Psychiatric and Cognitive Manifestations of Parkinson's Disease
This study is currently recruiting participants.
(see Contacts and Locations)
Verified July 2016 by New York University School of Medicine
Sponsor:
New York University School of Medicine
Information provided by (Responsible Party):
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT00360633
First received: August 2, 2006
Last updated: July 19, 2016
Last verified: July 2016
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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: | December 2016 |
| Estimated Primary Completion Date: | December 2016 (Final data collection date for primary outcome measure) |
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 (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Study Population
- Patients with Parkinson's Disease who are seen for their routine medical care at the NYU Parkinson's and Movement Disorders Center.
- 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
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00360633
Contacts
| Contact: Kathryn Montgomery | 212-263-7042 | kathryn.montgomery@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: Kathryn Montgomery 212-263-7042 kathryn.montgomery@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:
| 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: | July 19, 2016 |
| 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 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 |
ClinicalTrials.gov processed this record on September 28, 2016