Social Anxiety Disorder
Conditions
Brief summary
The purpose of this study is to assess the effects of an acute dose of BNC210 compared to placebo on reducing anxiety provoked by a speaking challenge and measured using the Subjective Units of Distress Scale (SUDS) in patients with Social Anxiety Disorder (SAD).
Detailed description
This is a randomized, double-blind, placebo-controlled, 3-arm, parallel-group, multi-center study. Participants will attend a Screening Visit to confirm eligibility and then return to the clinic within 14 days to be randomized into the study. Randomized participants will receive a single dose of their allocated study intervention (225 mg BNC210, 675 mg BNC210 or placebo) and approximately 1 hour later participate in a speaking challenge. After 1 week, a safety follow-up assessment will be conducted by phone/video conference.
Interventions
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
* Participant has a current diagnosis of Social Anxiety Disorder (SAD) as defined in DSM-5 and confirmed by Structured Clinical Interview for DSM-5 Disorders - Clinical Trials version (SCID-5-CT). * Liebowitz Social Anxiety Scale (LSAS) total score of ≥70 * Suitable contraception use in line with protocol requirements * Ability to swallow tablets
Exclusion criteria
* History of schizophrenia, bipolar disorder, or psychotic disorders, or has a current clinically predominant diagnosis of any other Axis I disorder, other than SAD * Hamilton Rating Scale for Depression (HAM-D) 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. * Previous participation in a study that involved a speaking challenge. * 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: Baseline; and the Performance Phase (0,1,2,3,4,5 minutes) of the Public Speaking Challenge, conducted 1 hour post-dose. | 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: Baseline; and the Anticipation Phase (0,1,2 minutes) of the Public Speaking Challenge, conducted 1 hour post-dose. | 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 Public Speaking Challenge in the State-Trait Anxiety Inventory (State Component; STAI-State) Score | Assessed over a single visit: Baseline; and the Performance Phase (5 minutes) of the Public Speaking Challenge, conducted 1 hour post-dose. | The 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. |
| Change From Baseline to the End of the 2-minute Anticipation Phase of Public Speaking Challenge in the STAI-State Score | Assessed over a single visit: Baseline; and the Anticipation Phase (2 minutes) of the Public Speaking Challenge, conducted 1 hour post-dose. | The 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. |
| Change From Baseline to the End of the 5-minute Performance Phase of Public Speaking Challenge in the Self Statements During Public Speaking - Negative Self Statements (SSPS-N) Score | Assessed over a single visit: Baseline; and the Performance Phase (5 minutes) of the Public Speaking Challenge, conducted 1 hour post-dose. | The SSPS-N is a self reported measure that assesses cognitions related to public speaking.The range is 0-25 with a higher total score indicating a higher level of negative cognitions. |
| Change From Baseline to the End of the 2-minute Anticipation Phase of Public Speaking Challenge in the SSPS-N Score | Assessed over a single visit: Baseline; and the Anticipation Phase (2 minutes) of the Public Speaking Challenge, conducted 1 hour post-dose. | The SSPS-N is a self reported measure that assesses cognitions related to public speaking.The range is 0-25 with a higher total score indicating a higher level of negative cognitions. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 225 mg BNC210 225 mg BNC210 tablet single dose | 50 |
| 675 mg BNC210 675 mg BNC210 tablet single dose | 51 |
| Placebo Placebo tablet single dose | 50 |
| Total | 151 |
Baseline characteristics
| Characteristic | Total | 675 mg BNC210 | Placebo | 225 mg BNC210 |
|---|---|---|---|---|
| Age, Continuous | 35.9 years STANDARD_DEVIATION 11.4 | 37.7 years STANDARD_DEVIATION 12.86 | 34.5 years STANDARD_DEVIATION 9.49 | 35.5 years STANDARD_DEVIATION 11.55 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 43 Participants | 16 Participants | 12 Participants | 15 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 108 Participants | 35 Participants | 38 Participants | 35 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Liebowitz Social Anxiety Scale (LSAS) | 97.4 units on a scale STANDARD_DEVIATION 16.33 | 98.3 units on a scale STANDARD_DEVIATION 16.98 | 95.3 units on a scale STANDARD_DEVIATION 16.34 | 98.7 units on a scale STANDARD_DEVIATION 15.75 |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 5 Participants | 2 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 23 Participants | 7 Participants | 9 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 5 Participants | 1 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 115 Participants | 40 Participants | 36 Participants | 39 Participants |
| Sex: Female, Male Female | 95 Participants | 35 Participants | 27 Participants | 33 Participants |
| Sex: Female, Male Male | 56 Participants | 16 Participants | 23 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 50 | 0 / 51 | 0 / 50 |
| other Total, other adverse events | 6 / 50 | 10 / 51 | 3 / 50 |
| serious Total, serious adverse events | 0 / 50 | 0 / 51 | 0 / 50 |
Outcome results
Primary
Change From Baseline to the Average Subjective Units of Distress Scale (SUDS) Score of the 5-minute Performance Phase of a 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.
Time frame: Assessed over a single visit: Baseline; and the Performance Phase (0,1,2,3,4,5 minutes) of the Public Speaking Challenge, conducted 1 hour post-dose.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| 225 mg BNC210 | Change From Baseline to the Average Subjective Units of Distress Scale (SUDS) Score of the 5-minute Performance Phase of a Public Speaking Challenge | 22.42 score on a scale |
| 675 mg BNC210 | Change From Baseline to the Average Subjective Units of Distress Scale (SUDS) Score of the 5-minute Performance Phase of a Public Speaking Challenge | 24.26 score on a scale |
| Placebo | Change From Baseline to the Average Subjective Units of Distress Scale (SUDS) Score of the 5-minute Performance Phase of a Public Speaking Challenge | 29.03 score on a scale |
Secondary
Change From Baseline to the Average SUDS Score of the 2-minute Anticipation Phase of a 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.
