Buspirone in Parkinson's Disease

Study Overview
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Brief Summary
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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.

Official Title
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The Tolerability of Buspirone for the Treatment of Anxiety in Parkinson's Disease

Conditions
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Parkinson Disease, Anxiety

Intervention / Treatment
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* Drug: Buspirone
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Buspirone<br>Flexible dosage buspirone (maximum dosage 30 mg twice daily) for 12 weeks. | Drug: Buspirone<br> <br> |
| Placebo Comparator: Placebo<br>Flexible dosage placebo for 12 weeks. | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Number of Participants Who Fail to Complete the 12-week Study on Study Drug. |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change in Hamilton Anxiety Rating Scale (HAM-A) From Baseline to 12 Weeks | The HAM-A assess anxiety on 0-56 scale where a higher score represents a higher level of anxiety. | 12 weeks | 
| Number of Responders (>50% Reduction From Baseline or Reduction to ≤7 on HAM-A) at 12 Weeks | The HAM-A assess anxiety on 0-56 scale where a higher score represents a higher level of anxiety. | 12 weeks | 
| Number of Much Improved or Very Much Improved on Patient Global Impressions-Improvement (PGI-I) at 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. | 12 weeks | 
| Mean Change in Anxiety Using the Hospital Anxiety and Depression Scale (HADS) | 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. | baseline to 12 weeks | 
| Mean Change in Unified Dyskinesia Rating Scale (UDysRS) From Baseline to 12 Weeks | The UDysRS assesses dyskinesias on a scale of 0-104 where a higher score represents more severe dyskinesias. | 12 weeks | 
| Number of Much Improved or Very Much Improved on Clinical Global Impressions-Improvement (CGI-I) at 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. | 12 weeks | 
| Mean Change in Hospital Anxiety and Depression Scale (HADS) - Depression From 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. | 12 weeks |