Post-stroke depression
Conditions
Interventions
Control Group:Oral paroxetine
Treatment group:Acupuncture
Sponsors
Gansu Provincial Hospital of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
40 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Imaging (CT or MRI) confirms the diagnosis of ischemic or hemorrhagic stroke, with the condition in a relatively stable phase, and the time from onset to enrollment between 2 weeks and 12 months; 2. Baseline depression severity meets the diagnostic threshold for post-stroke depression, i.e., a total score of =17 on the HAMD-17 scale; age between 40 and 80 years, with basic educational attainment and communication ability, capable of understanding the questionnaire content and completing the assessment; 3. At least 14 days prior to enrollment, no antidepressants, antipsychotics, or systemic psychotherapy (for drugs with a longer half-life, the discontinuation period must be at least 5 half-lives), and no acupuncture or other traditional Chinese medicine external treatments for at least 4 weeks; comorbid hypertension, diabetes, and other chronic diseases are stably controlled for =3 months; 4. The subject or their legal representative voluntarily signs the informed consent form and is expected to complete all interventions and follow-ups over a 6-month period.
Exclusion criteria
Exclusion criteria: 1. Presence of suicidal ideation, or severe depression requiring hospitalization/electroconvulsive therapy; comorbid bipolar disorder, schizophrenia spectrum disorder, or substance dependence within the past 6 months; 2. Severe aphasia or significant cognitive impairment (MMSE < 20) rendering scale assessment impossible; 3. History of allergy to paroxetine or other SSRIs, or clear contraindications to their use; 4. Use of monoamine oxidase inhibitors (MAOIs) within 14 days prior to enrollment; 5. Comorbid narrow-angle glaucoma, moderate to severe hyponatremia, pregnancy, or lactation; 6. High risk of bleeding (e.g., history of severe bleeding, significant coagulation disorders) or other contraindications to acupuncture; 7. Severe cardiovascular, hepatic, renal, or hematological diseases; plans to receive other antidepressant medications, systemic psychotherapy, or traditional Chinese medicine external treatments during the trial, or concurrent participation in other clinical trials; 8. Inability to provide valid informed consent or deemed unsuitable for participation in this study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hamilton Depression Rating Scale;Activities of Daily Living (ADL) Assessment;Neurological Deficit Assessment; | — |
Secondary
| Measure | Time frame |
|---|---|
| 5-hydroxytryptamine;dopamine;Norepinephrine;Interleukin-6;Tumor Necrosis Factor; | — |
Countries
China
Contacts
Public ContactLiu Liting
Gansu Provincial Hospital of Traditional Chinese Medicine
Outcome results
None listed