Vascular depression
Conditions
Interventions
Combined therapy group:Escitalopram 10mg once daily, plus tandospirone citrate 5mg 3 times a day for the first week, increased to 10mg 3 times a day from the second week.
Monotherapy group:In the monotherapy group, Escitalopram 10mg, once a day, plus a placebo preparation with the same size, shape and smell as tandospirone citrate 5mg, 3 times a day in the first week,
Healthy control group:No drugs that may affect 5-HT metabolism, and only preventive treatment of common diseases in the elderly.
Sponsors
Fujian Medical University Union Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Study group inclusion criteria: (1) meet the diagnostic criteria for first or recurrence of depression in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) of the American Psychiatric Association; (2) Meet the diagnostic criteria for vascular depression recommended by Alexopoulos et al. (3) Hamilton depression rating scale (HAMD) > 17 points; (4) It requires clear consciousness, self-care ability, and the ability to basically complete the evaluation of various scales independently. (5) The diagnostic criteria for sleep disorders in the International Classification of Sleep Disorders, Third Edition (ICSD-3) must be met. Health control inclusion criteria: Selected the same period of outpatient health check-up patients matching the baseline data such as gender, age and education as the control group, who must meet the following conditions: (1) age =50 years old; (2) no complaints of sleep disorders; (3) No evidence of objective cognitive dysfunction: MMSE score =27 points, MoCA score =26 points (MoCA score plus 1 point for subjects with less than 12 years of education), ADL < 24 points; (4) Can cooperate with the completion of relevant inspections.
Exclusion criteria
Exclusion criteria: (1) Previous or current patients with other psychiatric diseases other than depression and anxiety; (2) epilepsy, Alzheimer's disease, Parkinson's disease, intracranial tumors and other neurological diseases; (3) accompanied by serious or unstable heart, liver, kidney, endocrine, blood, respiratory and other internal diseases; (4) Patients allergic to escitalopram and tandospirone citrate; (5) Suicide Assessment Scale (SUAS) rated as high risk of suicide (score > 30); (6) Alcohol Dependence Screening Scale (MAST) confirms alcohol or drug dependence (score =5); (7) Poor medication compliance was assessed by medication Compliance Scale-8 (MMAS-8) (score < 6); (8) Can not cooperate with the completion of head MRI examination; (9) Have participated in other clinical studies within the last 30 days.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| polysomnography (PSG) parameters;Neuropsychological assessment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Epworth sleepiness score;Platelet 5-HT level;Plasma 5-HT level;Pittsburgh Sleep Quality Index scale;Asen Insomnia Self-rating Scale;Platelet serotonin receptor levels; | — |
Countries
China
Contacts
Public ContactYingchun Xiao
Fujian Medical University Union Hospital
Outcome results
None listed