A Phase 2 Study of BNC210 for the Acute Treatment of Social Anxiety Disorder

• Status: Recruiting
• Trial end date: 2022-11-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bionomics Limited

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