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Reward mechanisms, mood and motivational symptoms in Parkinson's disease: an experimental approach.


- candidate number2862
- NTR NumberNTR1115
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR5-nov-2007
- Secondary IDsMEC 07-3-087 
- Public TitleReward mechanisms, mood and motivational symptoms in Parkinson's disease: an experimental approach.
- Scientific TitleReward mechanisms, mood and motivational symptoms in Parkinson's disease: an experimental approach.
- ACRONYMN/A
- hypothesisThis study tests the hypothesis that reward mechanisms in PD are dysfunctional and that this dysfunction is correlated with an increased severity of symptoms of apathy, depression and HDD.
- Healt Condition(s) or Problem(s) studiedParkinson's disease
- Inclusion criteria1. Idopathic Parkinson's disease;
2. Informed consent.
- Exclusion criteria1. Other concurrent neurological diseases than PD;
2. Concurrent psychiatric disease;
3. Use of psychopharmacological medication;
4. Abuse of alcohol and drugs;
5. Cognitive deterioration as operationalized by a score of <23 on the MMSE;
6. Use of levodopa preparations of dopamine agonists.
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-dec-2007
- planned closingdate1-dec-2010
- Target number of participants50
- InterventionsAll subjects receive a 10 mg methylphenidate challenge, a 500 ėg pramipexole challenge and a placebo condition.
- Primary outcomeMain study parameters are the performance on neuropsychiatric and neuropsychological tests for both groups, including assessments of cognitive status, mood, apathy, and an observation of spontaneous self-reward behaviour.
- Secondary outcomeN/A
- TimepointsThese outcome measures will be rated on three different testing days, before and after the administration of methylphenidate, pramipexole or placebo.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDrs. R.L. Drijgers
- CONTACT for SCIENTIFIC QUERIESDr. A.F.G. Leentjens
- Sponsor/Initiator University Hospital Maastricht (AZM)
- Funding
(Source(s) of Monetary or Material Support)
University Hospital Maastricht (AZM)
- PublicationsN/A
- Brief summaryIn Parkinson's disease (PD) degeneration of dopaminergic cells in the mesocorticolimbic pathway is implied int he pathophysiology of several non-motor symptoms related to motivation and reward, such as apathy, depression, and hedonistic homeostatic dysregulation (HDD), a syndrome that is characterized by obsessive behaviour, addiction, compusive seeking of dopamine replacement therapy (DRT), and hypersexuality. Apathy is reproted in 16 to 42 % of PD patients, while depression occurs in in 25 to 40 %. Both apathy and depression have a serious negative impact on everyday functioning, cognitive and motor performance and quality of life for both patient and partner or caretaker. HDD, although less prevalent (around 4% of patients), can also be severely disruptive. Insight in the pathophysiology of these syndromes may pave the way for rational treatments and improved outcomes.
- Main changes (audit trail)
- RECORD5-nov-2007 - 25-mrt-2008


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