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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
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

Tracking Information
First Submitted Date August 2, 2006
First Posted Date August 4, 2006
Last Update Posted Date May 10, 2019
Study Start Date June 2006
Actual Primary Completion Date March 28, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 11, 2013)
Non-motor symptom progression [ Time Frame: Chronic ]
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures
 (submitted: July 11, 2013)
Motor symptom progression [ Time Frame: Chronic ]
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Psychiatric and Cognitive Manifestations of Parkinson's Disease
Official Title Psychiatric and Cognitive Manifestations of Parkinson's Disease: A Prospective Cohort Study
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Parkinson's Disease
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 8, 2019)
36
Original Enrollment
 (submitted: August 2, 2006)
60
Actual Study Completion Date March 28, 2019
Actual Primary Completion Date March 28, 2019   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00360633
Other Study ID Numbers 12-03082
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Current Responsible Party NYU Langone Health
Original Responsible Party Not Provided
Current Study Sponsor NYU Langone Health
Original Study Sponsor Weill Medical College of Cornell University
Collaborators Not Provided
Investigators
Principal Investigator: Melissa J Nirenberg, MD, PhD NYU School of Medicine
PRS Account NYU Langone Health
Verification Date May 2019