Psychiatric and Cognitive Manifestations of Parkinson's Disease

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by New York University School of Medicine
Sponsor:
Information provided by (Responsible Party):
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT00360633
First received: August 2, 2006
Last updated: January 22, 2014
Last verified: January 2014
  Purpose

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
Parkinson's Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Psychiatric and Cognitive Manifestations of Parkinson's Disease: A Prospective Cohort Study

Resource links provided by NLM:


Further study details as provided by New York University School of Medicine:

Primary Outcome Measures:
  • Non-motor symptom progression [ Time Frame: Chronic ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Motor symptom progression [ Time Frame: Chronic ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: June 2006
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
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:

  • Dementia (MMSE <25)
  • Terminal illness (life expectancy < 12 months)
  • Presence of a neurodegenerative disorder other than Parkinson's Disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00360633

Contacts
Contact: Sara Rosenberg 212-263-7042 sara.rosenberg@nyumc.org
Contact: Melissa J Nirenberg, MD, PhD 212-263-4838 melissa.nirenberg@nyumc.org

Locations
United States, New York
NYU School of Medicine Recruiting
New York, New York, United States, 10016
Contact: Sara Rosenberg    212-263-7042    sara.rosenberg@nyumc.org   
Contact: Melissa J Nirenberg, MD, PhD    212-263-4838    melissa.nirenberg@nyumc.org   
Principal Investigator: Melissa J Nirenberg, MD, PhD         
Sub-Investigator: Rebecca Gilbert, MD, PhD         
Sub-Investigator: Alessandro Di Rocco, MD         
Sub-Investigator: Miroslaw Brys, MD, PhD         
Sponsors and Collaborators
New York University School of Medicine
Investigators
Principal Investigator: Melissa J Nirenberg, MD, PhD NYU School of Medicine
  More Information

Additional Information:
No publications provided

Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT00360633     History of Changes
Other Study ID Numbers: 0605008534
Study First Received: August 2, 2006
Last Updated: January 22, 2014
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on September 22, 2014