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

Phase 4

Recruiting

• Conditions: Parkinson's disease

• Registration Number: ITMCTR2100004821
• Lead Sponsor: Xinhua Hospital, Affiliated to Shanghai Jiaotong University, School of Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
the change of Hamilton depression scale during the treatment;

Secondary Outcome Measures

Name	Time	Method
Pittsburgh Sleep Scale;the change of Hamilton Anxiety Rating Scale during the treatment;the change of clinical global impression scale during the treatment;