Ignite Creation Date:
2024-05-05 @ 4:42 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00297778
Status:
COMPLETED
Last Update Posted:
2014-06-09
First Post:
2006-02-28
Brief Title:
Pramipexole Versus Placebo in Parkinsons Disease PD Patients With Depressive Symptoms
Sponsor:
Boehringer Ingelheim
Organization:
Boehringer Ingelheim
Study Overview
Official Title:
A Randomized Double-blind Placebo-controlled Parallel Group Efficacy Study of Pramipexole and Placebo Administered Orally Over a 12 Week Treatment Phase in Parkinsons Disease Patients With Stable Motor Function and Depressive Symptoms
Status:
COMPLETED
Status Verified Date:
2014-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Parkinsons Disease PD is caused by a decrease of dopamine in a particular part of the brain Dopamine is a messenger substance neurotransmitter that is used by the cells of the brain nerve cells to control and harmonize muscle movements Consequently the main manifestations of the disease affect movement and include tremor muscular rigidity slowness in performing movements and loss of balance
However the disease affects also other non motor functions and may cause other disorders such as depression Depression may be a reaction to the disability caused by the disease but many studies show that depression is more common in PD than in other chronic debilitating illnesses Moreover there is also a biological explanation for the phenomenon dopamine is also used in brain circuits involved in the experience of pleasure and loss of pleasure in daily physical or social activity is one of the key manifestations of depression
The objective of the study is to assess whether pramipexole at doses approved for the treatment of PD symptoms is more effective than placebo in resolving depressive symptoms in PD patients
Also data on the safety of the product in the disease will be collected
However the disease affects also other non motor functions and may cause other disorders such as depression Depression may be a reaction to the disability caused by the disease but many studies show that depression is more common in PD than in other chronic debilitating illnesses Moreover there is also a biological explanation for the phenomenon dopamine is also used in brain circuits involved in the experience of pleasure and loss of pleasure in daily physical or social activity is one of the key manifestations of depression
The objective of the study is to assess whether pramipexole at doses approved for the treatment of PD symptoms is more effective than placebo in resolving depressive symptoms in PD patients
Also data on the safety of the product in the disease will be collected
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Eudract 2005-003788-22 | None | None | None |