NCT03026595

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

January 11, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 20, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

May 11, 2018

Status Verified

May 1, 2018

Enrollment Period

1.9 years

First QC Date

January 11, 2017

Last Update Submit

May 6, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

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

    through study completion, an average of 1 year

Interventions

no intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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%).

You may qualify if:

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

You may not qualify if:

  • Inability to understand or answer questions for any reason,that would interfere our assessment.
  • Participate in a concurrent clinical trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Department of Neurology,Nanjing Brain Hospital,Nanjing Medical University

Nanjing, China

RECRUITING

Department of Neurology, Longhua Hospital, Shanghai University of Traditional Chinese Medicine

Shanghai, China

RECRUITING

Department of Neurology, Shanghai Tongji Hospital, Tongji University School of Medicine

Shanghai, China

RECRUITING

Zhongshan Hospital & Shanghai Medical College, Fudan University

Shanghai, China

RECRUITING

Related 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.

    PMID: 24411328BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Zhenguo Liu

    Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2017

First Posted

January 20, 2017

Study Start

January 1, 2017

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

May 11, 2018

Record last verified: 2018-05

Locations