A Phase 2, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of BNC210 Compared to Placebo for the Acute Treatment of Social Anxiety Disorder
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 151
- 试验地点
- 1
- 主要终点
- Change From Baseline to the Average Subjective Units of Distress Scale (SUDS) Score of the 5-minute Performance Phase of a Public Speaking Challenge
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
675 mg BNC210
干预措施: 675 mg BNC210 (Drug)
225 mg BNC210
干预措施: 225 mg BNC210 (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline to the Average Subjective Units of Distress Scale (SUDS) Score of the 5-minute Performance Phase of a Public Speaking Challenge
时间窗: 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.
次要结局
- 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.)
- 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.)
- 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.)
- 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.)
- 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.)