- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00360633
Psychiatric and Cognitive Manifestations of Parkinson's Disease
May 8, 2019 updated by: NYU Langone Health
Psychiatric and Cognitive Manifestations of Parkinson's Disease: A Prospective Cohort Study
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.
Study Overview
Status
Completed
Conditions
Detailed 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.
Study Type
Observational
Enrollment (Actual)
36
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
New York, New York, United States, 10016
- NYU School of Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
- Patients with Parkinson's Disease who are seen for their routine medical care at the NYU Parkinson's and Movement Disorders Center.
- Matched healthy control subjects.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Non-motor symptom progression
Time Frame: Chronic
|
Chronic
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Motor symptom progression
Time Frame: Chronic
|
Chronic
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Melissa J Nirenberg, MD, PhD, NYU School of Medicine
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2006
Primary Completion (Actual)
March 28, 2019
Study Completion (Actual)
March 28, 2019
Study Registration Dates
First Submitted
August 2, 2006
First Submitted That Met QC Criteria
August 2, 2006
First Posted (Estimate)
August 4, 2006
Study Record Updates
Last Update Posted (Actual)
May 10, 2019
Last Update Submitted That Met QC Criteria
May 8, 2019
Last Verified
May 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 12-03082
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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