Phase 2
N=151
A Phase 2 Study of BNC210 for the Acute Treatment of Social Anxiety Disorder
Social Anxiety Disorder
Bottom Line
View on ClinicalTrials.gov: NCT05193409 ↗Enrolled (actual)
151
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcome: Primary: Change From Baseline to the Average Subjective Units of Distress Scale (SUDS) Score of the 5-minute Performance Phase of a Public Speaking Challenge — 22.42; 24.26; 29.03 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- 225 mg BNC210 (Drug); 675 mg BNC210 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bionomics Limited
- Primary completion
- Oct 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to the Average Subjective Units of Distress Scale (SUDS) Score of the 5-minute Performance Phase of a Public Speaking Challenge |
22.42; 24.26; 29.03 | — |
| SECONDARY Change From Baseline to the Average SUDS Score of the 2-minute Anticipation Phase of a Public Speaking Challenge |
15.18; 12.86; 18.95 | — |
| SECONDARY Change From Baseline to the End of the 5-minute Performance Phase of Public Speaking Challenge in the State-Trait Anxiety Inventory (State Component; STAI-State) Score |
3.83; 3.04; 4.71 | — |
| SECONDARY Change From Baseline to the End of the 2-minute Anticipation Phase of Public Speaking Challenge in the STAI-State Score |
5.77; 5.45; 9.04 | — |
| SECONDARY Change From Baseline to the End of the 5-minute Performance Phase of Public Speaking Challenge in the Self Statements During Public Speaking - Negative Self Statements (SSPS-N) Score |
-1.54; -1.79; -0.77 | — |
| SECONDARY Change From Baseline to the End of the 2-minute Anticipation Phase of Public Speaking Challenge in the SSPS-N Score |
-0.38; -2.69; -1.25 | — |
Summary
The purpose of this study is to assess the effects of an acute dose of BNC210 compared to placebo on reducing anxiety provoked by a speaking challenge and measured using the Subjective Units of Distress Scale (SUDS) in patients with Social Anxiety Disorder (SAD).
Eligibility Criteria
Inclusion Criteria
- Participant has a current diagnosis of Social Anxiety Disorder (SAD) as defined in DSM-5 and confirmed by Structured Clinical Interview for DSM-5 Disorders - Clinical Trials version (SCID-5-CT).
- Liebowitz Social Anxiety Scale (LSAS) total score of ≥70
- Suitable contraception use in line with protocol requirements
- Ability to swallow tablets
Exclusion Criteria
- History of schizophrenia, bipolar disorder, or psychotic disorders, or has a current clinically predominant diagnosis of any other Axis I disorder, other than SAD
- Hamilton Rating Scale for Depression (HAM-D) score of ≥18
- Moderate or severe alcohol-use disorder, or any other substance-use disorder (any severity) in the past 12 months
- Use of psychotropic medications within 30 days of screening. Daily use of benzodiazepines within 90 days of screening.
- Previous participation in a study that involved a speaking challenge.
- Any clinically significant medical history or findings as determined by the Investigator that could interfere with the objectives of the study or put the participant at risk
Data sourced from ClinicalTrials.gov (NCT05193409). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.