Post-sroke depression, PSD
Conditions
Interventions
Toludesvenlafaxine Hydrochloride Sustained-release Tablets :Method of administration for Torudivranfaxine Hydrochloride Sustained Release Tablets:
It should be taken at a relatively fixed time every
Sponsors
Tongji Medical College of HUST
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Age range from 18 to 75 years (including boundary values), regardless of gender; (2) Confirmed as ischemic stroke by electronic computed tomography (CT) or magnetic resonance imaging (MRI) and diagnosed to date for = 1 year; (3) Those who meet the diagnostic criteria for PSD and have a HAMD-17 score of = 18 can be diagnosed as PSD. Refer to DSM-V's diagnostic standards for PSD, as follows: A. The main clinical manifestation is a prominent persistent depressive mood, or a significant decrease in interest or pleasure in all or almost all activities. B. Evidence from medical history, physical examination, or laboratory findings suggests that this disorder is a direct pathological and physiological result of other physical diseases. C. This disorder cannot be better explained by other mental disorders. D. This disorder does not only occur during delirium. E. This disorder causes clinically significant pain or leads to damage in social, occupational, or other important functional aspects. (4) Having clear consciousness, no serious intellectual impairment, able to express language independently, and without obvious symptoms of dementia; (5) The subjects voluntarily participated in this experiment and signed an informed consent form.
Exclusion criteria
Exclusion criteria: (1) PSD accompanied by mental symptoms or severe self injury, suicidal ideation or behavior [HAMD-17 item 3 (suicide) = 3 points)]; (2) Have taken any antidepressant medication within 2 weeks prior to enrollment; (3) Individuals with allergic constitution or known allergies to venlafaxine or norvenlafaxine; (4) Speech difficulties or aphasia; (5) Individuals who are unable to complete the examination due to visual, auditory, and cognitive impairments (MMSE1.5 times the upper limit of normal value; Thyroid stimulating hormone (TSH) exceeds the normal range; (12) Abnormal electrocardiogram (ECG) during screening has clinical significance, such as QTc interval>470 ms in males and>480 ms in females; (13) At the time of screening, it was in the acute phase of infection (WBC>11 × 109/L); (14) Breastfeeding women or those who cannot guarantee effective contraceptive measures during the study period; (15) Other situations where researchers believe patients are not suitable for clinical research.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hamilton Depression Scale, HAMD; | — |
Secondary
| Measure | Time frame |
|---|---|
| National Institute of Health stroke scale,NIHSS;Dimensional Anhedonia Rating Scale, DARS;Barthel Index, BI;Modified Rankin Scale,mRS;Sheehan Disability Scale, SDS;Mini-mental State Examination,MMSE;Apathy evaluation scale-clinical,AES-C; | — |
Countries
China
Contacts
Public ContactZhu Suiqiang
Department of Neurology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed