chronic insomnia and depression
Conditions
Interventions
Group 1:placebo pill
Group 2:Agomelatine pill
Group 3:Zolpidem Tartrate pill
Sponsors
Changzheng Hospital of Second Miliatary Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Meet the diagnostic criteria for chronic insomnia accordingto ICSD-3; 2. Becks depression score 10-25; 3. Aged 18-75 years; 4. Agree to participate in clinical study and sign of informed consent; 5. Have and know how to use smart terminals, such as mobile phones, tablets, etc.
Exclusion criteria
Exclusion criteria: 1) Potential allergy to the test drugs and its components; 2) Severe depression (Becks score>25), or with suicidal will or behavior; 3) Liver injury, including abnormal liver function, hepatitis b, hepatitis c/carriers; 4) Potential liver injury risk factors, such as obesity/overweight/nonalcoholic fatty liver disease, diabetes, excessive drinking, or are taking drugs may cause liver damage and so on; 5) Combined other important organs diseases such as heart, kidney, hematopoietic system disease, Cr more than normal ceiling; 6) cancer or have suffered; 7) pregnancy, lactation, prepare pregnancy; 8) oral estrogen contraception; 9) Using ciprofloxacin, rifampicin, smoking, drinking alcohol; 10) Using sedative hypnotic drugs within 7 days; 11) Using the following drugs within 3 weeks: monoamine oxidase inhibitors such as Phenethylhydrazine and Phenylpropanolamine, etc.; Tricyclic antidepressants: Imipramine, chlorimipramine, protiline, etc.; Selective serotonin reuptake inhibitors such as fluvoxamine, citalopram; Norepinephrine and serotonin reuptake inhibitors such as Venlafaxine, Duloxetine, etc; Selective norepinephrine reuptake inhibitors such as Ribositin, Verushaazine, Atoxetine, etc.; 12) Combined other medicine, nerve, mental diseases, including the abnormal thyroid function, schizophrenia, dementia, Parkinson's, etc.; 13) Combined other sleep disorders; 14) Shift worker, perennial night-shift workers, frequent flying across time zones, such as international flight crew staff); 15) Participated in other clinical subjects within three months; 16) Researchers think not appropriate for the clinical subjects.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PSG;Gauge;Intelligent hand ring;Immunological marker;Melatonin;Routine blood test;Function of liver and kidney;hepatitis B;HCV;thyroid function;Antithyroglobulin antibody;Urine HCG;EKG; | — |
Countries
China
Contacts
Public ContactHuijuan Wu
Changzheng Hospital of Second Miliatary Medical University
Outcome results
None listed