NCT06653296已完成2 期
A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Tolerability of ENX-102 and Determine a Dose-response for ENX-102 in Patients With Generalized Anxiety Disorder (GAD)
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
- 38
- 试验地点
- 1
- 主要终点
- Safety and tolerability
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled study to evaluate the safety and tolerability of ENX-102 and determine a dose-response for the effects of ENX-102 in patients with GAD
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
- •Male or female, inclusive of any gender identity, aged 18 to 65 years, inclusive
- •Diagnosed with GAD according to the DSM-V, confirmed by MINI
- •Experiencing clinically significant generalized anxiety as measured by HAM-A score ≥18 and at least moderately severe core symptoms of anxious mood and tension as measured by HAM-A Items 1 and 2, respectively, with scores each ≥2
排除标准
- •Clinically predominant psychiatric diagnosis other than GAD per the MINI
- •Any past/lifetime or current diagnosis of a neurocognitive disorder or psychotic disorder, or current posttraumatic stress disorder, obsessive compulsive disorder, or bipolar disorder
- •Ingested prohibited medication within 5 half-lives prior to Day 1
- •Current or recent moderate or severe substance use disorder as assessed by the MINI
- •Unwilling or unable to abstain from alcohol or other recreational psychoactive substances such as marijuana during participation in the trial
- •Has significant progressive disorders or unstable medical conditions
- •Is unable to comply with the requirements of the study or, in the opinion of the Investigator, is unsuitable for the study
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
ENX-102 low-dose
Experimental
ENX-102
干预措施: ENX-102 (Drug)
ENX-102 mid-dose
Experimental
ENX-102
干预措施: ENX-102 (Drug)
ENX-102 high-dose
Experimental
ENX-102
干预措施: ENX-102 (Drug)
结局指标
主要结局
Safety and tolerability
时间窗: 4 weeks
• Incidence and severity of treatment-emergent AEs (TEAEs)
次要结局
未报告次要终点
研究者
研究点 (1)
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