Buspirone in Parkinson's Disease

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02803749
• Other study ID #: 61141
• Status: Completed
• Phase: Phase 2
• Start date: October 2016
• Est. completion date: January 25, 2019

Study information

• Verified date: December 2019
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: January 25, 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Parkinson Disease

Intervention

Drug:
• Buspirone

• Placebo

Locations

Country	Name	City	State
United States	University of Rochester Medical Center	Rochester	New York

Sponsors (2)

Lead Sponsor	Collaborator
University of Rochester	Michael J. Fox Foundation for Parkinson's Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Number of Participants Who Fail to Complete the 12-week Study on Study Drug.		12 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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