Status:
COMPLETED
A Phase 2 Study of BNC210 for the Acute Treatment of Social Anxiety Disorder
Lead Sponsor:
Bionomics Limited
Conditions:
Social Anxiety Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief 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 Distre...
Detailed Description
This is a randomized, double-blind, placebo-controlled, 3-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
- 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
- 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
Key Trial Info
Start Date :
February 2 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 17 2022
Estimated Enrollment :
151 Patients enrolled
Trial Details
Trial ID
NCT05193409
Start Date
February 2 2022
End Date
October 17 2022
Last Update
March 18 2025
Active Locations (15)
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1
PREVAIL Study Clinical Trial Site
Beverly Hills, California, United States, 90210
2
PREVAIL Study Clinical Trial Site
Encino, California, United States, 91316
3
PREVAIL Study Clinical Trial Site
Glendale, California, United States, 91204
4
PREVAIL Study Clinical Trial Site
New Haven, Connecticut, United States, 33122