Sleep disorders accompanied by depression
Conditions
Interventions
The group below the treatment concentration, the group within the treatment window concentration, and the group above the treatment window concentration:Citalopram plasma concentration
Sponsors
Shanghai General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.It meets the criteria for sleep disorders (PSQI>= 10 points) and is accompanied by depressive symptoms (HAMD>7 points). 2.Age >= 18 years old, gender not limited. 3.After using citalopram tablets for >= 12 weeks, complete medication information (dosage, blood drug concentration, adjustment time, and concurrent medication) can be extracted. 4.After medication, the scores of the Sleep Quality Index (PSQI) and the Depression Scale (HAMD), as well as the electrocardiogram indicators, should be evaluated at least twice (at 4 weeks, 8 weeks, and 12 weeks), with an interval of no more than 7 days between the scores and the TDM test.
Exclusion criteria
Exclusion criteria: 1.Combined with severe physical diseases (such as heart failure, abnormal liver and kidney functions); 2.Suffering from prolonged QT interval or congenital QT syndrome; 3.Other mental disorders (bipolar disorder, schizophrenia) or a history of substance abuse; 4.Pregnant or lactating women, or those planning to become pregnant; 5.The use of other SSRI drugs, monoamine oxidase inhibitors or the risk of drug interactions during the medication period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of QTc Interval Prolongation = 50% improvement in the Pittsburgh Sleep Quality Index (PSQI) score after 12 weeks of treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Situation of HAMD Score Decrease >= 50%;The degree of improvement in the Pittsburgh Sleep Quality Index; | — |
Countries
China
Contacts
Public ContactYuanjun Tang
Shanghai General Hospital
Outcome results
None listed