Depression Related Insomnia
Conditions
Interventions
control group:Fluoxetone(trade name: Prozac 20mg/tablet Lilly Suzhou Pharmaceutical Approval numberJ20130010)was adminsrtatered orally once a day with 20mg each time for 8 weeks before treatment. Zhen
treatment group:Fluoxetone(trade name: Prozac 20mg/tablet Lilly Suzhou Pharmaceutical Approval numberJ20130010)was adminsrtatered orally once a day with 20mg each time for 8 weeks before treatment. Zh
Sponsors
Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1)Age 18-65 years old, gender unlimited; (2)Insomnia as the main complaint, in line with the DSM-V insomnia dignosis article 1-7; (3)It met the diagnostic criteria of the international classification dieases(ICD-10) for mild to moderate depression, and scored 27 points on the Hamilton Depression Scale(17-item edition), and =24 points. (4)In line with the TCM diagnostic criteria of insomnia and depression, and in line with the diagnostic criteria of heart-gallbladder qi deficiency syndrome diagonsis criteria; (5)The cumulative score of 7 factors of Pittsburgh Sleep Quality Index Scale(PSQI) was >7 points; (6)Voluntary participation and signed informed consent.
Exclusion criteria
Exclusion criteria: (1)Secondary insomnia,environmental sleep disorders, etc. obstructive sleep apnea-hypopnea syndrome; depression caused by depression secondary to other mental and physical dieases. (2)Patients with serious primary heart, liver, lungs, kidneys, blood or serious diseases affecting their survival, mental illness or serious suicidal tendencies. (3)Screening for alcohol dependence and drug abuse within the perivous year; (4)Pregnant and lactating women; (5)Participants who participated or participating in other drug clinical trials in the 3 months prior to enrollment; (6)Patients with other conditions deemed by the investigator to be ineligible for screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| REM sleep latency;REM sleep time;REM sleep density; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pittsburgh Sleep Quality Index Scale;TCM syndrome grading quantified intergral;Hamilton Depression Scale;sleep latency;sleep time;sleep efficiency;wake time after sleep onset;NREM1 sleep as a percentage of total sleep time;NREM3 sleep as a percentage of total sleep time; | — |
Countries
China
Contacts
Public ContactQing Ye
Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Outcome results
None listed