A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of VQW-765 for the On-Demand Treatment of Acute Anxiety in Patients With Social Anxiety Disorder
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 500
- 试验地点
- 30
- 主要终点
- Subjective Units of Distress Scale (SUDS)
研究概览
简要总结
This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of a single oral dose of VQW-765 compared to placebo in adults with social anxiety disorder.
详细描述
The study will enroll approximately 500 patients with current diagnosis of social anxiety disorder (SAD). Eligible participants will be randomly assigned to receive either a single oral dose of VQW-765 or placebo in a 1:1 ratio, followed by a psychosocial stress test. 1-2 weeks after the treatment visit, a safety follow-up assessment will be conducted remotely.
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
- •Ability and willingness to provide written informed consent.
- •Male and female subjects aged 18-65 years, inclusive.
- •Current diagnosis of social anxiety disorder.
- •Liebowitz Social Anxiety Scale total score ≥
- •Public Speaking Anxiety Scale total score ≥
- •Hamilton Depression Rating Scale score ≤18.
排除标准
- •Suicide attempts and/or suicidal ideation in the past 2 years or currently at risk of suicide in the opinion of the investigator.
- •History of bipolar disorder, schizophrenia, psychosis, seizures, delusional disorders, obsessive-compulsive disorder, or autism spectrum disorder.
- •Posttraumatic stress disorder or an eating disorder in the past 6 months.
- •Substance or alcohol use disorder in the past 6 months or positive in drug/alcohol screening.
- •Psychotherapy in the past 6 months.
- •Psychotropic medication in the past 2 months.
- •Current or planned pregnancy or nursing during the trial period.
- •Any other reason as determined by the Investigator which may lead to an unfavorable risk-benefit of study participation, or interference with study objectives.
研究组 & 干预措施
Placebo
干预措施: Placebo (Drug)
VQW-765
干预措施: VQW-765 (Drug)
结局指标
主要结局
Subjective Units of Distress Scale (SUDS)
时间窗: 1 day
Subjective Units of Distress Scale (SUDS) during performance phase, scored from 0-100 with a higher score indicating higher distress.
Subjective Units of Distress Scale (SUDS)
时间窗: 1 day
Subjective Units of Distress Scale (SUDS) during performance phase, scored from 0-100 with a higher score indicating higher distress.
次要结局
- Subjective Units of Distress Scale (SUDS)(1 day)
- State-Trait Anxiety Inventory - State Anxiety Scale (STAI-S)(1 day)
- Subjective Units of Distress Scale (SUDS)(1 day)
- State-Trait Anxiety Inventory - State Anxiety Scale (STAI-S)(1 day)
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability](2 weeks)