Pramipexole Versus Placebo in Parkinson's Disease (PD) Patients With Depressive Symptoms
Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
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.