Parkinson’s disease with depression
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Meets the diagnostic criteria for Parkinson’s disease dementia (PDD); 2. Age 40–80 years, either sex; 3. Hoehn–Yahr stage 1–3 for Parkinson’s disease; 4. Montgomery–Åsberg Depression Rating Scale (MADRS) score of 7–34 (mild to moderate depression); 5. Has been receiving anti-Parkinsonian medication for at least 6 months, with stable dosage for at least 1 month prior to enrollment; 6. Has not participated in any other drug, acupuncture, or clinical trial interventions within the past month prior to enrollment; 7. Vital signs are stable, with no impairment of consciousness, and able to communicate normally and complete all assessments; 8. Voluntarily participates in the study and provides written informed consent.
Exclusion criteria
Exclusion criteria: 1. Other psychiatric or neurological diseases that significantly affect depression assessment, such as schizophrenia, bipolar disorder, dementia, cerebrovascular disease, etc.; 2. Secondary Parkinson's syndrome or Parkinson's plus syndrome; 3. Start, stop, or adjust the use or dosage of antidepressants within 1 month prior to enrollment; 4. Have received or are receiving other systemic treatments for depression within 1 month before screening, such as other types of acupuncture, repetitive transcranial magnetic stimulation (rTMS), systemic psychotherapy, etc.; 5. Complicated with serious systemic diseases (such as serious cardiovascular disease, liver and kidney failure, malignant tumor, etc.), which may affect the safety or compliance of treatment; 6. Have a serious risk of suicide or a recent history of suicidal behavior; 7. Pregnant or lactating women, or those planning to become pregnant during the trial; 8. Contraindications to acupuncture treatment, such as severe fear, history of acupuncture syncope, severe bleeding tendency, skin infection at the treatment site, or severe arrhythmia; 9. Unable to understand the study procedures or unable to cooperate with scale assessments and follow-up.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Montgomery-Asberg Depression Rating Scale; | — |
Secondary
| Measure | Time frame |
|---|---|
| Hospital anxiety and depression scale;The motor part of the Unified Parkinson's Disease Rating Scale;Parkinson‘s Disease Questionnaire - 8;Pittsburgh sleep quality index;Clinical Global Impression Scale;Caregiver Burden Scale;The Acupuncture Expectancy Scale;Columbia Suicide Severity Scale;Laboratory markers: IL-6, TNF-a, hs-CRP, BDNF, and KYN/TRP ratio.; | — |
Countries
China
Contacts
The First Affiliated Hospital of Guangzhou University of Chinese Medicine