Trial · NCT02803749
Buspirone in Parkinson's Disease
NCT02803749, Phase 2, Completed, University of Rochester; results first posted 2020-01-02
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Buspirone in Parkinson's Disease. Trials, record NCT02803749. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02803749
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Buspirone in Parkinson's Disease
- NCT number
- NCT02803749
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 21 participants, actual
- Lead sponsor
- University of Rochester
- Conditions
- Parkinson Disease, Anxiety
- Interventions
- Buspirone, Placebo
- First posted
- 2016-06-17
- Last updated
- 2020-01-02
- Results first posted
- 2020-01-02
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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 | 12 weeks | The HAM-A assess anxiety on 0-56 scale where a higher score represents a higher level of anxiety. |
| Secondary | Number of Responders (>50% Reduction From Baseline or Reduction to ≤7 on HAM-A) at 12 Weeks | 12 weeks | The HAM-A assess anxiety on 0-56 scale where a higher score represents a higher level of anxiety. |
| Secondary | Number of "Much Improved" or "Very Much Improved" on Patient Global Impressions-Improvement (PGI-I) at 12 Weeks | 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." |
| Secondary | Mean Change in Anxiety Using the Hospital Anxiety and Depression Scale (HADS) | 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. |
| Secondary | Mean Change in Unified Dyskinesia Rating Scale (UDysRS) From Baseline to 12 Weeks | 12 weeks | The UDysRS assesses dyskinesias on a scale of 0-104 where a higher score represents more severe dyskinesias. |
| Secondary | Number of "Much Improved" or "Very Much Improved" on Clinical Global Impressions-Improvement (CGI-I) at 12 Weeks | 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." |
| Secondary | Mean Change in Hospital Anxiety and Depression Scale (HADS) - Depression From Baseline to 12 Weeks | 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. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Number of Participants Who Fail to Complete the 12-week Study on Study Drug. | 12 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Mean Change in Hamilton Anxiety Rating Scale (HAM-A) From Baseline to 12 Weeks | 12 weeks | score on a scale | MEAN | |
| SECONDARY | Number of Responders (>50% Reduction From Baseline or Reduction to ≤7 on HAM-A) at 12 Weeks | 12 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Much Improved or Very Much Improved on Patient Global Impressions-Improvement (PGI-I) at 12 Weeks | 12 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Mean Change in Anxiety Using the Hospital Anxiety and Depression Scale (HADS) | baseline to 12 weeks | score on a scale | MEAN | |
| SECONDARY | Mean Change in Unified Dyskinesia Rating Scale (UDysRS) From Baseline to 12 Weeks | 12 weeks | score on a scale | MEAN | |
| SECONDARY | Number of Much Improved or Very Much Improved on Clinical Global Impressions-Improvement (CGI-I) at 12 Weeks | 12 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Mean Change in Hospital Anxiety and Depression Scale (HADS) - Depression From Baseline to 12 Weeks | 12 weeks | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Number of Participants Who Fail to Complete the 12-week Study on Study Drug. | Buspirone | 7 | Participants | ||
| The Number of Participants Who Fail to Complete the 12-week Study on Study Drug. | Placebo | 0 | Participants | ||
| Mean Change in Hamilton Anxiety Rating Scale (HAM-A) From Baseline to 12 Weeks | Buspirone | -4.21 | Standard Error 1.13 | score on a scale | |
| Mean Change in Hamilton Anxiety Rating Scale (HAM-A) From Baseline to 12 Weeks | Placebo | -3.36 | Standard Error 1.97 | score on a scale | |
| Number of Responders (>50% Reduction From Baseline or Reduction to ≤7 on HAM-A) at 12 Weeks | Buspirone | 9 | Participants | ||
| Number of Responders (>50% Reduction From Baseline or Reduction to ≤7 on HAM-A) at 12 Weeks | Placebo | 1 | Participants | ||
| Number of Much Improved or Very Much Improved on Patient Global Impressions-Improvement (PGI-I) at 12 Weeks | Buspirone | 3 | Participants | ||
| Number of Much Improved or Very Much Improved on Patient Global Impressions-Improvement (PGI-I) at 12 Weeks | Placebo | 0 | Participants | ||
| Mean Change in Anxiety Using the Hospital Anxiety and Depression Scale (HADS) | Buspirone | -1.87 | Standard Error 0.98 | score on a scale | |
| Mean Change in Anxiety Using the Hospital Anxiety and Depression Scale (HADS) | Placebo | -0.89 | Standard Error 1.71 | score on a scale |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Buspirone | 17 | |
| Overall Study | STARTED | Placebo | 4 | |
| Overall Study | COMPLETED | Buspirone | 12 | |
| Overall Study | COMPLETED | Placebo | 4 | |
| Overall Study | NOT COMPLETED | Buspirone | 5 | |
| Overall Study | NOT COMPLETED | Placebo | 0 |
Source ClinicalTrials.gov
Adverse events74
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Increased freezing of gait | General disorders | Buspirone | 5 | 17 | |
| other | Increased freezing of gait | General disorders | Placebo | 0 | 4 | |
| other | tremor | General disorders | Buspirone | 3 | 17 | |
| other | tremor | General disorders | Placebo | 0 | 4 | |
| other | sleep difficulties | General disorders | Buspirone | 2 | 17 | |
| other | sleep difficulties | General disorders | Placebo | 2 | 4 | |
| other | dizziness | General disorders | Buspirone | 2 | 17 | |
| other | dizziness | General disorders | Placebo | 0 | 4 | |
| other | increased fatigue | General disorders | Buspirone | 2 | 17 | |
| other | increased fatigue | General disorders | Placebo | 0 | 4 |
1 to 10 of 74Source ClinicalTrials.gov
See all 74 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Buspirone | 0 | 17 |
| Total, all-cause mortality | Placebo | 0 | 4 |
| Total, other adverse events | Buspirone | 5 | 17 |
| Total, other adverse events | Placebo | 3 | 4 |
| Total, serious adverse events | Buspirone | 0 | 17 |
| Total, serious adverse events | Placebo | 0 | 4 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons6
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Buspirone vs Placebo: Number of Much Improved or Very Much Improved on Clinical Global Impressions-Improvement (CGI-I) at 12 Weeks | Trial comparisons |
| Buspirone vs Placebo: Number of Responders (>50% Reduction From Baseline or Reduction to ≤7 on HAM-A) at 12 Weeks | Trial comparisons |
| Buspirone vs Placebo: Number of Much Improved or Very Much Improved on Patient Global Impressions-Improvement (PGI-I) at 12 Weeks | Trial comparisons |
| Buspirone vs Placebo: The Number of Participants Who Fail to Complete the 12-week Study on Study Drug. | Trial comparisons |
| Buspirone vs Placebo: deaths from any cause | Trial comparisons |
| Buspirone vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02803749
GET https://conductscience.org/api/trials/v1/NCT02803749/events?page=2