A Phase 3, Multicenter, Randomized, Double-blind Trial of Fixed-Dose 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
- 591
- 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 fixed-dose brexpiprazole + sertraline combination treatment in adult subjects 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 post-traumatic stress disorder (PTSD), diagnosed according to 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 development 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
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 (2 mg) + Sertraline
Randomized participants received brexpiprazole 2 milligrams (mg), orally, once daily (QD) in combination with sertraline, 150 mg, orally, QD from Week 1 to Week 12 of the double-blind treatment (DBT) period.
干预措施: Sertraline (Drug)
Brexpiprazole (2 mg) + Sertraline
Randomized participants received brexpiprazole 2 milligrams (mg), orally, once daily (QD) in combination with sertraline, 150 mg, orally, QD from Week 1 to Week 12 of the double-blind treatment (DBT) period.
干预措施: Brexpiprazole (Drug)
Brexpiprazole (3 mg) + Sertraline
Randomized participants received brexpiprazole 3 mg, orally, QD in combination with sertraline, 150 mg, orally, QD from Week 1 to Week 12 of the DBT period.
干预措施: Brexpiprazole (Drug)
Brexpiprazole (3 mg) + Sertraline
Randomized participants received brexpiprazole 3 mg, orally, QD in combination with sertraline, 150 mg, orally, QD from Week 1 to Week 12 of the DBT period.
干预措施: Sertraline (Drug)
Sertraline + Placebo
Randomized participants received sertraline 150 mg, orally, QD, in combination with sertraline matching placebo, orally, QD from Week 1 to Week 12 of the DBT period.
干预措施: Sertraline (Drug)
Sertraline + Placebo
Randomized participants received sertraline 150 mg, orally, QD, in combination with sertraline matching placebo, orally, QD from Week 1 to Week 12 of the DBT period.
干预措施: Placebo (Other)
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 was a structured interview designed to assess PTSD diagnostic status and 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 categories: Category B: Intrusion symptoms (5 items); Category C: Avoidance symptoms (2 items); Category D: Cognition and mood symptoms (7 items); Category E: Arousal and 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, to yield 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 effect of treatment, trial site, visit week, and an interaction term of treatment by visit week, and included the interaction term of baseline values by visit week 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 of Psychosocial Functions (B-IPF) Score(Baseline, Week 12)