality index,PSQI; | — |
Countries
China
Contacts
Public ContactYang Fude
Huilongguan Hospital Affiliated to Capital Medical University
Outcome results
None listed