Time frame: Assessed over a single visit: Baseline; and the Anticipation Phase (0,1,2 minutes) of the Public Speaking Challenge, conducted 1 hour post-dose.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| 225 mg BNC210 | Change From Baseline to the Average SUDS Score of the 2-minute Anticipation Phase of a Public Speaking Challenge | 15.18 score on a scale |
| 675 mg BNC210 | Change From Baseline to the Average SUDS Score of the 2-minute Anticipation Phase of a Public Speaking Challenge | 12.86 score on a scale |
| Placebo | Change From Baseline to the Average SUDS Score of the 2-minute Anticipation Phase of a Public Speaking Challenge | 18.95 score on a scale |
Secondary
Change From Baseline to the End of the 2-minute Anticipation Phase of Public Speaking Challenge in the SSPS-N Score
The SSPS-N is a self reported measure that assesses cognitions related to public speaking.The range is 0-25 with a higher total score indicating a higher level of negative cognitions.
Time frame: Assessed over a single visit: Baseline; and the Anticipation Phase (2 minutes) of the Public Speaking Challenge, conducted 1 hour post-dose.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| 225 mg BNC210 | Change From Baseline to the End of the 2-minute Anticipation Phase of Public Speaking Challenge in the SSPS-N Score | -0.38 score on a scale |
| 675 mg BNC210 | Change From Baseline to the End of the 2-minute Anticipation Phase of Public Speaking Challenge in the SSPS-N Score | -2.69 score on a scale |
| Placebo | Change From Baseline to the End of the 2-minute Anticipation Phase of Public Speaking Challenge in the SSPS-N Score | -1.25 score on a scale |
Secondary
Change From Baseline to the End of the 2-minute Anticipation Phase of Public Speaking Challenge in the STAI-State Score
The 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.
Time frame: Assessed over a single visit: Baseline; and the Anticipation Phase (2 minutes) of the Public Speaking Challenge, conducted 1 hour post-dose.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| 225 mg BNC210 | Change From Baseline to the End of the 2-minute Anticipation Phase of Public Speaking Challenge in the STAI-State Score | 5.77 score on a scale |
| 675 mg BNC210 | Change From Baseline to the End of the 2-minute Anticipation Phase of Public Speaking Challenge in the STAI-State Score | 5.45 score on a scale |
| Placebo | Change From Baseline to the End of the 2-minute Anticipation Phase of Public Speaking Challenge in the STAI-State Score | 9.04 score on a scale |
Secondary
Change From Baseline to the End of the 5-minute Performance Phase of Public Speaking Challenge in the Self Statements During Public Speaking - Negative Self Statements (SSPS-N) Score
The SSPS-N is a self reported measure that assesses cognitions related to public speaking.The range is 0-25 with a higher total score indicating a higher level of negative cognitions.
Time frame: Assessed over a single visit: Baseline; and the Performance Phase (5 minutes) of the Public Speaking Challenge, conducted 1 hour post-dose.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| 225 mg BNC210 | Change From Baseline to the End of the 5-minute Performance Phase of Public Speaking Challenge in the Self Statements During Public Speaking - Negative Self Statements (SSPS-N) Score | -1.54 score on a scale |
| 675 mg BNC210 | Change From Baseline to the End of the 5-minute Performance Phase of Public Speaking Challenge in the Self Statements During Public Speaking - Negative Self Statements (SSPS-N) Score | -1.79 score on a scale |
| Placebo | Change From Baseline to the End of the 5-minute Performance Phase of Public Speaking Challenge in the Self Statements During Public Speaking - Negative Self Statements (SSPS-N) Score | -0.77 score on a scale |
Secondary
Change From Baseline to the End of the 5-minute Performance Phase of Public Speaking Challenge in the State-Trait Anxiety Inventory (State Component; STAI-State) Score
The 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.
Time frame: Assessed over a single visit: Baseline; and the Performance Phase (5 minutes) of the Public Speaking Challenge, conducted 1 hour post-dose.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| 225 mg BNC210 | Change From Baseline to the End of the 5-minute Performance Phase of Public Speaking Challenge in the State-Trait Anxiety Inventory (State Component; STAI-State) Score | 3.83 score on a scale |
| 675 mg BNC210 | Change From Baseline to the End of the 5-minute Performance Phase of Public Speaking Challenge in the State-Trait Anxiety Inventory (State Component; STAI-State) Score | 3.04 score on a scale |
| Placebo | Change From Baseline to the End of the 5-minute Performance Phase of Public Speaking Challenge in the State-Trait Anxiety Inventory (State Component; STAI-State) Score | 4.71 score on a scale |
Post Hoc
Change From Baseline in the Area Under the Curve (AUC) of the Combined SUDS Scores of the Anticipation and Performance Phases of a 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.
Time frame: Assessed over a single visit: Baseline; and the Performance Phase (0,1,2,3,4,5 minutes) of the Public Speaking Challenge, conducted 1 hour post-dose.
Population: To increase the sample size for the post-hoc analysis, data were combined for the two active BNC210 treatment groups versus placebo. Only participants who completed the public speaking challenge were included.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| 225 mg BNC210 | Change From Baseline in the Area Under the Curve (AUC) of the Combined SUDS Scores of the Anticipation and Performance Phases of a Public Speaking Challenge. | 229.1 score on a scale * minutes |
| 675 mg BNC210 | Change From Baseline in the Area Under the Curve (AUC) of the Combined SUDS Scores of the Anticipation and Performance Phases of a Public Speaking Challenge. | 325.9 score on a scale * minutes |