Trial · NCT03017508
Acute Anxiolytic Effects of Riluzole on Subjects With Social Anxiety Disorder
NCT03017508, Phase 2, Phase 3, Completed, Yale University; results first posted 2021-05-20
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Acute Anxiolytic Effects of Riluzole on Subjects With Social Anxiety Disorder. Trials, record NCT03017508. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03017508
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Acute Anxiolytic Effects of Riluzole on Subjects With Social Anxiety Disorder
- NCT number
- NCT03017508
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 22 participants, actual
- Lead sponsor
- Yale University
- Conditions
- Social Anxiety Disorder, Performance Anxiety
- Interventions
- BHV-0223, Placebo
- First posted
- 2017-01-11
- Last updated
- 2021-05-20
- Results first posted
- 2021-05-20
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | VAS-anxiety Immediately After the Impromptu Speech Task | up to 60 minutes | Measure Description: In the Visual Analogue Scale (VAS) participants are presented with a straight horizontal line of 100 mm in length and asked to mark the placement that would best describe the intensity of the anxiety felt at that moment. The left end (0mm) represents "no anxiety" and the right end (100mm) represents "the worst anxiety ever felt" by the participant.The VAS score is determined by measuring in millimeters from the left hand end of the line to the point that the patient marks, generating a numerical score along a continuum |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | VAS-anxiety Immediately After the Impromptu Speech Task | up to 60 minutes | millimeters (units on a scale) | MEAN |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| VAS-anxiety Immediately After the Impromptu Speech Task | BHV-0223 (Sublingual Riluzole) | 54.3 | Standard Deviation 23.6 | millimeters (units on a scale) | |
| VAS-anxiety Immediately After the Impromptu Speech Task | Placebo | 62.6 | Standard Deviation 13.7 | millimeters (units on a scale) |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Participants Randomized to BHV-0223 First and After a Washout Period of 2-10 Days Received Placebo | 12 | |
| Overall Study | STARTED | Participants Randomized to Placebo First and After a Washout Period of 2-10 Days Received BHV-0223 | 10 | |
| Overall Study | First Intervention (1 Day) | Participants Randomized to BHV-0223 First and After a Washout Period of 2-10 Days Received Placebo | 12 | |
| Overall Study | First Intervention (1 Day) | Participants Randomized to Placebo First and After a Washout Period of 2-10 Days Received BHV-0223 | 10 | |
| Overall Study | Washout (2-10 Days) | Participants Randomized to BHV-0223 First and After a Washout Period of 2-10 Days Received Placebo | 12 | |
| Overall Study | Washout (2-10 Days) | Participants Randomized to Placebo First and After a Washout Period of 2-10 Days Received BHV-0223 | 10 | |
| Overall Study | Second Intervention (1 Day) | Participants Randomized to BHV-0223 First and After a Washout Period of 2-10 Days Received Placebo | 12 | |
| Overall Study | Second Intervention (1 Day) | Participants Randomized to Placebo First and After a Washout Period of 2-10 Days Received BHV-0223 | 10 | |
| Overall Study | COMPLETED | Participants Randomized to BHV-0223 First and After a Washout Period of 2-10 Days Received Placebo | 12 | |
| Overall Study | COMPLETED | Participants Randomized to Placebo First and After a Washout Period of 2-10 Days Received BHV-0223 | 10 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events2
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 | Temporary perioral numbing | General disorders | BHV-0223 (Sublingual Riluzole) | 13 | 22 | 13 |
| other | Temporary perioral numbing | General disorders | Placebo | 0 | 22 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | BHV-0223 (Sublingual Riluzole) | 0 | 22 |
| Total, all-cause mortality | Placebo | 0 | 22 |
| Total, other adverse events | BHV-0223 (Sublingual Riluzole) | 13 | 22 |
| Total, other adverse events | Placebo | 0 | 22 |
| Total, serious adverse events | BHV-0223 (Sublingual Riluzole) | 0 | 22 |
| Total, serious adverse events | Placebo | 0 | 22 |
Source ClinicalTrials.gov
Papers6
The papers the trial lists on ClinicalTrials.gov.
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| BHV-0223 (Sublingual Riluzole) vs Placebo: deaths from any cause | Trial comparisons |
| BHV-0223 (Sublingual Riluzole) 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/NCT03017508
GET https://conductscience.org/api/trials/v1/NCT03017508/registered