Post-stroke depression.
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion criteria for case selection: 1. Diagnostic criteria for stroke: Diagnosed by cranial CT or MRI in accordance with the "Diagnostic Guidelines for Various Types of Cerebrovascular Diseases in China"[1]. 2. Diagnostic criteria for post-stroke depression (PSD): a. Western medicine diagnostic criteria: Refer to the "Chinese Clinical Practice Guidelines for Post-Stroke Depression"[2] for diagnostic criteria. Clinical manifestations include symptoms such as low mood pessimism psychomotor retardation reduced interest irritability fatigue and slow thinking. b. Traditional Chinese medicine (TCM) diagnostic and syndrome differentiation criteria: Based on the 5th edition of "TCM Internal Science" and "Diagnostic and Therapeutic Criteria for TCM Diseases and Symptoms" the following diagnostic criteria are established: i. Occurs after stroke caused by emotional discomfort and stagnation of Qi. ii. Symptoms such as melancholy low spirits chest and rib-side distension or abdominal (a type of discomfort in TCM) frequent belching frequent sighing and menstrual irregularities in women. iii. A history of emotional stress with symptoms such as depression overthinking sadness and sorrow. iv. Exclusion of organic diseases through systemic examinations and laboratory tests. 3. Case inclusion criteria: a. Meet the above diagnostic criteria. b. Underlying diseases are well-controlled with symptoms and severity criteria lasting for at least 2 weeks and the course of stroke within 1 year. c. The patient's 24-item Hamilton Depression Scale score is =9. d. No history of depressive disorder or use of antidepressant medication. e. The patient and family provide informed consent for this study and have signed the informed consent form. f.Both men and women are applicable.
Exclusion criteria
Exclusion criteria: Exclusion criteria for patients: 1. Patients with a history of dementia or neurological diseases that affect cognitive function. 2. Patients with visual impairments or communication difficulties. 3. Patients with severe organ failure or dysfunction. 4. Patients with severe physical illnesses such as malignant tumors that may significantly impact the study results. 5. Patients with mental disorders that prevent them from providing medical history and cooperating with the study. 6. Patients with a history of allergy to the medications used in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 24-item Hamilton Depression Rating Scale (HAMD) score;Diffusion Tensor Imaging (DTI) metrics measurement;Magnetic Resonance Spectroscopy (MRS) measurement; | — |
Secondary
| Measure | Time frame |
|---|---|
| Serum ELISA;Rating Scale for Side Effects;Fractional Anisotropy;BDNF DNA methylation;Barthel Index;National Institutes of Health Stroke Scale (NIHSS) score; | — |
Countries
China
Contacts
"The Sixth Department of Brain Diseases The Second Affiliated Hospital of Anhui University of Chinese Medicine"