Buspirone in Parkinson's Disease

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

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.

Study Overview

• Status: Completed
• Conditions: Parkinson Disease; Anxiety
• Intervention / Treatment: Drug: Placebo; Drug: Buspirone

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14618
      • University of Rochester Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University of Rochester
• Collaborators: Michael J. Fox Foundation for Parkinson's Research
• Investigators: Principal Investigator: Irene Richard, MD, University of Rochester

Study record dates

Study Major Dates

• Study Start: October 1, 2016
• Primary Completion (Actual): January 1, 2019
• Study Completion (Actual): January 25, 2019

Study Registration Dates

• First Submitted: June 14, 2016
• First Submitted That Met QC Criteria: June 14, 2016
• First Posted (Estimate): June 17, 2016

Study Record Updates

• Last Update Posted (Actual): January 2, 2020
• Last Update Submitted That Met QC Criteria: December 16, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Serotonin Receptor Agonists; Anti-Anxiety Agents; Buspirone
• Other Study ID Numbers: 61141

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No