Psychiatric and Cognitive Manifestations of Parkinson's Disease

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief 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.

Condition or disease
Parkinson's Disease

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 Design

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Study Type :	Observational
Estimated Enrollment :	500 participants
Observational Model:	Cohort
Time Perspective:	Prospective
Official Title:	Psychiatric and Cognitive Manifestations of Parkinson's Disease: A Prospective Cohort Study
Study Start Date :	June 2006
Estimated Primary Completion Date :	December 2020
Estimated Study Completion Date :	December 2020

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Outcome Measures

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Non-motor symptom progression [ Time Frame: Chronic ]

Secondary Outcome Measures :

1. Motor symptom progression [ Time Frame: Chronic ]

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	21 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

1. Patients with Parkinson's Disease who are seen for their routine medical care at the NYU Parkinson's and Movement Disorders Center.
2. Matched healthy control subjects.

Criteria

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

Contacts and Locations

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, New York
NYU School of Medicine
New York, New York, United States, 10016

Sponsors and Collaborators

New York University School of Medicine

Investigators

Principal Investigator:	Melissa J Nirenberg, MD, PhD	NYU School of Medicine

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

NYU Parkinson's Disease and Movement Disorders Center 

Responsible Party:	New York University School of Medicine
ClinicalTrials.gov Identifier:	NCT00360633 History of Changes
Other Study ID Numbers:	12-03082
First Posted:	August 4, 2006
Last Update Posted:	April 20, 2018
Last Verified:	April 2018

Studies a U.S. FDA-regulated Drug Product:		No
Studies a U.S. FDA-regulated Device Product:		No

Keywords provided by New York University School of Medicine:

Parkinson's Disease; Impulse control disorder; Dopamine agonist withdrawal syndrome; Anxiety; Depression; Healthcare Utilization; Disability	Quality of life; Cognitive function; Psychosis; Apathy; Dyskinesias; Wearing off

Additional relevant MeSH terms:

Parkinson Disease; Neurobehavioral Manifestations; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases	Nervous System Diseases; Movement Disorders; Neurodegenerative Diseases; Neurologic Manifestations; Signs and Symptoms