Psychiatric and Cognitive Manifestations of Parkinson's Disease
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| ClinicalTrials.gov Identifier: NCT00360633 |
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Recruitment Status :
Enrolling by invitation
First Posted : August 4, 2006
Last Update Posted : April 20, 2018
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Sponsor:
New York University School of Medicine
Information provided by (Responsible Party):
New York University School of Medicine
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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 |
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 |
| Estimated Enrollment : | 500 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 |
| Estimated Primary Completion Date : | December 2020 |
| Estimated Study Completion Date : | December 2020 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Parkinson disease
MedlinePlus related topics:
Parkinson's Disease
Primary Outcome Measures :
- Non-motor symptom progression [ Time Frame: Chronic ]
Secondary Outcome Measures :
- 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
- 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
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
Locations
| United States, New York | |
| NYU School of Medicine | |
| New York, New York, United States, 10016 | |
Sponsors and Collaborators
New York University School of Medicine
Investigators
| Principal Investigator: | Melissa J Nirenberg, MD, PhD | NYU School of Medicine |
Additional Information:
| Responsible Party: | New York University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT00360633 History of Changes |
| Other Study ID Numbers: |
12-03082 |
| First Posted: | August 4, 2006 Key Record Dates |
| Last Update Posted: | April 20, 2018 |
| Last Verified: | April 2018 |
| Studies a U.S. FDA-regulated Drug Product: | No | |
| Studies a U.S. FDA-regulated Device Product: | No | |
Keywords provided by New York University School of Medicine:
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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:
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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 Signs and Symptoms |