Buspirone in Parkinson's Disease

Phase 2

Completed

Conditions: Parkinson Disease
Anxiety

Interventions: Drug: Placebo
Drug: Buspirone

Registration Number: NCT02803749

Lead Sponsor: University of Rochester

Brief Summary: Anxiety is highly prevalent in Parkinson's disease and negatively impacts quality of life yet it frequently remains untreated and there have been no clinical trials dedicated to evaluating the pharmacological treatment of anxiety in Parkinson's disease. Buspirone is effective for the treatment of generalized anxiety disorder in the general and elderly population. It is not known if it is effective for the treatment of anxiety in Parkinson's disease. This is a single-center, placebo-controlled, double-blind design with participants randomized with a 4:1 allocation ratio to flexible dosage buspirone (maximum dosage 30 mg twice daily) or placebo for 12 weeks.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 21

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Flexible dosage placebo for 12 weeks.
Buspirone	Buspirone	Flexible dosage buspirone (maximum dosage 30 mg twice daily) for 12 weeks.

Primary Outcome Measures

Name	Time	Method
The Number of Participants Who Fail to Complete the 12-week Study on Study Drug.	12 weeks

Secondary Outcome Measures

Name	Time	Method
Number of Responders (>50% Reduction From Baseline or Reduction to ≤7 on HAM-A) at 12 Weeks	12 weeks	The HAM-A assess anxiety on 0-56 scale where a higher score represents a higher level of anxiety.
Mean Change in Hamilton Anxiety Rating Scale (HAM-A) From Baseline to 12 Weeks	12 weeks	The HAM-A assess anxiety on 0-56 scale where a higher score represents a higher level of anxiety.
Number of "Much Improved" or "Very Much Improved" on Patient Global Impressions-Improvement (PGI-I) at 12 Weeks	12 weeks	The PGI-I assesses patient global impression of improvement on a 7-point scale where 1 = "very much improved" and 7 = "very much worse."
Mean Change in Unified Dyskinesia Rating Scale (UDysRS) From Baseline to 12 Weeks	12 weeks	The UDysRS assesses dyskinesias on a scale of 0-104 where a higher score represents more severe dyskinesias.
Mean Change in Anxiety Using the Hospital Anxiety and Depression Scale (HADS)	baseline to 12 weeks	The HADS assesses anxiety on a scale of 0-21 and depression on a scale of 0-21 with higher scores indicating higher levels of anxiety and depression respectively.
Mean Change in Hospital Anxiety and Depression Scale (HADS) - Depression From Baseline to 12 Weeks	12 weeks	The HADS assesses anxiety on a scale of 0-21 and depression on a scale of 0-21 with higher scores indicating higher levels of anxiety and depression respectively.
Number of "Much Improved" or "Very Much Improved" on Clinical Global Impressions-Improvement (CGI-I) at 12 Weeks	12 weeks	The CGI-I assesses clinician global impression of improvement on a 7-point scale where 1 = "very much improved" and 7 = "very much worse."