Mild to moderate depression with insomnia
Conditions
Interventions
Experimental group:Sleep hygiene health education + Escitalopram 10~20mg+ Zaleplon 10mg, qd, intervention for 4 weeks
Control group:Sleep health education + Escitalopram 10~20mg, qd, intervention for 4 weeks
Sponsors
First Hospital of Shanxi Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Age 18~60 years old, male or female, outpatient; 2. Meet the DSM-5 diagnostic criteria for depressive disorders, and score 8=3 times/week), Pittsburgh Sleep Quality Index (PSQI) >=11 points; Insomnia Severity Index Scale (ISI) >=7 points; 4. No standardized and continuous use of antidepressants and/or sedative-hypnotic drugs for more than 1 week in the past month; 5. Communication barrier-free, can cooperate with the completion of relevant scales and inspections; 6. Laboratory (blood routine, liver function, kidney function) examination, vital signs, and 12-lead electrocardiogram in the past 3 months showed no abnormalities; 7. The patient and his/her family members or guardians sign a written informed consent form.
Exclusion criteria
Exclusion criteria: 1. Those with severe suicidal tendencies (HAMD item 3 "suicide" >=3 points); 2. Patients who wake up easily or early at night for > = 3 days per week; 3. Patients with other psychiatric diseases or secondary insomnia, such as insomnia disorders that occur after using certain drugs or on the basis of organic encephalopathy or serious physical diseases; 4. Presence of obstructive sleep apnea or restless legs syndrome, rapid eye movement sleep behavior disorder, hypersomnolence disorder, and any disease state that may affect the results of the study; 5. Insomnia related to circadian rhythm disorders within 14 days, such as at night, working in shifts or with a time zone of more than 3 hours; 6. Patients with serious or unstable heart, liver, kidney, endocrine, hematological and other internal diseases and malignant tumors; 7. Patients with severe dyspnea or chest disease, myasthenia gravis; 8. Patients with known QT prolongation or congenital QT syndrome; 9. Those with a history of epilepsy (except for febrile seizures in children); 10. Those who have a history of abuse or dependence on alcohol or psychoactive substances within 1 year prior to screening (except for caffeine or nicotine dependence); 11. Those who have received electroconvulsive therapy within 30 days before screening; 12. Those who started or discontinued receiving systematic individualized psychotherapy within 6 weeks before screening; 13. Women of childbearing age who are lactating, pregnant, have a positive pregnancy test at screening, or are likely to become pregnant during the trial; 14. Patients who are allergic to zaleplon or escitalopram components or have other contraindications in the instructions; 15. Those who have received other clinical trial drugs within 30 days or are participating in other clinical trials; 16. Those who are judged by the investigator to be unable to take medication according to the doctor's instructions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Insomnia Severity Index;Pittsburgh Sleep Quality Index; | — |
Secondary
| Measure | Time frame |
|---|---|
| Polysomnography;Hamilton Depression Rating Scale;Hamilton Anxiety Rating Scale;Daytime function;Fatigue Severity Scale;Morningness-Eveningness Questionnaire;UKU Side Effects Scale; | — |
Countries
China
Contacts
Public ContactLiu Zhifen; Li Xinrong
First Hospital of Shanxi Medical University
Outcome results
None listed