Post-stroke depression
Conditions
Interventions
PSD group(Intervention group):Patients took Shugan Jieyu Capsules orally (2 capsules per dose, twice a day) for a duration of 12 weeks. At the same time, all patients received standard secondary strok
Sponsors
Guangdong Provincial Hospital of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: PSD administration group: 1.18 = age = 80 years old; 2. Diagnosed with ischemic stroke within the past 1 year, confirmed by brain MRI or CT; 3.Meeting DSM-5 diagnostic criteria for depressive disorder due to another medical condition (stroke), with symptoms lasting = 2 weeks; 4.7 < Hamilton Depression Rating Scale (HAMD-17) score < 24; 5.Able to cooperate with follow-up; 6.Signed the informed consent form. Healthy Volunteer Group: 1. Age between 18 and 80 years; 2. HAMD-17 score < 7; 3. Body Mass Index (BMI) between 19.0 - 26.0 kg/m²; 4. No abnormalities found in physical examination, vital signs, laboratory tests, ECG, etc.; 5. Able to cooperate with follow-up; 6. Signed informed consent form.
Exclusion criteria
Exclusion criteria: PSD administration group: 1.History of clearly diagnosed primary psychiatric disorders, such as schizophrenia spectrum and other psychotic disorders (e.g., schizophrenia, schizoaffective disorder, brief psychotic disorder), bipolar and related disorders (e.g., bipolar I disorder, bipolar II disorder), obsessive-compulsive disorder, or post-traumatic stress disorder (previous episodes unrelated to the current stroke); 2.Brain dysfunction caused by non-vascular reasons, such as brain dysfunction caused by primary brain tumors, brain metastases, subdural hematomas, impaired consciousness following epileptic seizures, or brain trauma; 3.A history of depression prior to the stroke; 4.Severe suicidal ideation or behavior; 5.A personal or family history of epilepsy; 6.Patients who have used antidepressants, received electroconvulsive therapy or repetitive transcranial magnetic stimulation therapy within 2 weeks before enrollment; 7.Unable to cooperate with follow-up due to intellectual disability, severe dementia (MMSE score = 9), aphasia, impaired consciousness, etc.; 8.Those with moderate-to-severe disability, scoring = 4 on the modified Rankin Scale (mRS) during the screening period; 9.Severe hepatic or renal insufficiency: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.0 times the upper limit of normal, and/or other known liver diseases such as acute or chronic hepatitis, cirrhosis; serum creatinine > 2.0 × ULN, and/or known severe renal insufficiency; 10.Other life-threatening severe diseases, such as malignant tumors, severe diseases of the blood, digestive system, or other systems, with an expected survival time of less than 3 months; 11.Pregnant, planning to become pregnant or lactating women; 12.Known allergy to Shugan Jieyu Capsules or their ingredients (Eleutherococcus senticosus, Hypericum perforatum L./St. John’s wort), or a history of severe allergies; 13.Those with a history of or suspected history of alcohol or drug abuse; 14.Those who have participated in other clinical trials within 3 months before enrollment, or are currently participating in other clinical trials; 15.Other conditions judged by the investigator as unsuitable for participation in this study. Healthy Volunteer Group: 1. History of clearly diagnosed primary psychiatric disorders, such as: schizophrenia spectrum and other psychotic disorders (e.g., schizophrenia, schizoaffective disorder, brief psychotic disorder), bipolar and related disorders (e.g., bipolar I disorder, bipolar II disorder), obsessive-compulsive disorder, post-traumatic stress disorder (previous episodes unrelated to the current stroke); 2. Brain dysfunction caused by non-vascular reasons: such as primary brain tumors, brain metastases, subdural hematomas, post-seizure consciousness disorders, brain injury, etc.; 3. History of depression before stroke; 4. Severe suicidal ideation or behavior; 5. History of epilepsy or family history of epilepsy; 6. Use of antidepressant medication, or received electroconvulsive therapy or repeated transcranial magnetic stimulation within 2 weeks before enrollment; 7. Intellectual disability, severe dementia (MMSE
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in the Hamilton Depression Rating Scale (HAMD-17) score after 12 weeks of treatment.;Changes in mRS, HAMA, PSQI, MoCA, MMSE, SSS, FSS, ESS, and MAES scores; | — |
Countries
China
Contacts
Public ContactZiyi Zhou
Guangdong Provincial Hospital of Chinese Medicine
Outcome results
None listed