The Tolerability of Buspirone for the Treatment of Anxiety in Parkinson’s Disease

Study Rationale:                             
Anxiety is a common non-motor symptom among individuals with Parkinson’s disease (PD) and is associated with a reduced quality of life. Despite this, anxiety is under-treated and there have been no clinical trials specifically examining the pharmacological treatment of anxiety in PD.  Buspirone, a medication used to treat some forms of anxiety in the general population, may be effective for the treatment of anxiety in Parkinson’s. While buspirone has the additional potential benefit of reducing levodopa-induced dyskinesias, there are concerns that it could worsen motor function. 

Hypothesis:
The primary objective of this clinical trial is to determine the tolerability of buspirone for the treatment of anxiety in Parkinson’s.

Study Design:
This is a single-center, placebo-controlled trial in which participants will be randomly assigned to receive either a flexible dosage of buspirone or placebo for 12 weeks. Participants and investigators will be blinded to treatment assignment. Participants will return for visits at 2 weeks, 4 weeks,
8 weeks and 12 weeks, and telephone assessments will occur at 6 weeks and 10 weeks. Tolerability, side effects, anxiety, Parkinson’s disease motor function and dyskinesias will be evaluated.

Impact on Diagnosis/Treatment of Parkinson’s Disease:                              
We hope to identify effective treatments for anxiety in Parkinson’s disease, which could improve quality of life.

Next Steps for Development:
Pending the results of this trial, we will advance to Phase III testing to examine the effect of buspirone on anxiety in Parkinson’s disease.

Trial Phase: II