A Phase 2b, Randomized, Double Blind, Two Arm Study to Investigate the Effects of BNC210 Tablet Formulation Compared to Placebo in Adults With Post-Traumatic Stress Disorder (PTSD)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 212
- 试验地点
- 2
- 主要终点
- Change From Baseline on the Clinician Administered Post-Traumatic Stress Disorder (PTSD) Scale for the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) (CAPS-5) Total Symptom Severity Scores After 12 Weeks
研究概览
简要总结
The purpose of this study is to assess the effects of BNC210 compared to placebo on Post-Traumatic Stress Disorder (PTSD) symptom severity as measured by the Clinician Administered PTSD scale for The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) (CAPS-5) Total Symptom Severity Scores.
详细描述
This is a randomized, double-blind, placebo-controlled, parallel group, multi-center study with a 12 week, 2-arm treatment period. Participants will attend a Screening visit within 3 weeks before randomization to confirm eligibility. Approximately 200 participants will be randomized using a 1:1 ratio to receive either BNC210 900 mg twice daily (b.i.d.) or matched placebo. Participants will then complete 12 weeks of treatment with their allocated study intervention. Participants will return to their study site at 2-weekly intervals to complete study assessments. Participants are then requested to attend a Follow-up visit at Week 15 (i.e., 3 weeks after their last study intervention is administered).
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants with a current diagnosis of PTSD as defined by the CAPS-5 for DSM-5, with a CAPS-5 Total Symptom Severity Score of ≥30 at Screening and Baseline and no >25% decrease in Score from Screening to Baseline
- •The index trauma event must have occurred in adulthood, i.e., when the participant was ≥18 years of age
- •Suitable contraception use in line with protocol requirements
- •Ability to swallow tablets
排除标准
- •A period of less than 6 months since the index trauma event
- •Current and ongoing exposure to the trauma that caused the PTSD
- •Complex PTSD
- •Severe depression as measured by a score of ≥ 35 on the Montgomery Asberg Depression Rating Scale (MADRS)
- •Borderline personality disorder, bipolar disorder and other psychotic disorders
- •Use of antidepressant medications within 30 days (fluoxetine within 90 days) of Screening. The use of alprazolam, flunitrazepam and chronic daily use of other benzodiazepines within 90 day of Screening.
- •Failed more than three trials of antidepressant medication(s) prescribed for the treatment of PTSD.
- •Concurrent trauma-based psychotherapy such as Cognitive Behavior Therapy, Prolonged Exposure Therapy, Eye Movement Desensitization and Reprocessing Therapy. Participants may however continue to receive supportive counseling that has been in place for a minimum of three months prior to Screening.
- •Any moderate or severe substance use disorder in the past 12 months
- •Any clinically significant medical history or findings as determined by the Investigator that could interfere with the objectives of the study or put the participant at risk
研究组 & 干预措施
BNC210
干预措施: BNC210 (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline on the Clinician Administered Post-Traumatic Stress Disorder (PTSD) Scale for the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) (CAPS-5) Total Symptom Severity Scores After 12 Weeks
时间窗: Baseline, 4 weeks, 8 weeks,12 weeks
The CAPS-5 is a 30-item structured interview used to diagnose PTSD and assess PTSD symptoms over the past month. Information about the frequency and intensity of each item is combined into a severity rating, and the CAPS-5 total symptom severity score is calculated by adding the severity scores for the 20 PTSD symptoms in the DSM-5. Scores range from 0 to 80, with higher scores indicating greater severity of PTSD symptoms.
次要结局
- Change From Baseline on Clinician Administered PTSD Scale for DSM-5 (CAPS-5) Criterion B Symptom Cluster Scores After 12 Weeks(Baseline, 4 weeks, 8 weeks, 12 weeks)
- Change From Baseline on Clinician Administered PTSD Scale for DSM-5 (CAPS-5) Criterion C Symptom Cluster Scores After 12 Weeks(Baseline, 4 weeks, 8 weeks, 12 weeks)
- Change From Baseline on Clinician Administered PTSD Scale for DSM-5 (CAPS-5) Criterion D Symptom Cluster Scores After 12 Weeks(Baseline, 4 weeks, 8 weeks, 12 weeks)
- Change From Baseline on Clinician Administered PTSD Scale for DSM-5 (CAPS-5) Criterion E Symptom Cluster Scores After 12 Weeks(Baseline, 4 weeks, 8 weeks, 12 weeks)
- Change From Baseline on Montgomery Asberg Depression Rating Scale (MADRS) Scores After 12 Weeks(Baseline, 4 weeks, 8 weeks, 12 weeks)
- Change From Baseline on Hamilton Anxiety Rating Scale (HAM-A) Scores After 12 Weeks(Baseline, 4 weeks, 8 weeks, 12 weeks)
- Change From Baseline on Clinician Global Impression - Severity (CGI-S) Scale Scores After 12 Weeks(Baseline, 4 weeks, 8 weeks, 12 weeks)
- Change From Baseline on Patient Global Impression - Severity (PGI-S) Scale Scores After 12 Weeks(Baseline, 4 weeks, 8 weeks, 12 weeks)
- Change From Baseline on Insomnia Severity Index (ISI) Scores After 12 Weeks(Baseline, 4 weeks, 8 weeks, 12 weeks)
- Change From Baseline on Sheehan Disability Scale (SDS) Scores After 12 Weeks(Baseline, 4 weeks, 8 weeks,12 weeks)
- Change From Baseline on PTSD Checklist for DSM-5 (PCL-5) Scores After 12 Weeks(Baseline, 12 weeks)