Social Anxiety Disorder
Conditions
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.
Interventions
DRUG225 mg BNC210
225 mg BNC210
DRUGPlacebo
Placebo
Sponsors
Bionomics Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to the Average Subjective Units of Distress Scale (SUDS) Score of the 5-minute Performance Phase of a Public Speaking Challenge | Assessed over a single visit: On the treatment day at Baseline (approximately 5 minutes pre-dose) and during the Public Speaking Challenge Performance Phase conducted at 65 to 70 minutes post-dose (following the Anticipation Phase that started at 60 min). | The 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
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to the Average SUDS Score of the 2-minute Anticipation Phase of a Public Speaking Challenge | Assessed over a single visit: On the treatment day at Baseline (approximately 5 minutes pre-dose) and during the Public Speaking Challenge Anticipation Phase conducted at 60 to 62 minutes post-dose (the first 2 minutes of the Public Speaking Challenge). | The 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. |
| Change From Baseline to the End of the 5-minute Performance Phase of a Public Speaking Challenge in the Clinical Global Impressions-Severity (CGI-S) Score | Assessed over a single visit: On the treatment day at Baseline (approximately 5 minutes pre-dose) and at the end of the Public Speaking Challenge Performance Phase at 70 minutes post-dose (following the Anticipation Phase that started at 60 min). | 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. |
| Difference at the End of the 5-minute Performance Phase of a Public Speaking Challenge in the Patient Global Impressions-Improvement (PGI-I) Score | Assessed over a single visit: On the treatment day at the end of the Public Speaking Challenge Performance Phase at 70 minutes post-dose (following the Anticipation Phase that started at 60 min). | 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. |
| Change From Baseline to the End of the 5-minute Performance Phase of a Public Speaking Challenge in the State-Trait Anxiety Inventory (State Component; STAI-State) Score | Assessed over a single visit: On the treatment day at Baseline (approximately 5 minutes pre-dose) and at the end of the Public Speaking Challenge Performance Phase at 70 minutes post-dose (following the Anticipation Phase that started at 60 min). | 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. |
Countries
United States
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 36 Years STANDARD_DEVIATION 12.36 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 34 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 142 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Liebowitz Social Anxiety Scale (LSAS) | 95.2 units on a scale STANDARD_DEVIATION 16.96 |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants |
| Race (NIH/OMB) Asian | 68 Participants |
| Race (NIH/OMB) Black or African American | 40 Participants |
| Race (NIH/OMB) More than one race | 20 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) White | 189 Participants |
| Sex: Female, Male Female | 112 Participants |
| Sex: Female, Male Male | 65 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 183 | 0 / 184 |
| other Total, other adverse events | 23 / 183 | 9 / 184 |
| serious Total, serious adverse events | 0 / 183 | 0 / 184 |
Outcome results
None listed