Ramaswamy Sriram, Driscoll David, Reist Christopher, Smith Lynette M, Albers Lawrence J, Rose Jodette, Nguyen Linda, Monga Varun, Doria Ryan, Hollifield Michael
Department of Veterans Affairs, VA Nebraska-Western Iowa Health Care System, 4101 Woolworth Ave, Omaha, NE 68105.
Department of Psychiatry, Creighton University, Omaha, Nebraska, USA.
Prim Care Companion CNS Disord. 2017 Aug 24;19(4):17m02138. doi: 10.4088/PCC.17m02138.
To determine the efficacy, safety, and tolerability of vilazodone in the treatment of posttraumatic stress disorder (PTSD) with comorbid mild-to-moderate depression.
A 12-week randomized, double-blind, placebo-controlled trial was conducted in adult outpatients who met DSM-IV criteria for PTSD with comorbid depression between February 2013 and September 2015. Participants were randomly assigned to receive vilazodone 40 mg/d or placebo, and outcome measures were obtained at scheduled visits. Primary outcome measures included change in PTSD symptoms from baseline to end of study as indexed by the Clinician-Administered PTSD Scale (CAPS) and PTSD Symptom Scale-Self-Report (PSS-SR). Secondary outcome measures of anxiety, depression, and impairment were obtained, as well as biomarker assessment at baseline and end of study.
A total of 59 patients were randomly assigned to receive vilazodone (n = 29) or placebo (n = 30). Of those who were randomized, there were 25 completers in the vilazodone group and 22 completers in the placebo group. No significant differences were observed between the groups on any of the primary or secondary outcome measures. Vilazodone was generally well tolerated with few differences in the rate of adverse events between groups.
Treatment with vilazodone 40 mg/d did not improve symptoms of PTSD and comorbid depression. Further investigation of the biological mechanisms underlying PTSD may lead to identification of improved therapeutic targets.
ClinicalTrials.gov identifier: NCT01715519.
确定维拉唑酮治疗合并轻至中度抑郁症的创伤后应激障碍（PTSD）的疗效、安全性和耐受性。
2013年2月至2015年9月，对符合DSM-IV标准的合并抑郁症的PTSD成年门诊患者进行了一项为期12周的随机、双盲、安慰剂对照试验。参与者被随机分配接受40mg/d的维拉唑酮或安慰剂，并在预定访视时获取结局指标。主要结局指标包括通过临床医生管理的PTSD量表（CAPS）和PTSD症状量表-自我报告（PSS-SR）所索引的从基线到研究结束时PTSD症状的变化。还获取了焦虑、抑郁和功能损害的次要结局指标，以及基线和研究结束时的生物标志物评估。
共有59名患者被随机分配接受维拉唑酮（n = 29）或安慰剂（n = 30）。在随机分组的患者中，维拉唑酮组有25名完成者，安慰剂组有22名完成者。在任何主要或次要结局指标上，两组之间均未观察到显著差异。维拉唑酮总体耐受性良好，两组不良事件发生率差异不大。
每天40mg维拉唑酮治疗未能改善PTSD和合并抑郁症的症状。对PTSD潜在生物学机制的进一步研究可能会导致确定更好的治疗靶点。
ClinicalTrials.gov标识符：NCT01715519。
