Clinical trial NCT00360633: Psychiatric and Cognitive Manifestations of Parkinson's Disease
Official title: Psychiatric and Cognitive Manifestations of Parkinson's Disease: A Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson's Disease
Keywords: 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
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2006-08-04
Enrollment: 36
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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

Primary outcomes:
measure: Non-motor symptom progression
timeFrame: Chronic
Secondary outcomes:
measure: Motor symptom progression
timeFrame: Chronic
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU School of Medicine
state: New York
Study officials:
affiliation: NYU School of Medicine
name: Melissa J Nirenberg, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: