The neurobiological correlates of anhedonic depression in Parkinson*s disease; associations between dopamine function and functional pathways
- Conditions
- depressionParkinson's disease1002803710027946
- Registration Number
- NL-OMON54140
- Lead Sponsor
- Radboud Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 75
For the present study, we will select patients from the PPP and PRIME cohorts
and from clinical samples from neurologists embedded in Parkinsonnet and/or in
the service area of the RadboudUMC. The PPP study is a pro-spective,
longitudinal, single-center cohort study of the Radboudumc in the Netherlands
which started in October 2017. Enrollment period will take 2 years, in which a
total of 650 adult patients diagnosed with PD with <=5 years duration will be
included. PRIME is a prospective longitudinal study of the RadboudUMC of the
Netherlands which started in 2019 and enrolls 1200 patients with either
clinically diagnosed PD or parkinsonism.
ParkinsonNet is an innovative health care concept that consists of 70
professional networks for PD covering all of the Netherlands
In order to be eligible to participate in this study, a subject must meet all
of the following criteria:
• A diagnosis of PD with <=10 years duration, defined as time since diagnosis
made by a neurologist.
• Subject can read and understand Dutch.
• Subject is willing, competent, and able to comply with all aspects of the
protocol
• meeting DSM-criteria for a depression including the criterium of a sad mood
(depressed PD group)
• in the 5 past years and/or currently not meeting DSM-criteria for a
depression (non-depressed PD control group)
A potential subject who meets any of the following criteria will be excluded
from participation in this study:
• Contraindications for MRI, e.g., claustrophobia, presence of an active
implant, pacemaker, insulin pump, neurostimulator, ossicle prosthesis,
pregnancy, and/or other medical device or other non-removable metal part
incompatible with MRI.
• Contraindications for PET e.g., inability to lie flat or lie still for the
duration of the scan, claustrophobia (occasionally).
• Use of medication or drugs with evident DAT-binding like methylphenidate,
buproprion, amphetamines, cocaine that cannot be discontinued according to the
PET-protocol. Note that we allow use of anti-depressants with the exception of
those antidepressants with a high DAT binding defined as a relatively low Ki of
<1000 (, i.e. for the Netherlands buproprion, duloxetine and sertraline).
Moreover, we will exclude patients using antidepressants at higher than minimal
effective dosages used for antidepressive effects when the Ki is <10000 (i.e.
for the Netherlands amitryptiline, clomipramine, maprotiline, nortriptyline,
fluoxetine, paroxetine).
• Being diagnosed with dementia (defined as a Montreal Cognitive Assessment
(MoCA) <21/30 (Dalymple-Alford 2010), assessed ON Parkinson medication).
• Psychiatric diagnosis of bipolar disorder.
• Presence of current psychotic symptoms.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Differences between (anhedonic and non-anhedonic) depressed PD patients and<br /><br>non-depressed PD patients in: (1) Baseline DAT-availability measured with PET;<br /><br>(2) Functional connectivity from seeds with aberrant DAT-availability compared<br /><br>to non-depressed PD. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Differences between (anhedonic and non-anhedonic) depressed PD patients and<br /><br>non-depressed PD patients in effort-reward weighting on an<br /><br>effort-reward-choice-task (ERCT), fMRI-based BOLD signal when performing the<br /><br>ERCT during the decisional phase, fMRI-based BOLD signal when performing a<br /><br>reinforcement learning task, neuromelanin, and subjective self-report<br /><br>measurements assessing depression, anhedonia, apathy and anxiety.</p><br>