Efficacy of BNC210 in Acute, As-needed Treatment of Anxiety in Social Anxiety Disorder - 1
- Conditions
- Social Anxiety Disorder
- Interventions
- Drug: 225 mg BNC210Drug: Placebo
- Registration Number
- NCT06510504
- Lead Sponsor
- Bionomics Limited
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 332
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 225 mg BNC210 225 mg BNC210 - Placebo Placebo -
- Primary Outcome Measures
Name Time Method Subjective Units of Distress Scale (SUDS) 1 day The Subjective Units of Distress Scale (SUDS) is a self reported measure of the intensity of distress currently experienced by an individual. The range is 0-100, with a higher score indicating a higher level of anxiety/greater distress.
- Secondary Outcome Measures
Name Time Method Clinical Global Impressions-Severity (CGI-S) 1 day The CGI-S measures overall disease severity of the participant's symptoms as scored by a clinician. Severity is rated from 1 (normal, not at all ill) to 7 (among the most extremely ill of patients) with a higher score indicating a higher level of disease severity.
Patient Global Impressions-Improvement (PGI-I) 1 day The PGI-I is a patient self-reported counterpart of the CGI designed to assess the patient's impression of their perceived change in overall symptoms. Improvement is rated from 1 (very much improved) to 7 (very much worse) with a higher score indicating a higher level of disease severity.
State-Trait Anxiety Inventory (State Component; STAI-State) 1 day The State-Trait Anxiety Inventory (State component; STAI-State) is a self reported measure of subjective anxiety at the time of questionnaire completion. The range is 0-80 with a higher total score indicating a higher level of anxiety.
Trial Locations
- Locations (1)
AFFIRM-1 Study Site
🇺🇸Austin, Texas, United States