NCT00349310

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,018

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2006

Shorter than P25 for all trials

Geographic Reach
8 countries

24 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 5, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 6, 2006

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2006

Completed
Last Updated

December 14, 2023

Status Verified

December 1, 2023

Enrollment Period

6 months

First QC Date

July 5, 2006

Last Update Submit

December 7, 2023

Conditions

Parkinson DiseaseDepression

Outcome Measures

Primary Outcomes (1)

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

    Up to 6 months

Interventions

PramipexoleDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (24)

Boehringer Ingelheim Investigational Site

Innsbruck, 6020, Austria

Location

Boehringer Ingelheim Investigational Site

Vienna, 1090, Austria

Location

Boehringer Ingelheim Investigational Site

Vienna, 1130, Austria

Location

Hopital Rangueil

Toulouse, 31059, France

Location

Hopital Purpan

Toulouse, 31073, France

Location

Neurologisches Fachkrankenhaus fur

Beelitz-Heilstätten, 14547, Germany

Location

Universitatsklinikum Carl Gustav Carus Dresden

Dresden, 01307, Germany

Location

Boehringer Ingelheim Investigational Site

Gera, 07551, Germany

Location

Gertrudis-Kliniken Biskirchen

Leun, 35638, Germany

Location

Boehringer Ingelheim Investigational Site

Unterhaching, 82008, Germany

Location

Parkinson Klinik Wolfach

Wolfach, 77709, Germany

Location

Policlinico di Catania

Catania, 95125, Italy

Location

Azienda Ospedaliera S. Martino

Genova, 16100, Italy

Location

Universita Federico II

Napoli, 80131, Italy

Location

Universita La Sapienza di Roma

Roma, 00161, Italy

Location

Academisch Ziekenhuis Maastricht

Maastricht, 6229 HX, Netherlands

Location

Hospital de Cruces. Neurology

Baracaldo / Bilbao, 48903, Spain

Location

Hospital Clinic i Provincial. Neurology

Barcelona, 08036, Spain

Location

Hospital Puerta del Mar. Neurology

Cadiz, 11519, Spain

Location

Clinica Hildebrand

Brissago, 6614, Switzerland

Location

Hopital Cantonal (HUG)

Geneva, 1211, Switzerland

Location

Kantonsspital St. Gallen

Sankt Gallen, 9007, Switzerland

Location

Boehringer Ingelheim Investigational Site

London, NW3 2QG, United Kingdom

Location

Boehringer Ingelheim Investigational Site

Newark, NG24 4DE, United Kingdom

Location

MeSH Terms

Conditions

Parkinson DiseaseDepression

Interventions

Pramipexole

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

BenzothiazolesThiazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Boehringer Ingelheim Study Coordinator

    Boehringer Ingelheim BV/Alkmaar

    STUDY CHAIR

Study Design

Study Type
observational
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 5, 2006

First Posted

July 6, 2006

Study Start

April 1, 2006

Primary Completion

October 1, 2006

Study Completion

October 1, 2006

Last Updated

December 14, 2023

Record last verified: 2023-12

Locations

AU(3)GB(2)DE(6)IT(4)FR(2)ES(3)NL(1)CH(3)