A Phase 3, Multicenter, Randomized, Double-blind Trial of Brexpiprazole as Combination Therapy With Sertraline in the Treatment of Adults With Post-traumatic Stress Disorder
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 450
- 试验地点
- 1
- 主要终点
- Change From Baseline in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Total Score
研究概览
简要总结
This will be a 12-week, multicenter, randomized, double-blind trial evaluating the efficacy, safety, and tolerability of brexpiprazole + sertraline combination treatment in adult participants with Post-Traumatic Stress Disorder.
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
- Double (Participant, Investigator)
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
- •Male and female outpatients 18 to 65 years of age, inclusive, at the time of informed consent.
- •Participants who have PTSD, diagnosed according to the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5), and confirmed by the Mini International Neuropsychiatric Interview (MINI).
- •Onset of symptoms meeting the DSM-5 criteria for PTSD symptoms for a minimum of 6 months prior to screening.
排除标准
- •The index traumatic event that led to the develop of PTSD took place > 9 years before screening.
- •The index traumatic event occurred before age
- •Participants who have experienced a traumatic event within 3 months of screening.
- •Participants who are receiving disability payments because of PTSD or any other psychiatric disorder; unless the disability payments will not be impacted by potential improvements demonstrated in the trial.
研究组 & 干预措施
Sertraline + Placebo
Randomized participants received sertraline, 150 mg, orally, QD along with sertraline matching placebo, orally, QD from Week 1 to Week 12 of the DBT period.
干预措施: Placebo (Other)
Brexpiprazole + Sertraline
Randomized participants received brexpiprazole as a flexible dose 2 milligrams (mg) to 3 mg, orally, once daily (QD) along with sertraline, at a fixed dose of 150 mg, orally, QD from Week 1 to Week 12 of the double-blind treatment (DBT) period.
干预措施: Sertraline (Drug)
Placebo
All enrolled participants received brexpiprazole-matched placebo tablets and sertraline-matched placebo tablets during the 1-week placebo run-in period.
干预措施: Placebo (Other)
Brexpiprazole + Sertraline
Randomized participants received brexpiprazole as a flexible dose 2 milligrams (mg) to 3 mg, orally, once daily (QD) along with sertraline, at a fixed dose of 150 mg, orally, QD from Week 1 to Week 12 of the double-blind treatment (DBT) period.
干预措施: Brexpiprazole (Drug)
Sertraline + Placebo
Randomized participants received sertraline, 150 mg, orally, QD along with sertraline matching placebo, orally, QD from Week 1 to Week 12 of the DBT period.
干预措施: Sertraline (Drug)
结局指标
主要结局
Change From Baseline in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Total Score
时间窗: Baseline (Week 1), Week 10
CAPS-5 is a structured interview designed to assess PTSD diagnostic status \& symptoms severity as defined by DSM-5. CAPS-5 total score was calculated by summing severity scores for 20 DSM-5 PTSD symptoms (items 1-20) from following categories: Category B: Intrusion symptoms (5 items); Category C: Avoidance symptoms (2 items); Category D: Cognition \& mood symptoms (7 items); Category E: Arousal \& reactivity symptoms (6 items). CAPS-5 total score was imputed by adding all subscores from categories B, C, D, E. Each symptom was scored 0= Absent to 4= Extreme/incapacitating, yielding a score range of 0-80. Higher scores indicate worse outcome. Least squares (LS) mean was determined by Mixed-effect model repeated measures (MMRM) method with fixed class effect terms for treatment, trial site, visit, previous treatment intervention for PTSD (Yes/No), \& an interaction term of treatment by visit, \& include the interaction term of baseline values of CAPS-5 total score by visit as a covariate.
次要结局
- Change in Clinical Global Impression - Severity (CGI-S) Score(Baseline (Week 1), Week 10)
- Change in Brief Inventory or Psychosocial Functions (B-IPF) Score(Baseline (Day 1), Week 12)