Parkinson's DiseaseNCT00518258
Neuroimaging Studies of Depression in Parkinson's Disease
An observational study of Parkinson's Disease, run by Lee Blonder at 1 site in United States.
Trial summary
The purpose of this study is to investigate similarities and differences in the neural pathways of depressed Parkinson's patients, non-depressed Parkinson's patients, and healthy controls using magnetic resonance imaging (MRI) of the brain and neuropsychological assessment. Read more about this study
- Who is it for?
- Ages 40 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson's Disease
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2006to Dec 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Neurology clinics, community sample
Who may be able to join
- right-handed
- willing/able to undergo magnetic resonance imaging (MRI)
Who cannot join
- history of neurological condition other than Parkinson's disease
- history of psychiatric condition other than depression
- history of substance abuse/dependence
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to investigate similarities and differences in the neural pathways of depressed Parkinson's patients, non-depressed Parkinson's patients, and healthy controls using magnetic resonance imaging (MRI) of the brain and neuropsychological assessment.
Read the detailed description
Depression is a common and potentially serious complication of Parkinson's disease (PD). Studies show that approximately 40 percent of PD patients are depressed. There is evidence that these patients have deficits in neuropsychological function relative to non-depressed PD patients. Despite the widespread toll on emotional health posed by PD, few studies have undertaken a comprehensive examination of the neural underpinnings of Parkinsonian depression. In this project, we will compare depressed versus non-depressed Parkinson patients to a sample of demographically-matched healthy controls using neuropsychological assessment and magnetic resonance imaging (MRI). To investigate possible effects of anti-Parkinsonian medication on mood, cognitive function, and neural response, PD patients will be tested both off and on Parkinsonian medications.
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's Disease, Magnetic Resonance Imaging (MRI), neuropsychological assessment
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Patient Group | |
| 2 | Control Group |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2007 (estimated)
- Study startJul 2006
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lee Blonder
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), National Institute of Neurological Disorders and Stroke (NINDS)
- Responsible party
- Sponsor-investigator, Lee Blonder, University of Kentucky
- Investigators
- Lee X. Blonder, PhD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00518258
- Sponsor's protocol ID
- R01-MH78228-2
- Other IDs
- R01MH078228
- Status last verified
- Apr 2013
- First submitted
- 16 Aug 2007
- Last updated
- 17 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuroimaging Studies of Depression in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT00518258
- Acronym / sponsor ID
- R01-MH78228-2
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's Disease, Magnetic Resonance Imaging (MRI), neuropsychological assessment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Lee BlonderUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- Jul 2006
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 20 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate similarities and differences in the neural pathways of depressed Parkinson's patients, non-depressed Parkinson's patients, and healthy controls using magnetic resonance imaging (MRI) of the brain and neuropsychological assessment.
Detailed description
Depression is a common and potentially serious complication of Parkinson's disease (PD). Studies show that approximately 40 percent of PD patients are depressed. There is evidence that these patients have deficits in neuropsychological function relative to non-depressed PD patients. Despite the widespread toll on emotional health posed by PD, few studies have undertaken a comprehensive examination of the neural underpinnings of Parkinsonian depression. In this project, we will compare depressed versus non-depressed Parkinson patients to a sample of demographically-matched healthy controls using neuropsychological assessment and magnetic resonance imaging (MRI). To investigate possible effects of anti-Parkinsonian medication on mood, cognitive function, and neural response, PD patients will be tested both off and on Parkinsonian medications.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Patient Group |
| 2 | – | –Control Group |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Neurology clinics, community sample
Key inclusion criteria (2 listed)
- right-handed
- willing/able to undergo magnetic resonance imaging (MRI)
Key exclusion criteria (3 listed)
- history of neurological condition other than Parkinson's disease
- history of psychiatric condition other than depression
- history of substance abuse/dependence
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lee X. Blonder, PhD principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson's Disease, run by Lee Blonder at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2013.