Clinical trial NCT03026595: The Profile of the Depression and it's Intervention Strategy in Patients With Parkinson's Disease in China
Official title: The Profile of the Depression and it's Intervention Strategy in Patients With Parkinson's Disease in China
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Parkinson Disease
Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2017-01-20
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The estimated proportion of depression in patients with PD is around 50%. With 500 patients, the length of 95% CI of proportion of depression in PD patients will be less than 0.09 (the widest 95% confidence interval 0.088 will be attained only when the estimated proportion is 50%).

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: The incidence of depression in patients of Parkinson's disease (DSM-5 diagnostic criteria for depression)
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Department of Neurology,Nanjing Brain Hospital,Nanjing Medical University
city: Shanghai
country: China
facility: Department of Neurology, Longhua Hospital, Shanghai University of Traditional Chinese Medicine
city: Shanghai
country: China
facility: Department of Neurology, Shanghai Tongji Hospital, Tongji University School of Medicine
city: Shanghai
country: China
facility: Zhongshan Hospital & Shanghai Medical College, Fudan University
Study officials:
affiliation: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
name: Zhenguo Liu
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.