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Psychiatric and Cognitive Manifestations of Parkinson's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00360633
Recruitment Status : Completed
First Posted : August 4, 2006
Last Update Posted : May 10, 2019
Information provided by (Responsible Party):
NYU Langone Health

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.

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Study Type : Observational
Actual Enrollment : 36 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
Actual Primary Completion Date : March 28, 2019
Actual Study Completion Date : March 28, 2019

Resource links provided by the National Library of Medicine

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

Secondary Outcome Measures :
  1. Motor symptom progression [ Time Frame: Chronic ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00360633

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United States, New York
NYU School of Medicine
New York, New York, United States, 10016
Sponsors and Collaborators
NYU Langone Health
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Principal Investigator: Melissa J Nirenberg, MD, PhD NYU School of Medicine
Additional Information:
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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT00360633    
Other Study ID Numbers: 12-03082
First Posted: August 4, 2006    Key Record Dates
Last Update Posted: May 10, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by NYU Langone Health:
Parkinson's Disease
Impulse control disorder
Dopamine agonist withdrawal syndrome
Healthcare Utilization
Quality of life
Cognitive function
Wearing off
Additional relevant MeSH terms:
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Parkinson Disease
Neurobehavioral Manifestations
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Neurologic Manifestations