Buspirone in Parkinson's Disease

Inclusion criteria

• Diagnosis of idiopathic PD by UK Parkinson's Disease Society Brain Bank Clinical Diagnostic Criteria
• Significant anxiety as determined by the self-rated Parkinson Anxiety Scale (score ≥ 14)
• Able to provide written informed consent
• At least 18 years of age

Exclusion criteria

• Diagnosis of atypical or secondary parkinsonism
• Concomitant treatment with an MAO inhibitor within the 14 days prior to screening visit
• Significant renal or hepatic impairment
• Significant cognitive impairment defined as MOCA score < 23
• On-going depression with suicidal or homicidal ideation and concern for patient safety based on clinical determination by the investigator
• Allergy or intolerance to study drug, matching placebo, or their formulations
• History of prior exposure to study drug
• Lactating or pregnant woman
• Concomitant treatment with a disallowed medication (detailed in section 6.2)
• Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements
• Concomitant treatment with an anxiolytic or antidepressant will be allowed however potential participants who had dosage changes in the 30 days prior to the screening visit will be excluded
• Use of an investigational drug within 30 days prior to screening visit
• Any medical or psychiatric comorbidity that, in the opinion of the investigator, would compromise study participation
• Dysphagia defined as a score of ≥ 2 on MDS-UPDRS Item 2.3 Chewing and Swallowing