NCT04800237已完成2 期
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of VQW-765 in Patients With Performance Anxiety
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 230
- 试验地点
- 1
- 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 male and female participants with performance anxiety.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ability and willingness to provide written informed consent.
- •Sufficiently fluent in English to participate in the trial.
- •Male and female patients aged 18-70 years (inclusive).
排除标准
- •Lifetime history of bipolar disorder, schizophrenia, psychosis, seizures, delusional disorders or obsessive-compulsive disorder.
- •Current or planned pregnancy or nursing during the trial period.
- •A positive test for substances of abuse.
研究组 & 干预措施
VQW-765
Experimental
干预措施: VQW-765 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Subjective Units of Distress Scale (SUDS)
时间窗: 1 Day
次要结局
- Clinician Global Impression of Change (CGI-C) scale at visit 2(1 Day)
- Patient Global Impression of Change (PGI-C) scale at visit 2(1 Day)
- Assessment of safety and tolerability of a single dose of VQW-765, as measured by spontaneous reporting of adverse events (AEs)(1 Day)
研究者
研究点 (1)
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