Is Pramipexole Safe and Effective in Reducing Depressive Symptoms in Patients with Mild to Moderate Parkinson’s Disease and Depression?

OBJECTIVE: The objective of this selective EBM review is to determine whether or not pramipexole (Mirapex) is a safe and effective drug to treat depression in patients with mild to moderate Parkinson’s Disease (PD). STUDY DESIGN: Review of three English language primary randomized controlled trials and one randomized prospective, observational study published between 2003-2010. DATA SOURCES: Three randomized controlled trials and one randomized prospective, observational study comparing the efficacy of pramipexole to placebo, sertraline (an SSRI) and other dopamine agonists (pergolide) in the treatment of PD related depression symptoms were found using PubMed. OUTCOME(S) MEASURED: Each of the four clinical trials assessed the improvement of depression in PD patients. In addition, they noted how the improvement in mood would impact patient\u27s quality of life. Prior to the study, all patients received an evaluation of the severity of their depressive symptoms in order to get a baseline level; this allowed researchers to note patient\u27s percent change from baseline. This was done through objective evaluation, as well as self-reported questionnaires. Patients were evaluated for disease severity, quality of life, motor functioning, psychopathology, activities of daily living and depression severity. RESULTS: Three randomized-controlled trials and one randomized prospective, observational study were included in this review. Results from each study reveals that pramipexole is a safe and effective drug to treat depression in mild to moderate PD patients. Pramipexole was found to be more effective than placebo, similar in efficacy to pergolide and sertraline, but with less adverse reactions than sertraline. The patients’ quality of life also improved due to the reduction in motor symptoms that pramipexole is currently FDA approved to treat. CONCLUSION: The four clinical trials included in this review have shown that pramipexole is a safe and effective treatment for depression in PD patients. Pramipexole is currently not approved for use to treat depression in PD and although initial studies are promising, further evaluation is necessary. In addition the FDA is currently investigating an association between pramipexole and increased risk of heart failure