Clinical trial NCT06510504: Efficacy of BNC210 in Acute, As-needed Treatment of Anxiety in Social Anxiety Disorder - 1
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Social Anxiety Disorder
Lead sponsor: Bionomics Limited
Sponsor class: INDUSTRY
First posted: 2024-07-19
Enrollment: 332
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: This is a randomized, double-blind, placebo-controlled, 2-arm, parallel-group, multi-center study. Participants will attend a Screening Visit to confirm eligibility and then return to the clinic within 21 days to be randomized into the study. Randomized participants will receive a single dose of their allocated study medication (225 mg BNC210 or placebo) and approximately 1 hour later participate in a behavioral assessment task. After 1 week, a safety follow-up assessment will be conducted by phone/video conference.

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.

Primary outcomes:
measure: Subjective Units of Distress Scale (SUDS)
timeFrame: 1 day
Secondary outcomes:
measure: Clinical Global Impressions-Severity (CGI-S)
timeFrame: 1 day
measure: Patient Global Impressions-Improvement (PGI-I)
timeFrame: 1 day
measure: State-Trait Anxiety Inventory (State Component; STAI-State)
timeFrame: 1 day
Other outcomes:
Locations:
city: Encino
country: United States
facility: AFFIRM-1 Study Site
state: California
city: La Jolla
country: United States
facility: AFFIRM-1 Study Site
state: California
city: Los Angeles
country: United States
facility: AFFIRM-1 Study Site
state: California
city: Oceanside
country: United States
facility: AFFIRM-1 Study Site
state: California
city: San Diego
country: United States
facility: AFFIRM-1 Study Site
state: California
city: San Jose
country: United States
facility: AFFIRM-1 Study Site
state: California
city: Sherman Oaks
country: United States
facility: AFFIRM-1 Study Site
state: California
city: Temecula
country: United States
facility: AFFIRM-1 Study Site
state: California
city: Jacksonville
country: United States
facility: AFFIRM-1 Study Site
state: Florida
city: Lauderhill
country: United States
facility: AFFIRM-1 Study Site
state: Florida
city: Miami Lakes
country: United States
facility: AFFIRM-1 Study Site
state: Florida
city: Orlando
country: United States
facility: AFFIRM-1 Study Site
state: Florida
city: Tampa
country: United States
facility: AFFIRM-1 Study Site
state: Florida
city: Decatur
country: United States
facility: AFFIRM-1 Study Site
state: Georgia
city: Boston
country: United States
facility: AFFIRM-1 Study Site
state: Massachusetts
city: Boston
country: United States
facility: AFFIRM-1 Study Site
state: Massachusetts
city: Princeton
country: United States
facility: AFFIRM-1 Study Site
state: New Jersey
city: Brooklyn
country: United States
facility: AFFIRM-1 Study Site
state: New York
city: Charlotte
country: United States
facility: AFFIRM-1 Study Site
state: North Carolina
city: Media
country: United States
facility: AFFIRM-1 Study Site
state: Pennsylvania
city: Austin
country: United States
facility: AFFIRM-1 Study Site
state: Texas
Study officials:
References: