Lindley Steven E, Carlson Eve B, Hill Kimberly
Department of Psychiatry, Stanford University School of Medicine, Stanford, CA, USA.
J Clin Psychopharmacol. 2007 Dec;27(6):677-81. doi: 10.1097/jcp.0b013e31815a43ee.
Topiramate, a novel anticonvulsant, has been reported to rapidly reduce symptoms of posttraumatic stress disorder (PTSD) in an open-label trial. The present study was designed as a test of topiramate's efficacy as adjunctive therapy in a 7-week, randomized, double-blind, placebo-controlled trial.
Forty male veterans with PTSD in a residential treatment program were randomized to flexible-dose topiramate or placebo augmentation. The primary outcome measures were PTSD symptom severity and global symptom improvement.
Baseline Clinician-Administered PTSD Scale scores were 62.1 +/- 13.9 for placebo and 61.0 +/- 22.2 for topiramate. There was a high dropout rate from the study (55% topiramate; 25% placebo), with 40% of topiramate and 10% of placebo dropping because of adverse events (AEs). No significant treatment effects of topiramate versus placebo were observed for the primary treatment outcomes. Subjects reporting central nervous system-related AEs and with higher baseline severity of depression were more likely to discontinue because of AEs.
Primary outcome measures failed to demonstrate a significant effect for topiramate over placebo; however, high dropout rate in the treatment group prohibits definitive conclusions about the efficacy of topiramate in this population.
托吡酯是一种新型抗惊厥药物，在一项开放标签试验中，据报道其可迅速减轻创伤后应激障碍（PTSD）的症状。本研究旨在通过一项为期7周的随机、双盲、安慰剂对照试验，检验托吡酯作为辅助治疗的疗效。
40名参加住院治疗项目的患有创伤后应激障碍的男性退伍军人被随机分配至灵活剂量托吡酯组或安慰剂增效组。主要结局指标为创伤后应激障碍症状严重程度和整体症状改善情况。
安慰剂组的基线临床医生管理的创伤后应激障碍量表评分为62.1±13.9，托吡酯组为61.0±22.2。该研究的脱落率很高（托吡酯组为55%；安慰剂组为25%），其中40%的托吡酯组患者和10%的安慰剂组患者因不良事件而退出。在主要治疗结局方面，未观察到托吡酯与安慰剂之间存在显著的治疗效果差异。报告有中枢神经系统相关不良事件且基线抑郁严重程度较高的受试者更有可能因不良事件而停药并退出。
主要结局指标未能证明托吡酯比安慰剂有显著效果；然而，治疗组的高脱落率妨碍了对托吡酯在该人群中疗效得出明确结论。
