Status:
COMPLETED
Rasagiline and Apathy in Parkinson's Disease
Lead Sponsor:
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Conditions:
Parkinson's Disease
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to determine whether rasagiline is effective in the treatment of apathy in patients with Parkinson's disease.
Detailed Description
The primary objective of this study is to evaluate the efficacy of rasagiline in patients with Parkinson's disease (PD) and apathy. Secondary objectives are 1) to evaluate the affective and cognitive ...
Eligibility Criteria
Inclusion
- Patients with idiopathic PD optimally treated for their motor deficits with stable doses of L-Dopa and/or dopamine agonists and showing a non-zero score on the item 4 (motivation/initiative) of the Unified Parkinson's Disease Rating Scale (UPDRS)
Exclusion
- Dementia associated to PD according to DSM IV criteria. History of primary psychiatric illness or Axis I diagnoses according to the Structured Clinical Interview for DSM-IV
- Patients complaining of acute mood or cognitive fluctuations in response to dopaminergic medication
- Patients treated with any MAO inhibitor (including Selegiline), fluoxetine and fluvoxamine during the previous month before inclusion. Also will be excluded patients with a neurological disorder other than PD, any unstable systemic disease and pregnant or possibly pregnant women
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00755027
Start Date
September 1 2008
End Date
June 1 2014
Last Update
August 10 2015
Active Locations (1)
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1
Fundacio de Gestio Sanitaria de l'Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona, Spain, 08025