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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00360633
Other study ID # 12-03082
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 2006
Est. completion date March 28, 2019

Study information

Verified date May 2019
Source New York University School of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Parkinson's Disease (PD) is often thought of as affecting movement only. In fact, most patients also experience psychiatric and cognitive symptoms, sometimes from the disease itself, and sometimes as a side-effect of PD medications. The goals of this study are to evaluate the causes, effects, and clinical correlates of psychiatric and cognitive symptoms in PD.


Description:

Parkinson's Disease (PD) is defined by the presence of motor symptoms, but in recent years there has been increasing recognition of non-motor manifestations, including anxiety, depression, and cognitive symptoms. In addition, PD medications have been shown to cause impulse control disorders, cognitive changes, and non-motor withdrawal symptoms (dopamine agonist withdrawal syndrome) when they are discontinued. The goals of this study are to test the hypothesis that the presence of psychiatric and cognitive symptoms are associated with greater self-perceived disability (out of proportion to objective deficits), increased utilization of healthcare resources, and decreased quality of life. In addition, we will examine the clinical correlates of these psychiatric symptoms. To test these hypotheses, we will screen PD patients for anxiety, depression, impulse control disorders, and dopamine agonist withdrawal syndrome, and compare cases and controls with regard to demographic characteristics, motor features of PD, disability, healthcare utilization, and quality of life.


Recruitment information / eligibility

Status Completed
Enrollment 36
Est. completion date March 28, 2019
Est. primary completion date March 28, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 21 Years and older
Eligibility Inclusion Criteria:

- Diagnosis of idiopathic Parkinson's Disease (or healthy control subject)

- Age >=21 and <=99

- Capacity to provide informed consent

- Ability to complete the questionnaires

Exclusion Criteria:

- Clinical diagnosis of dementia

- Terminal illness (life expectancy < 12 months)

- Presence of a neurodegenerative disorder other than Parkinson's Disease

Study Design


Locations

Country Name City State
United States NYU School of Medicine New York New York

Sponsors (1)

Lead Sponsor Collaborator
New York University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Non-motor symptom progression Chronic
Secondary Motor symptom progression Chronic
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