Clinical trial NCT02803749: Buspirone in Parkinson's Disease
Official title: The Tolerability of Buspirone for the Treatment of Anxiety in Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Parkinson Disease
Anxiety
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: Michael J. Fox Foundation for Parkinson's Research
First posted: 2016-06-17
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: The Number of Participants Who Fail to Complete the 12-week Study on Study Drug.
timeFrame: 12 weeks
Secondary outcomes:
measure: Mean Change in Hamilton Anxiety Rating Scale (HAM-A) From Baseline to 12 Weeks
timeFrame: 12 weeks
measure: Number of Responders (>50% Reduction From Baseline or Reduction to ≤7 on HAM-A) at 12 Weeks
timeFrame: 12 weeks
measure: Number of "Much Improved" or "Very Much Improved" on Patient Global Impressions-Improvement (PGI-I) at 12 Weeks
timeFrame: 12 weeks
measure: Mean Change in Anxiety Using the Hospital Anxiety and Depression Scale (HADS)
timeFrame: baseline to 12 weeks
measure: Mean Change in Unified Dyskinesia Rating Scale (UDysRS) From Baseline to 12 Weeks
timeFrame: 12 weeks
measure: Number of "Much Improved" or "Very Much Improved" on Clinical Global Impressions-Improvement (CGI-I) at 12 Weeks
timeFrame: 12 weeks
measure: Mean Change in Hospital Anxiety and Depression Scale (HADS) - Depression From Baseline to 12 Weeks
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
Study officials:
affiliation: University of Rochester
name: Irene Richard, MD
role: PRINCIPAL_INVESTIGATOR
References: