NCT07489651招募中2 期
A Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of RE104 for Injection in the Treatment of Generalized Anxiety Disorder
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 64
- 试验地点
- 28
- 主要终点
- RE104 30 mg versus placebo change from Baseline at Week 4 in Hamilton Anxiety Rating Scale (HAM-A) total score
研究概览
简要总结
The purpose of this study is to determine if treatment with a single dose of RE104 for Injection reduces anxiety symptoms in participants with Generalized Anxiety Disorder (GAD) as compared to placebo.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has Generalized Anxiety Disorder as defined by DSM-5-TR
- •If female is not pregnant or planning to become pregnant. If male is not planning to make a partner pregnant.
- •Is willing and able to comply with the conditions and requirements of the study
排除标准
- •Has a significant risk of suicide
- •Has an active or medical history of bipolar disorder, schizophrenia, schizoaffective disorder, psychotic disorder and/or borderline personality disorder, or first-degree family history of psychosis or bipolar disorder
- •Has other concurrent psychiatric disorders that is the primary disorder.
- •Has other medically significant conditions rendering unsuitability for the study
- •Has used or will need to use prohibited medications or therapies
- •Has a known sensitivity or intolerance to study intervention or potential rescue medications
研究组 & 干预措施
Placebo
Placebo Comparator
A single subcutaneous injection of 0.9% sodium chloride for injection
干预措施: Placebo (Drug)
30 mg RE104
Experimental
A single subcutaneous injection of 30 mg RE104 for Injection
干预措施: RE104 for Injection (Drug)
结局指标
主要结局
RE104 30 mg versus placebo change from Baseline at Week 4 in Hamilton Anxiety Rating Scale (HAM-A) total score
时间窗: Week 4
The Hamilton Rating Scale for Anxiety (HAM-A) is a 14-item scale that is used to rate the severity of symptoms of anxiety. The total score ranges from 0-56 with higher scores representing greater severity of anxiety.
次要结局
- RE104 30 mg versus placebo changes in total score from baseline in Hamilton Anxiety Rating Scale (HAM-A)(Weeks 1, 2, 8 and 12)
- RE104 30 mg versus placebo percentage of participants with HAM-A response (≥50% reduction in score from Baseline)(Weeks 1, 2, 4, 8 and 12)
- RE104 30 mg versus placebo percentage of participants with HAM-A remission (total score ≤7)(Day 1 and Weeks 1, 2, 4, 8 and 12)
- RE104 30 mg versus placebo change from Baseline at Weeks 1, 2, 4, 8, and 12 in Hospital Anxiety and Depression Scale (HADS) depression subscore(Weeks 1, 2, 4, 8 and 12)
- RE104 30 mg versus placebo incidence of treatment-emergent adverse events (TEAEs) by frequency, severity and seriousness.(From dosing through study completion (post-dose follow-up is for 12 weeks))
研究者
研究点 (28)
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