Non-motor Symptoms (Depressive Symptoms) of Parkinson's Disease and Their Course Under Pramipexole Treatment

Parkinson Disease Clinical Trial

Official title:

Non-motor Symptoms (Depressive Symptoms) of Parkinson's Disease and Their Course Under Pramipexole Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00651183
• Other study ID #: 248.649
• Status: Completed
• Phase: Phase 4
• First received: March 31, 2008
• Last updated: May 9, 2014
• Est. completion date: April 2008

Study information

• Verified date: May 2014
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Bundesamt für Sicherheit im GesundheitswesenUnited States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 286
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Drug:
• Pramipexole immediate release

Locations

Country	Name	City	State
Austria	Boehringer Ingelheim Investigational Site	Amstetten
Austria	Boehringer Ingelheim Investigational Site	Bad Hall
Austria	Boehringer Ingelheim Investigational Site	Bad Ischl
Austria	Boehringer Ingelheim Investigational Site	Bad Radkersburg
Austria	Boehringer Ingelheim Investigational Site	Baden
Austria	Boehringer Ingelheim Investigational Site	Bregenz
Austria	Boehringer Ingelheim Investigational Site	Bruck an der Mur
Austria	Boehringer Ingelheim Investigational Site	Deutschlandsberg
Austria	Boehringer Ingelheim Investigational Site	Dornbirn
Austria	Boehringer Ingelheim Investigational Site	Eisenstadt
Austria	Boehringer Ingelheim Investigational Site	Feldkirch
Austria	Boehringer Ingelheim Investigational Site	Feldkirchen
Austria	Boehringer Ingelheim Investigational Site	Gänserndorf
Austria	Boehringer Ingelheim Investigational Site	Gmunden
Austria	Boehringer Ingelheim Investigational Site	Graz
Austria	Boehringer Ingelheim Investigational Site	Grieskirchen
Austria	Boehringer Ingelheim Investigational Site	Hall in Tirol
Austria	Boehringer Ingelheim Investigational Site	Hallein
Austria	Boehringer Ingelheim Investigational Site	Hermagor
Austria	Boehringer Ingelheim Investigational Site	Hohenems
Austria	Boehringer Ingelheim Investigational Site	Hollabrunn
Austria	Boehringer Ingelheim Investigational Site	Horn
Austria	Boehringer Ingelheim Investigational Site	Imst
Austria	Boehringer Ingelheim Investigational Site	Innsbruck
Austria	Boehringer Ingelheim Investigational Site	Judenburg
Austria	Boehringer Ingelheim Investigational Site	Kapfenberg
Austria	Boehringer Ingelheim Investigational Site	Klagenfurt
Austria	Boehringer Ingelheim Investigational Site	Klosterneuburg
Austria	Boehringer Ingelheim Investigational Site	Knittelfeld
Austria	Boehringer Ingelheim Investigational Site	Krems
Austria	Boehringer Ingelheim Investigational Site	Kufstein
Austria	Boehringer Ingelheim Investigational Site	Leoben
Austria	Boehringer Ingelheim Investigational Site	Lienz
Austria	Boehringer Ingelheim Investigational Site	Lilienfeld
Austria	Boehringer Ingelheim Investigational Site	Linz
Austria	Boehringer Ingelheim Investigational Site	Melk
Austria	Boehringer Ingelheim Investigational Site	Neunkirchen
Austria	Boehringer Ingelheim Investigational Site	Oberwart
Austria	Boehringer Ingelheim Investigational Site	Ried im Innkreis
Austria	Boehringer Ingelheim Investigational Site	Salzburg
Austria	Boehringer Ingelheim Investigational Site	Scheibbs
Austria	Boehringer Ingelheim Investigational Site	Schwechat
Austria	Boehringer Ingelheim Investigational Site	Spital an der Drau
Austria	Boehringer Ingelheim Investigational Site	St. Johann im Pongau
Austria	Boehringer Ingelheim Investigational Site	St. Pölten
Austria	Boehringer Ingelheim Investigational Site	St. Veit an der Glan
Austria	Boehringer Ingelheim Investigational Site	Stegersbach
Austria	Boehringer Ingelheim Investigational Site	Stockerau
Austria	Boehringer Ingelheim Investigational Site	Telfs
Austria	Boehringer Ingelheim Investigational Site	Traun
Austria	Boehringer Ingelheim Investigational Site	Villach
Austria	Boehringer Ingelheim Investigational Site	Vöcklabruck
Austria	Boehringer Ingelheim Investigational Site	W. Neustadt
Austria	Boehringer Ingelheim Investigational Site	Wels
Austria	Boehringer Ingelheim Investigational Site	Wien
Austria	Boehringer Ingelheim Investigational Site	Wolfsberg
Austria	Boehringer Ingelheim Investigational Site	Wörgl

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part I (Mentation, Behaviour and Mood)	Rating scale scored from 0 (none) - 4 (severe). The UPDRS Part I (Mentation, Behaviour and Mood during the Past Week) consist of 4 items, each of them is scored from 0 (normal) to 4 (severe). Reduction in this score over time is interpreted as improvement.; Total UPDRS part I score ranges from 0 = best score to 16 = worst score	Baseline and Final (visit 3) - Change from baseline (i.e. decrease of score)	No
Primary	Change From Baseline in Hospital Anxiety and Depression Scale - HADS-D Depression Subscore	Depression Scale - 7 items scored for each individual question from 0 = best and 3 = worst.; HADS is a self-assessment scale for the symptom severity of anxiety disorders and depression.; It comprises of 14 items, thereof seven statements describe anxiety and seven statements depression. Each answer is rated on a four-point scale (0-3). All seven answers are summarized and calculated to a total score to the anxiety scale and to the depression scale with a maximum score of 21 points for each scale.	Baseline and Final (visit 3) - Change from baseline (i.e. decrease of score)	No
Primary	Change From Baseline in Hospital Anxiety and Depression Scale - HADS-A Anxiety Subscore	Anxiety Scale - 7 items scored for each individual question from 0 = best and 3 = worst.; HADS is a self-assessment scale for the symptom severity of anxiety disorders and depression.; It comprises of 14 items, thereof seven statements describe anxiety and seven statements depression. Each answer is rated on a four-point scale (0-3). All seven answers are summarized and calculated to a total score to the anxiety scale and to the depression scale with a maximum score of 21 points for each scale.	Baseline and Final (visit 3) - Change from baseline (i.e. decrease of score)	No
Primary	Change From Baseline in UPDRS Part III (Motor Examination)	14 components rating scale with 27 items scored by 0 (none) - 4 (severe)	Baseline and Final (visit 3) - Change from baseline (i.e. decrease of score)	No