NCT07786454尚未招募3 期
A Phase 3, Multicenter, Open-Label Extension Trial to Evaluate the Safety and Tolerability of SEP-363856 in the Treatment of Adults With Generalized Anxiety Disorder
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 1,120
- 主要终点
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and TEAEs Leading to Discontinuation
研究概览
简要总结
This is a global, Phase 3, multicenter, open-label extension trial designed to evaluate the long-term safety, tolerability and efficacy of SEP-363856 administered at doses of 50 milligrams (mg) or 75 mg per day in adult participants with generalized anxiety disorder (GAD) over a treatment period of 26 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female participants at least 18 years of age at the time of informed consent
- •Completed one of the prior GAD Phase 3 studies involving SEP-363856 through Week 8 without discontinuation of trial intervention
- •Able to continue treatment without interruption, and is considered by investigator to potentially benefit from SEP-363856
- •Participant is willing and able to comply with study procedures and visit schedule
- •i) Females of childbearing potential: negative pregnancy test and agreement to use acceptable contraception ii) Males: agreement to follow protocol-defined contraception and reproductive restrictions
排除标准
- •Diagnosis other than GAD that is the primary focus of treatment
- •Clinically significant psychiatric or medical condition that may interfere with study participation
- •Lifetime history of meeting Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for, or was diagnosed during the prior study with, a psychiatric disorder that would compromise accurate assessment of safety and efficacy outcomes
- •Clinically significant abnormal laboratory values or ECG findings
- •Significant suicide risk
- •Substance use/positive drug screen
- •Use of prohibited medications/therapies
- •Known sensitivity to SEP-363856
结局指标
主要结局
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and TEAEs Leading to Discontinuation
时间窗: Throughout the trial (up to Week 27)
次要结局
- Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score(Baseline, Weeks 8, 14, and 26)
- Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score(Baseline, Weeks 8, 14, and 26)
研究者
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