Clinical trial NCT00349310: Profile of Depressive Symptoms in Parkinsons Disease
Official title: Profile of Depressive Symptoms in Parkinson's Disease (PRODEST-PD)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson Disease
Depression
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2006-07-06
Enrollment: 1018
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

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.


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

Primary outcomes:
measure: HADS, HAMD-17, BDI-1A, FAB (cognitive), DSM-IV (mood- part A, B, C, E) and UPDRS
timeFrame: Up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Wien
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Wien
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Toulouse cedex 9
country: France
facility: Hopital Rangueil
city: Toulouse cedex
country: France
facility: Hopital Purpan
city: Beelitz-Heilstatten
country: Germany
facility: Neurologisches Fachkrankenhaus fur
city: Dresden
country: Germany
facility: Universitatsklinikum Carl Gustav Carus Dresden
city: Gera
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Leun
country: Germany
facility: Gertrudis-Kliniken Biskirchen
city: Unterhaching
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Wolfach
country: Germany
facility: Parkinson Klinik Wolfach
city: Catania
country: Italy
facility: Policlinico di Catania
city: Genova
country: Italy
facility: Azienda Ospedaliera S. Martino
city: Napoli
country: Italy
facility: Universita Federico II
city: Roma
country: Italy
facility: Universita La Sapienza di Roma
city: Maastricht
country: Netherlands
facility: Academisch Ziekenhuis Maastricht
city: Baracaldo / Bilbao
country: Spain
facility: Hospital de Cruces. Neurology
city: Barcelona
country: Spain
facility: Hospital Clinic i Provincial. Neurology
city: Cadiz
country: Spain
facility: Hospital Puerta del Mar. Neurology
city: Brissago
country: Switzerland
facility: Clinica Hildebrand
city: Geneve
country: Switzerland
facility: Hopital Cantonal (HUG)
city: St.Gallen
country: Switzerland
facility: Kantonsspital St. Gallen
city: London
country: United Kingdom
facility: Boehringer Ingelheim Investigational Site
city: Newark
country: United Kingdom
facility: Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim BV/Alkmaar
name: Boehringer Ingelheim Study Coordinator
role: STUDY_CHAIR
References: