Status:
COMPLETED
Efficacy of BNC210 in Acute, As-needed Treatment of Anxiety in Social Anxiety Disorder - 1
Lead Sponsor:
Bionomics Limited
Conditions:
Social Anxiety Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
The purpose of the study is to evaluate the effect of a single, acute dose of BNC210 compared to placebo on reducing the severity of anxiety provoked by a behavioral assessment task and measured using...
Detailed Description
This is a randomized, double-blind, placebo-controlled, 2-arm, parallel-group, multi-center study. Participants will attend a Screening Visit to confirm eligibility and then return to the clinic withi...
Eligibility Criteria
Inclusion
- A current diagnosis of social anxiety disorder as defined in the DSM-5.
- A Liebowitz Social Anxiety Scale total score of ≥60.
- Suitable contraception use in line with protocol requirements.
- Ability to swallow tablets.
Exclusion
- History of bipolar disorder, schizophrenia, schizoaffective disorder, psychotic disorders, anorexia or bulimia, body dysmorphic disorder, PTSD, autism-spectrum disorder or obsessive-compulsive disorder, or any other Axis I or II disorder which is currently the primary focus of treatment over social anxiety disorder.
- Hamilton Rating Scale for Depression 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.
- 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.
Key Trial Info
Start Date :
August 6 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 19 2025
Estimated Enrollment :
370 Patients enrolled
Trial Details
Trial ID
NCT06510504
Start Date
August 6 2024
End Date
September 19 2025
Last Update
October 24 2025
Active Locations (21)
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1
AFFIRM-1 Study Site
Encino, California, United States, 91316
2
AFFIRM-1 Study Site
La Jolla, California, United States, 92037
3
AFFIRM-1 Study Site
Los Angeles, California, United States, 90025
4
AFFIRM-1 Study Site
Oceanside, California, United States, 92056