ITMCTR2100004821
Recruiting
Phase 4
Efficacy and safety of Wuling capsule in the treatment of early Parkinson's disease with mild depression: a multicenter, randomized, double-blind, placebo-controlled study
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Xinhua Hospital, Affiliated to Shanghai Jiaotong University, School of Medicine
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Patients aged 45 to 80 years with primary Parkinson's disease, regardless of gender;
- •2\.Hoehn\-Yahr grading \< 3 at the onstage;
- •3\.MMSE \>\= 24 points;
- •4\.Accompanied with depressive symptoms (8 \<\= HAMD17 \< 18\);
- •5\.Stable basic treatment for Parkinson's disease;
- •6\.Sign informed consent.
Exclusion Criteria
- •1\.Other nervous system diseases, mental diseases and serious physical diseases;
- •2\.History of alcohol and drug dependence;
- •3\.Dementia patients;
- •4\.High risk of suicide or suicide attempt within 6 months (HAMD\-17 item 3 \>\= 3 points);
- •5\.Antidepressant treatment or other psychotic treatment in the past month;
- •7\.Those who participated in other clinical trials in recent 3 months;
- •8\.Pregnant or lactating women;
- •9\.Patients considered unsuitable for the study.
Outcomes
Primary Outcomes
Not specified
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