Efficacy of BNC210 in Acute, As-needed Treatment of Anxiety in Social Anxiety Disorder - 1

Launched by BIONOMICS LIMITED · Jul 15, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a medication called BNC210 to see if it can help reduce anxiety in adults with Social Anxiety Disorder (SAD). Participants will take either BNC210 or a placebo (a pill with no active medication) and then take part in an activity designed to provoke anxiety. Researchers will measure how much anxiety the participants feel using a simple scale. The goal is to find out if BNC210 can effectively lessen anxiety during these stressful moments.

To be eligible for this trial, participants must have a current diagnosis of social anxiety disorder and score at least 60 on a specific anxiety scale. They should also be able to swallow tablets and use appropriate birth control if needed. However, individuals with certain mental health conditions, such as bipolar disorder or schizophrenia, and those who have recently used other psychiatric medications, may not qualify. If you join the trial, you will be closely monitored, and your safety and well-being will be prioritized throughout the study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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.