A Proof-of-Concept, Double-blind, Randomized, Placebo-controlled Study of Ganaxolone in Posttraumatic Stress Disorder
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 112
- 试验地点
- 8
- 主要终点
- Change From Baseline in Clinician-Administered Posttrautamtic Stress Disorder (PTSD) Scale (CAPS) to Week 6
研究概览
简要总结
This Phase 2 proof-of-concept study is a double-blind, randomized, placebo-controlled, 15-week investigation of ganaxolone versus placebo for the treatment of Posttraumatic Stress Disorder (PTSD). Up to 120 participants will be enrolled and randomized to receive either ganaxolone or placebo for 6 weeks. After 6 weeks of randomized treatment all participants will continue for 6 weeks on ganaxolone. The aim of the study is to assess the efficacy of ganaxolone compared to placebo for the treatment of PTSD symptoms after 6 weeks of treatment using the Clinician-Administered PTSD Rating Scale (CAPS). The second aim of the study is to evaluate the safety and tolerability of ganaxolone in the PTSD population.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Veteran or civilian adult outpatients 18-55 years of age, with primary PTSD as defined by Diagnostic and Statistical manual of Mental Disorders-IV (DSM-IV) for at least 6 months
- •Must be in general good health-confirmed by medical history, physical examination, and screening laboratory results
- •Negative urine drug screen for drugs of abuse
- •Negative urine pregnancy test for females of childbearing potential
- •Sexually active participants are required to use a medically acceptable form of birth control
- •Key Exclusion Criteria
- •Clinically unstable medical disease; progressive CNS disorder/disease; history of seizures (except childhood febrile seizure); moderate or severe traumatic brain injury (TBI)
- •Females who are pregnant or currently breast feeding
- •Current or past psychotic disorder, bipolar Type I disorder, or dementia
- •Participants with recent drug abuse or dependency (excluding nicotine and caffeine)
- •Participants unwilling to comply with the required alcohol prohibition during the trial
- •Current suicidal or homicidal ideation necessitating intervention, and those with a history of suicide attempt in the past 10 years
- •Participants with pending litigation related to the traumatic event
- •Participants who are unwilling to withhold grapefruit or grapefruit juice for the duration of the study
- •Participants receiving psychotherapy without a stable paradigm for at least 3 months
- •Non-English speaking participants.
排除标准
- 未提供
研究组 & 干预措施
Ganaxolone
active
干预措施: Ganaxolone (Drug)
Placebo
non-active
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Clinician-Administered Posttrautamtic Stress Disorder (PTSD) Scale (CAPS) to Week 6
时间窗: Baseline (Week 0) and at Week 2, Week 4 and Week 6
The CAPS was a structured interview that queries participants about each of the 17 Diagnostic and Statistical manual of Mental Disorders IV (DSM-IV) criteria B, C, and D symptoms of PTSD. Each item has a frequency score (0-4) and intensity score (0-4). The CAPS total score is the sum of frequency and intensity ratings for each item and the score range was 0: no symptoms to 136: severe symptoms. Higher score indicates worse symptoms. Baseline was defined as the Day 0 assessment before study drug infusion. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
次要结局
- Change From Baseline in Patient Health Questionnaire (PHQ-9) Score(Baseline (Week 0) and Week 6)
- Change From Baseline in Connor-Davidson Resilience Scale (CD-RISC) Score(Baseline (Week 0) and Week 6)
- Change From Baseline in PTSD Re-Experience Score(Baseline (Week 0) and at Week 2, Week 4 and Week 6)
- Change From Baseline in PTSD Avoidance Score(Baseline (Week 0) and at Week 2, Week 4 and Week 6)
- Change From Baseline in PTSD Hyperarousal Score(Baseline (Week 0) and at Week 2, Week 4 and Week 6)
- Number of Participants With Response to Clinical Global Impression - Improvement (Investigator) (CGI-II) Scale(Week 2, Week 4 and Week 6)
- Number of Participants With Response to CGI-I Subject Scale Clinical Global Impression - Improvement (Subject) (CGI-IS) Scale(Week 2, Week 4 and Week 6)
- Change From Baseline in PTSD Checklist (PCL) Scores(Baseline (Week 0) and at Week 2, Week 4 and Week 6)
- Change From Baseline in Profile of Mood States (POMS) Total Score(Baseline (Week 0) and Week 6)
- Change From Baseline in Insomnia Severity Index (ISI) Score(Baseline (Week 0) and Week 6)