The Profile of the Depression and it's Intervention Strategy in Patients With Parkinson's Disease in China

Parkinson Disease Clinical Trial

Official title:

The Profile of the Depression and it's Intervention Strategy in Patients With Parkinson's Disease in China

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03026595
• Other study ID #: XH-16-047
• Status: Recruiting
• Start date: January 2017
• Est. completion date: December 2018

Study information

• Verified date: May 2018
• Source: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Contact: Mingzhu Zhou
• Phone: 15021628699
• Email: estherzhoumz[@]aliyun.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Depression is considered to be the most common neuropsychiatric disturbance of PD. In this study, investigators will summarize the treatment profile of PD depression to see if PD depression is properly treated according to guideline.

Description:

Depression is considered to be the most common neuropsychiatric disturbance of PD. Prevalence rates of depressive disorders in Parkinson's disease(PD) vary widely across studies, ranging from 2.7% to more than 90%. A systematic review of the 36 articles concerning PD and depression indicates that the weighted frequency of depressive PD was 52%.

Investigators' previous study on non-motor symptoms in 81 Chinese PD patients demonstrated that prevalence of loss of interest and depression(sadness) were 48.7% and 36.7% by Non-motor symptoms questionnaire (NMSQuest) separately, which was similar to average global data. But another Chinese data published in 2008 showed that the prevalence of depression in PD patients was only 12%, no statistical difference with controls(2%). Thus, investigators plan to initiate a larger study to understand if PD depression in China is similar to it in western countries.

Depression would occur at the early stage of the disease or proceed the motor symptoms, usually accompanied with other non-motor symptoms including apathy, sleep disorder, cognitive impairment, and etc. The effects of depression on quality of life might refer to a wider range. There is lack of solid data to reveal the harm of depression on quality of life of PD patients and caregivers. In clinical practice, the disease burden of PD depression is usually underestimated by physicians and patients.

Although PD depression affects QoL of patients and caregivers, PD depression would be relieved by medication, which was clearly recommended by international and Chinese PD guidelines. But the PD depression treatment status in Chinese clinical practice is not systematically analyzed before. In this study, investigator will summarize the treatment profile of PD depression to see if PD depression is properly treated according to guideline.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• The incidence of depression in patients of Parkinson's disease (DSM-5 diagnostic criteria for depression)

Exclusion Criteria:

• Inability to understand or answer questions for any reason,that would interfere our assessment.

• Participate in a concurrent clinical trial.

Related Conditions & MeSH terms

• Depression
• Parkinson Disease

Intervention

Other:
• no intervention
no intervention

Locations

Country	Name	City	State
China	Department of Neurology,Nanjing Brain Hospital,Nanjing Medical University	Nanjing
China	Department of Neurology, Longhua Hospital, Shanghai University of Traditional Chinese Medicine	Shanghai
China	Department of Neurology, Shanghai Tongji Hospital, Tongji University School of Medicine	Shanghai
China	Zhongshan Hospital & Shanghai Medical College, Fudan University	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

References & Publications (1)

Gan J, Zhou M, Chen W, Liu Z. Non-motor symptoms in Chinese Parkinson's disease patients. J Clin Neurosci. 2014 May;21(5):751-4. doi: 10.1016/j.jocn.2013.07.015. Epub 2013 Sep 11. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of depression in patients of Parkinson's disease (DSM-5 diagnostic criteria for depression)		through study completion, an average of 1 year