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
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 370
- 试验地点
- 22
- 主要终点
- Subjective Units of Distress Scale (SUDS)
研究概览
简要总结
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.
详细描述
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.
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
- •A current diagnosis of social anxiety disorder as defined in the DSM-
- •A Liebowitz Social Anxiety Scale total score of ≥
- •Suitable contraception use in line with protocol requirements.
- •Ability to swallow tablets.
排除标准
- •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 ≥
- •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.
研究组 & 干预措施
Placebo
干预措施: Placebo (Drug)
225 mg BNC210
干预措施: 225 mg BNC210 (Drug)
结局指标
主要结局
Subjective Units of Distress Scale (SUDS)
时间窗: 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.
次要结局
- Clinical Global Impressions-Severity (CGI-S)(1 day)
- Patient Global Impressions-Improvement (PGI-I)(1 day)
- State-Trait Anxiety Inventory (State Component; STAI-State)(1 day)