Post-stroke Depression
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1) Meet the diagnostic criteria for moderate post-stroke depression according to Western medicine and for the liver depression and spleen deficiency syndrome according to Traditional Chinese Medicine (TCM) pattern differentiation. (2) Hamilton Depression Scale (HAMD-17) score: >17 and 17 for illiterate individuals, >20 for those with primary school education, and >24 for those with junior high school education or above, indicating clear consciousness and ability to cooperate with tests and examinations. (4) Age between 18 and 75 years. (5) No use of other antipsychotic or antidepressant medications within the 2 weeks prior to enrollment. (6) Voluntary participation with signed informed consent provided by the patient.
Exclusion criteria
Exclusion criteria: (1) Diagnosed with intracerebral hemorrhage, subarachnoid hemorrhage, or epilepsy; (2) Pre-stroke diagnosis or medical history suggesting a clearly existing depressive state; (3) Co-existing other psychiatric disorders, such as mania, schizophrenia, etc.; (4) Having severe suicidal tendencies (score on the suicide item of HAMD-17 > 2); (5) Presence of speech disorder, consciousness disorder, intellectual disability, or other conditions preventing cooperation with examinations; (6) Women who are pregnant or lactating; (7) Participation in another clinical drug study within the past month; (8) History of allergy to the study drug(s).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hamilton depression scale; | — |
Secondary
| Measure | Time frame |
|---|---|
| Montgomery-Asberg Depression Rating Scale;Syndrome score of depression in traditional Chinese medicine;National Institutes of Health Stroke Scale;Barthel index score;Resting-state functional magnetic resonance imaging;IL33;CX3CL1; | — |
Countries
China
Contacts
Shanghai 7th People's Hospital