RECRUITING

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

Description

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 the Subjective Units of Distress Scale (SUDS) in adult patients with social anxiety disorder.

Conditions

Social Anxiety Disorder
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Related Conditions:

Social Anxiety Disorder

Study Overview

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Study Details

Study overview

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 the Subjective Units of Distress Scale (SUDS) in adult patients with social anxiety disorder.

A Phase 3, Randomized, Double-blind, 2-arm, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy and Safety of BNC210 for the Acute, As-needed Treatment of Anxiety in Adults with Social Anxiety Disorder

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

Condition
Social Anxiety Disorder
Intervention / Treatment

-

Contacts and Locations

Encino

AFFIRM-1 Study Site, Encino, California, United States, 91316

Oceanside

AFFIRM-1 Study Site, Oceanside, California, United States, 92056

San Diego

AFFIRM-1 Study Site, San Diego, California, United States, 92103

San Jose

AFFIRM-1 Study Site, San Jose, California, United States, 95124

Sherman Oaks

AFFIRM-1 Study Site, Sherman Oaks, California, United States, 91403

Temecula

AFFIRM-1 Study Site, Temecula, California, United States, 92591

Jacksonville

AFFIRM-1 Study Site, Jacksonville, Florida, United States, 32256

Lauderhill

AFFIRM-1 Study Site, Lauderhill, Florida, United States, 33319

Miami Lakes

AFFIRM-1 Study Site, Miami Lakes, Florida, United States, 33016

Orlando

AFFIRM-1 Study Site, Orlando, Florida, United States, 32801

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to 65 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Bionomics Limited,

Study Record Dates

2025-09