A Study to Evaluate the Safety and Efficacy of NYX-783 in Subjects With Post-Traumatic Stress Disorder
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Aptinyx
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- CAPS-5 [Clinician-Administered PTSD Scale for DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition)] Total Score and Subscores
研究概览
简要总结
To evaluate the safety, tolerability, and response profile of NYX-783 in a Post-Traumatic Stress Disorder population.
详细描述
The study will be a 10 to 12-week study, including a 1 to 3-week screening Period, followed by a double-blind, randomized, placebo-controlled, parallel-group Treatment Period, and a 1-week follow-up Period. Subjects eligible for the study will be randomized to receive either NYX-783 (4-weeks) or placebo (4 or 8-weeks).
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A primary diagnosis of PTSD [Post Traumatic Stress Disorder, according to DSM-5 (Diagnostic and Statistical Manual of Mental Disorders)] with the primary traumatic event occurring ≥12 months prior to screening.
- •PCL-5 (PTSD Checklist for DSM-5) ≥38 at screening.
- •CAPS-5 (Clinician-Administered PTSD Scale for DSM-5) total score ≥30 at screening.
排除标准
- •Complex PTSD.
- •Trauma focused psychotherapies.
- •Primary traumatic event occurred prior to
- •Primary traumatic event was followed by further major traumatic life episodes.
- •Other psychiatric disorders that is the primary focus of treatment or followed/worsened since exposure to the trauma (except for major depressive disorder or anxiety disorders that followed exposure to the trauma or an anxiety disorder that showed a worsening after trauma)
- •Current use of medications with primarily central nervous system activities
- •Other clinically significant medical histories that may interfere with completing the study.
研究组 & 干预措施
Placebo
干预措施: Placebo oral capsule (Drug)
NYX-783 Low Dose (10 mg QD)
干预措施: NYX-783 (Drug)
NYX-783 High Dose (50 mg QD)
干预措施: NYX-783 (Drug)
结局指标
主要结局
CAPS-5 [Clinician-Administered PTSD Scale for DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition)] Total Score and Subscores
时间窗: Change from baseline to week 4 (Stage 1)
CAPS-5 \[Clinician Administered PTSD Scale for DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition)\] is a structured interview for diagnosis and assessment of PTSD. The assessor combines information about frequency and intensity of an item into a severity rating (0-4). CAPS-5 total symptom severity score is calculated by summing severity scores for the 20 DSM-5 PTSD symptoms. CAPS-5 symptom cluster severity scores are calculated by summing the individual item severity scores for symptoms corresponding to a given DSM-5 cluster: intrusions (items 1-5, minimum score 0, maximum score 20), avoidance (items 6-7, minimum score 0, maximum score 8), negative alterations in cognitions and mood (items 8-14, minimum score 0, maximum score 28), and alterations in arousal and reactivity (items 15-20, minimum score 0, maximum score 24). CAPS-5 Total Scores range from 0 to 80. A higher score corresponds to more severe PTSD.
次要结局
- PCL-5 (PTSD-Checklist for DSM-5)(Change from baseline to week 4 (Stage 1))
- PSQI (Pittsburgh Sleep Quality Index) Global Score(Change from baseline to week 4 (Stage 1))
- PSQI-A (Pittsburgh Sleep Quality Index-Addendum) Global Score(Change from baseline to week 4 (Stage 1))
- BAC (Brief Assessment of Cognition) Symbol Coding(Change from baseline to week 4 (Stage 1))
- CGI-S (Clinical Global Impression - Severity)(Change from baseline to week 4 (Stage 1))
- HADS-A (Hospital Anxiety and Depression Scale)(From baseline to week 4 (Stage 1))