Trial · NCT00651183
Non-motor Symptoms (Depressive Symptoms) of Parkinson's Disease and Their Course Under Pramipexole Treatment
NCT00651183, Completed, Boehringer Ingelheim; results first posted 2010-03-03
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Non-motor Symptoms (Depressive Symptoms) of Parkinson's Disease and Their Course Under Pramipexole Treatment. Trials, record NCT00651183. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00651183
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Non-motor Symptoms (Depressive Symptoms) of Parkinson's Disease and Their Course Under Pramipexole Treatment
- NCT number
- NCT00651183
- Status
- Completed
- Enrollment
- 286 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Parkinson Disease
- Interventions
- Pramipexole immediate release
- First posted
- 2008-04-02
- Last updated
- 2014-05-20
- Results first posted
- 2010-03-03
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part I (Mentation, Behaviour and Mood) | Baseline and Final (visit 3) - Change from baseline (i.e. decrease of score) | 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 |
| Primary | Change From Baseline in Hospital Anxiety and Depression Scale - HADS-D Depression Subscore | Baseline and Final (visit 3) - Change from baseline (i.e. decrease of score) | 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. |
| Primary | Change From Baseline in Hospital Anxiety and Depression Scale - HADS-A Anxiety Subscore | Baseline and Final (visit 3) - Change from baseline (i.e. decrease of score) | 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. |
| Primary | Change From Baseline in UPDRS Part III (Motor Examination) | Baseline and Final (visit 3) - Change from baseline (i.e. decrease of score) | 14 components rating scale with 27 items scored by 0 (none) - 4 (severe) |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part I (Mentation, Behaviour and Mood) | Baseline and Final (visit 3) - Change from baseline (i.e. decrease of score) | Only those patients of the full analysis set (FAS) with an evaluation of UPDRS Part I at visit 3 were included in this analysis | Points on a scale | MEDIAN |
| PRIMARY | Change From Baseline in Hospital Anxiety and Depression Scale - HADS-D Depression Subscore | Baseline and Final (visit 3) - Change from baseline (i.e. decrease of score) | Only those patients of the full analysis set (FAS) with an evaluation of HADS-D at visit 3 were included in this analysis | Points on a scale | MEDIAN |
| PRIMARY | Change From Baseline in Hospital Anxiety and Depression Scale - HADS-A Anxiety Subscore | Baseline and Final (visit 3) - Change from baseline (i.e. decrease of score) | Only those patients of the full analysis set (FAS) with an evaluation of HADS-A at visit 3 were included in this analysis | Points on a scale | MEDIAN |
| PRIMARY | Change From Baseline in UPDRS Part III (Motor Examination) | Baseline and Final (visit 3) - Change from baseline (i.e. decrease of score) | Only those patients of the full analysis set (FAS) with an evaluation of UPDRS Part III at visit 3 were included in this analysis | Points on a scale | MEDIAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part I (Mentation, Behaviour and Mood) | Early PD | 2 | Inter-Quartile Range 1.00 to 3.00 | Points on a scale | |
| Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part I (Mentation, Behaviour and Mood) | Advanced PD | 2 | Inter-Quartile Range 1.00 to 3.00 | Points on a scale | |
| Change From Baseline in Hospital Anxiety and Depression Scale - HADS-D Depression Subscore | Early PD | 3 | Inter-Quartile Range 1.00 to 6.00 | Points on a scale | |
| Change From Baseline in Hospital Anxiety and Depression Scale - HADS-D Depression Subscore | Advanced PD | 4 | Inter-Quartile Range 2.00 to 7.00 | Points on a scale | |
| Change From Baseline in Hospital Anxiety and Depression Scale - HADS-A Anxiety Subscore | Early PD | 2 | Inter-Quartile Range 1.00 to 4.00 | Points on a scale | |
| Change From Baseline in Hospital Anxiety and Depression Scale - HADS-A Anxiety Subscore | Advanced PD | 4 | Inter-Quartile Range 1.00 to 6.00 | Points on a scale | |
| Change From Baseline in UPDRS Part III (Motor Examination) | Early PD | 9 | Inter-Quartile Range 4.00 to 14.00 | Points on a scale | |
| Change From Baseline in UPDRS Part III (Motor Examination) | Advanced PD | 10 | Inter-Quartile Range 6.00 to 17.00 | Points on a scale |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Early (PD) | 189 | |
| Overall Study | STARTED | Advanced PD | 97 | |
| Overall Study | COMPLETED | Early (PD) | 169 | |
| Overall Study | COMPLETED | Advanced PD | 87 | |
| Overall Study | NOT COMPLETED | Early (PD) | 20 | |
| Overall Study | NOT COMPLETED | Advanced PD | 10 |
Source ClinicalTrials.gov
Adverse events2
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Pneumonia | Respiratory, thoracic and mediastinal disorders | Early PD | 0 | 189 | |
| serious | Pneumonia | Respiratory, thoracic and mediastinal disorders | Advanced PD | 1 | 97 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Early PD | ||
| Total, all-cause mortality | Advanced PD | ||
| Total, other adverse events | Early PD | 0 | 189 |
| Total, other adverse events | Advanced PD | 0 | 97 |
| Total, serious adverse events | Early PD | 0 | 189 |
| Total, serious adverse events | Advanced PD | 1 | 97 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Early PD vs Advanced PD: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00651183
GET https://conductscience.org/api/trials/v1/NCT00651183/registered