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Profile of Depressive Symptoms in Parkinsons Disease

Primary Purpose

Parkinson Disease, Depression

Status
Completed
Phase
Locations
International
Study Type
Observational
Intervention
Pramipexole
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Parkinson Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion_Criteria: Observation criteria: are able to provide written informed consent in accordance with Good Clinical Practice (GCP) and local legislation have idiopathic Parkinsons disease according to the United Kingdom Parkinsons Disease Society Brain Bank Diagnostic Criteria for Parkinsons disease show no impairment of cognitive function (MMSE score ?24) are with or without symptoms of depression (full range) are stable on anti-Parkinson/anti-depressive treatment for at least 1 month before entering the study are or are not on concomitant antidepressant treatment are in the on state during the observation period did not previously undergo PD surgery

Sites / Locations

  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Hopital Rangueil
  • Hopital Purpan
  • Neurologisches Fachkrankenhaus fur
  • Universitatsklinikum Carl Gustav Carus Dresden
  • Boehringer Ingelheim Investigational Site
  • Gertrudis-Kliniken Biskirchen
  • Boehringer Ingelheim Investigational Site
  • Parkinson Klinik Wolfach
  • Policlinico di Catania
  • Azienda Ospedaliera S. Martino
  • Universita Federico II
  • Universita La Sapienza di Roma
  • Academisch Ziekenhuis Maastricht
  • Hospital de Cruces. Neurology
  • Hospital Clinic i Provincial. Neurology
  • Hospital Puerta del Mar. Neurology
  • Clinica Hildebrand
  • Hopital Cantonal (HUG)
  • Kantonsspital St. Gallen
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site

Outcomes

Primary Outcome Measures

HADS, HAMD-17, BDI-1A, FAB (cognitive), DSM-IV (mood- part A, B, C, E) and UPDRS

Secondary Outcome Measures

Full Information

First Posted
July 5, 2006
Last Updated
October 31, 2013
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT00349310
Brief Title
Profile of Depressive Symptoms in Parkinsons Disease
Official Title
Profile of Depressive Symptoms in Parkinson's Disease (PRODEST-PD)
Study Type
Observational

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
October 2006 (Actual)
Study Completion Date
October 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Boehringer Ingelheim

4. Oversight

5. Study Description

Brief Summary
To explore or establish the relationship between cognitive, mood and motor symptoms in PD to scores on depression rating scales in a naturalistic setting.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Depression

7. Study Design

Enrollment
1018 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Pramipexole
Primary Outcome Measure Information:
Title
HADS, HAMD-17, BDI-1A, FAB (cognitive), DSM-IV (mood- part A, B, C, E) and UPDRS

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion_Criteria: Observation criteria: are able to provide written informed consent in accordance with Good Clinical Practice (GCP) and local legislation have idiopathic Parkinsons disease according to the United Kingdom Parkinsons Disease Society Brain Bank Diagnostic Criteria for Parkinsons disease show no impairment of cognitive function (MMSE score ?24) are with or without symptoms of depression (full range) are stable on anti-Parkinson/anti-depressive treatment for at least 1 month before entering the study are or are not on concomitant antidepressant treatment are in the on state during the observation period did not previously undergo PD surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim Study Coordinator
Organizational Affiliation
Boehringer Ingelheim BV/Alkmaar
Official's Role
Study Chair
Facility Information:
Facility Name
Boehringer Ingelheim Investigational Site
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
Facility Name
Boehringer Ingelheim Investigational Site
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Boehringer Ingelheim Investigational Site
City
Wien
ZIP/Postal Code
1130
Country
Austria
Facility Name
Hopital Rangueil
City
Toulouse cedex 9
ZIP/Postal Code
31059
Country
France
Facility Name
Hopital Purpan
City
Toulouse cedex
ZIP/Postal Code
31073
Country
France
Facility Name
Neurologisches Fachkrankenhaus fur
City
Beelitz-Heilstatten
ZIP/Postal Code
14547
Country
Germany
Facility Name
Universitatsklinikum Carl Gustav Carus Dresden
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Gera
ZIP/Postal Code
07551
Country
Germany
Facility Name
Gertrudis-Kliniken Biskirchen
City
Leun
ZIP/Postal Code
35638
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Unterhaching
ZIP/Postal Code
82008
Country
Germany
Facility Name
Parkinson Klinik Wolfach
City
Wolfach
ZIP/Postal Code
77709
Country
Germany
Facility Name
Policlinico di Catania
City
Catania
ZIP/Postal Code
95125
Country
Italy
Facility Name
Azienda Ospedaliera S. Martino
City
Genova
ZIP/Postal Code
16100
Country
Italy
Facility Name
Universita Federico II
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Universita La Sapienza di Roma
City
Roma
ZIP/Postal Code
00161
Country
Italy
Facility Name
Academisch Ziekenhuis Maastricht
City
Maastricht
ZIP/Postal Code
6229 HX
Country
Netherlands
Facility Name
Hospital de Cruces. Neurology
City
Baracaldo / Bilbao
ZIP/Postal Code
48903
Country
Spain
Facility Name
Hospital Clinic i Provincial. Neurology
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Puerta del Mar. Neurology
City
Cadiz
ZIP/Postal Code
11519
Country
Spain
Facility Name
Clinica Hildebrand
City
Brissago
ZIP/Postal Code
6614
Country
Switzerland
Facility Name
Hopital Cantonal (HUG)
City
Geneve
ZIP/Postal Code
1211
Country
Switzerland
Facility Name
Kantonsspital St. Gallen
City
St.Gallen
ZIP/Postal Code
9007
Country
Switzerland
Facility Name
Boehringer Ingelheim Investigational Site
City
London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Facility Name
Boehringer Ingelheim Investigational Site
City
Newark
ZIP/Postal Code
NG24 4DE
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
http://trials.boehringer-ingelheim.com/wcms_opu/ctrr_prod/res/trial/data/pdf/248.597_synopsis.pdf
Description
Related Info

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Profile of Depressive Symptoms in Parkinsons Disease

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