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CompletedNCT02803749Updated Jan 2, 2020Results posted

Buspirone in Parkinson's Disease

A Phase 2 interventional study of Buspirone and Placebo in Parkinson Disease and Anxiety, sponsored by University of Rochester. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-01-02.

Sponsored by University of Rochester · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
21
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Parkinson Disease
  • Anxiety
03

In context

Parkinson Disease

4,583 studies on the registry are indexed under Parkinson Disease; 1,097 are open to participants now.

This study's enrollment of 21 is below the median of 40 across 3,365 interventional studies indexed under Parkinson Disease.

Browse Parkinson Disease studies →

Lead sponsor

University of Rochester is the lead sponsor of 728 studies on the registry; 115 are open to participants now.

Of its 56 completed or terminated interventional studies of FDA-regulated products, 44 (79%) have results posted.

Browse University of Rochester studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
21 participants (actual)

Study arms

  • 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

Interventions

06

What researchers measure

Primary outcomes

  1. The Number of Participants Who Fail to Complete the 12-week Study on Study Drug.

    Time frame: 12 weeks

Secondary outcomes

  1. 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.

    Time frame: 12 weeks

  2. 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.

    Time frame: 12 weeks

  3. 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."

    Time frame: 12 weeks

  4. 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.

    Time frame: baseline to 12 weeks

  5. 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.

    Time frame: 12 weeks

  6. 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."

    Time frame: 12 weeks

  7. 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.

    Time frame: 12 weeks

07

Results

Posted Jan 2, 2020

Participant flow

Participant flow — Overall Study
MilestoneBuspironePlacebo
Started174
Completed124
Not completed50

Outcome measures

PrimaryThe Number of Participants Who Fail to Complete the 12-week Study on Study Drug.
Time frame:
12 weeks
Reported as:
Count of participants · Participants
The Number of Participants Who Fail to Complete the 12-week Study on Study Drug.
ParticipantsBuspironePlacebo
The Number of Participants Who Fail to Complete the 12-week Study on Study Drug.70
SecondaryMean 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.

Time frame:
12 weeks
Reported as:
Mean · score on a scale
Mean Change in Hamilton Anxiety Rating Scale (HAM-A) From Baseline to 12 Weeks
score on a scaleBuspironePlacebo
Mean Change in Hamilton Anxiety Rating Scale (HAM-A) From Baseline to 12 Weeks-4.21 ± 1.13-3.36 ± 1.97
SecondaryNumber 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.

Time frame:
12 weeks
Reported as:
Count of participants · Participants
Number of Responders (>50% Reduction From Baseline or Reduction to ≤7 on HAM-A) at 12 Weeks
ParticipantsBuspironePlacebo
Number of Responders (>50% Reduction From Baseline or Reduction to ≤7 on HAM-A) at 12 Weeks91
SecondaryNumber 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."

Time frame:
12 weeks
Reported as:
Count of participants · Participants
Number of "Much Improved" or "Very Much Improved" on Patient Global Impressions-Improvement (PGI-I) at 12 Weeks
ParticipantsBuspironePlacebo
Number of "Much Improved" or "Very Much Improved" on Patient Global Impressions-Improvement (PGI-I) at 12 Weeks30
SecondaryMean 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.

Time frame:
baseline to 12 weeks
Reported as:
Mean · score on a scale
Mean Change in Anxiety Using the Hospital Anxiety and Depression Scale (HADS)
score on a scaleBuspironePlacebo
Mean Change in Anxiety Using the Hospital Anxiety and Depression Scale (HADS)-1.87 ± 0.98-0.89 ± 1.71
SecondaryMean 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.

Time frame:
12 weeks
Reported as:
Mean · score on a scale
Mean Change in Unified Dyskinesia Rating Scale (UDysRS) From Baseline to 12 Weeks
score on a scaleBuspironePlacebo
Mean Change in Unified Dyskinesia Rating Scale (UDysRS) From Baseline to 12 Weeks.72 ± 3.227.78 ± 6.44
SecondaryNumber 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."

Time frame:
12 weeks
Reported as:
Count of participants · Participants
Number of "Much Improved" or "Very Much Improved" on Clinical Global Impressions-Improvement (CGI-I) at 12 Weeks
ParticipantsBuspironePlacebo
Number of "Much Improved" or "Very Much Improved" on Clinical Global Impressions-Improvement (CGI-I) at 12 Weeks52
SecondaryMean 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.

Time frame:
12 weeks
Reported as:
Mean · units on a scale
Mean Change in Hospital Anxiety and Depression Scale (HADS) - Depression From Baseline to 12 Weeks
units on a scaleBuspironePlacebo
Mean Change in Hospital Anxiety and Depression Scale (HADS) - Depression From Baseline to 12 Weeks-.95 ± .46.34 ± .81

Adverse events

Collected over 12 weeks. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Buspirone0/17 (0%)0/17 (0%)5/17 (29.4%)
Placebo0/4 (0%)0/4 (0%)3/4 (75%)
Most frequent other events
Showing 10 of 37
Most frequent other events
EventBuspironePlacebo
increased tremorGeneral disorders1/173/4
sleep difficultiesGeneral disorders2/172/4
balance impairmentGeneral disorders1/172/4
Increased freezing of gaitGeneral disorders5/170/4
increased peripheral edemaGeneral disorders1/171/4
RashSkin and subcutaneous tissue disorders1/171/4
FallInjury, poisoning and procedural complications0/171/4
Gait DifficultiesGeneral disorders0/171/4
VertigoGeneral disorders0/171/4
Vision ChangesEye disorders0/171/4

Baseline characteristics

Age, Continuous
Age, Continuous(years)BuspironePlaceboTotal
Mean65.5 ± 9.870.3 ± 10.666.4 ± 9.9
Sex: Female, Male
Sex: Female, Male(Participants)BuspironePlaceboTotal
Female437
Male13114
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)BuspironePlaceboTotal
Hispanic or Latino101
Not Hispanic or Latino16420
Unknown or Not Reported000
Region of Enrollment
Region of Enrollment(participants)BuspironePlaceboTotal
United States17421
Married participants
Married participants(Participants)BuspironePlaceboTotal
Count of participants14418
Greater than high school education
Greater than high school education(Participants)BuspironePlaceboTotal
Count of participants14418
History of Depression
History of Depression(Participants)BuspironePlaceboTotal
Count of participants213
Taking Antidepressant or Anxiolytic
Taking Antidepressant or Anxiolytic(Participants)BuspironePlaceboTotal
Count of participants15217

9 further baseline measures are reported on the registry.

08

Study locations

1 site
  • University of Rochester Medical Center
    Rochester, New York 14618, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · May 27, 2016
  • Informed consent form · Jun 9, 2016

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 2, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02803749
Lead sponsor
University of Rochester
Collaborators
Michael J. Fox Foundation for Parkinson's Research
Responsible party
Irene Richard (Professor of Neurology, University of Rochester) — Principal investigator
First posted
Jun 17, 2016
Start date
Oct 2016
Primary completion
Jan 2019
Completion
Jan 25, 2019
Results posted
Jan 2, 2020
Last update
Jan 2, 2020

Study contacts

Irene Richard, MD
principal investigator · University of Rochester

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.

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