COMPLETED

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-08-06

Study Completion:2025-09-19

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT06510504

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.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.

Inclusion Criteria

Exclusion 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.

Contacts and Locations

Study Locations (Sites)

AFFIRM-1 Study Site

Encino, California, 91316

United States

AFFIRM-1 Study Site

La Jolla, California, 92037

United States

AFFIRM-1 Study Site

Los Angeles, California, 90025

United States

AFFIRM-1 Study Site

Oceanside, California, 92056

United States

AFFIRM-1 Study Site

San Diego, California, 92103

United States

AFFIRM-1 Study Site

San Jose, California, 95124

United States

AFFIRM-1 Study Site

Sherman Oaks, California, 91403

United States

AFFIRM-1 Study Site

Temecula, California, 92591

United States

AFFIRM-1 Study Site

Jacksonville, Florida, 32256

United States

AFFIRM-1 Study Site

Lauderhill, Florida, 33319

United States

AFFIRM-1 Study Site

Miami Lakes, Florida, 33016

United States

AFFIRM-1 Study Site

Orlando, Florida, 32801

United States

AFFIRM-1 Study Site

Tampa, Florida, 33607

United States

AFFIRM-1 Study Site

Decatur, Georgia, 30030

United States

AFFIRM-1 Study Site

Boston, Massachusetts, 02114

United States

AFFIRM-1 Study Site

Boston, Massachusetts, 02131

United States

AFFIRM-1 Study Site

Princeton, New Jersey, 08540

United States

AFFIRM-1 Study Site

Brooklyn, New York, 11229

United States

AFFIRM-1 Study Site

Charlotte, North Carolina, 28211

United States

AFFIRM-1 Study Site

Media, Pennsylvania, 19063

United States

AFFIRM-1 Study Site

Austin, Texas, 78737

United States

Collaborators and Investigators

Sponsor: Bionomics Limited

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-06

Study Completion Date2025-09-19

Study Record Updates

Study Start Date2024-08-06

Study Completion Date2025-09-19

Terms related to this study

Additional Relevant MeSH Terms

Social Anxiety Disorder