|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
19 December 2023 |
|
Main ID: |
NCT00349310 |
|
Date of registration:
|
05/07/2006 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Profile of Depressive Symptoms in Parkinsons Disease
|
|
Scientific title:
|
Profile of Depressive Symptoms in Parkinson's Disease (PRODEST-PD) |
|
Date of first enrolment:
|
April 1, 2006 |
|
Target sample size:
|
1018 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/ct2/show/NCT00349310 |
|
Study type:
|
Observational |
|
Study design:
|
|
|
Phase:
|
|
|
|
Countries of recruitment
|
|
Austria
|
France
|
Germany
|
Italy
|
Netherlands
|
Spain
|
Switzerland
|
United Kingdom
|
|
Contacts
|
|
Name:
|
Boehringer Ingelheim Study Coordinator |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Boehringer Ingelheim BV/Alkmaar |
| | |
|
Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Depression
|
|
Parkinson Disease
|
|
Intervention(s)
|
|
Drug: Pramipexole
|
|
Primary Outcome(s)
|
|
HADS, HAMD-17, BDI-1A, FAB (cognitive), DSM-IV (mood- part A, B, C, E) and UPDRS
[Time Frame: Up to 6 months]
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|