Clinical trial NCT00651183: Non-motor Symptoms (Depressive Symptoms) of Parkinson's Disease and Their Course Under Pramipexole Treatment
Official title: Non-motor Symptoms (Depressive Symptoms) of Parkinson's Disease and Their Course Under Pramipexole Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson Disease
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2008-04-02
Enrollment: 286
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: PD patients

Brief summary: The objective of this PMS study is the evaluation of depressive symptoms measured with Unified Parkinson's Disease Rating Scale (UPDRS) Part I (mentation, behavior and mood) and with Hospital Anxiety and Depression Scale Depression Subscore (HADS-D) under pramipexole treatment in early and advanced PD patients. In addition it will be investigated whether improvement of depressive symptoms is linked to improvement in motor function (UPDRS Part III). 250 patients diagnosed with Parkinson's disease (PD) will be investigated by 80 specialists (neurologists or neurologists/psychiatrists) across Austria. Pramipexole will be taken orally at an initial dosage of 0.375 mg/day (using a three times daily schedule independently of food intake) and can be titrated upwards, as required, at weekly intervals to a maximum total daily dose of 4,5 mg (TID) as per Summary of Product Characteristics (SPC).


Eligibility criteria: Inclusion Criteria:

* Idiopathic PD with or without fluctuations
* Indication for treatment with Pramipexole
* Presence of at least mild depressive symptoms (as judged by the treating physician)
* Ability to reliably complete a self-rating scale (Hospital Anxiety and Depression Scale (HADS))

Exclusion Criteria:

* Any contraindications according to the Summary of Product Characteristics (SPC), hypersensitivity to pramipexole or to any of the excipients
* Ongoing treatment with pramipexole

Primary outcomes:
measure: Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part I (Mentation, Behaviour and Mood)
timeFrame: Baseline and Final (visit 3) - Change from baseline (i.e. decrease of score)
measure: Change From Baseline in Hospital Anxiety and Depression Scale - HADS-D Depression Subscore
timeFrame: Baseline and Final (visit 3) - Change from baseline (i.e. decrease of score)
measure: Change From Baseline in Hospital Anxiety and Depression Scale - HADS-A Anxiety Subscore
timeFrame: Baseline and Final (visit 3) - Change from baseline (i.e. decrease of score)
measure: Change From Baseline in UPDRS Part III (Motor Examination)
timeFrame: Baseline and Final (visit 3) - Change from baseline (i.e. decrease of score)
Secondary outcomes:
Other outcomes:
Locations:
city: Amstetten
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Bad Hall
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Bad Ischl
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Bad Radkersburg
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Baden
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Bregenz
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Bruck an der Mur
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Deutschlandsberg
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Dornbirn
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Eisenstadt
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Feldkirchen
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Feldkirch
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Gmunden
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Graz
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Grieskirchen
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Gänserndorf
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Hall in Tirol
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Hallein
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Hermagor
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Hohenems
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Hollabrunn
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Horn
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Imst
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Innsbruck
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Judenburg
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Kapfenberg
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Klagenfurt
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Klosterneuburg
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Knittelfeld
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Krems
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Kufstein
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Leoben
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Lienz
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Lilienfeld
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Linz
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Melk
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Neunkirchen
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Oberwart
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Ried im Innkreis
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Salzburg
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Scheibbs
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Schwechat
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Spital an der Drau
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: St. Johann im Pongau
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: St. Pölten
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: St. Veit an der Glan
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Stegersbach
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Stockerau
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Telfs
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Traun
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Villach
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Vöcklabruck
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: W. Neustadt
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Wels
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Wien
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Wolfsberg
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Wörgl
country: Austria
facility: Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim Study Coordinator
role: STUDY_CHAIR
References: