Mello Marcelo Feijó, Yeh Mary Sau Ling, Barbosa Neto Jair, Braga Luciana Lorens, Fiks Jose Paulo, Mendes Daniela Deise, Moriyama Tais S, Valente Nina Leão Marques, Costa Mariana Caddrobi Pupo, Mattos Patricia, Bressan Rodrigo Affonseca, Andreoli Sergio Baxter, Mari Jair Jesus
Department of Psychiatry, Universidade Federal de São Paulo, São Paulo, Brazil.
BMC Psychiatry. 2009 May 29;9:28. doi: 10.1186/1471-244X-9-28.
Topiramate might be effective in the treatment of posttraumatic stress disorder (PTSD) because of its antikindling effect and its action in both inhibitory and excitatory neurotransmitters. Open-label studies and few controlled trials have suggested that this anticonvulsant may have therapeutic potential in PTSD. This 12-week randomized, double-blind, placebo-controlled clinical trial will compare the efficacy of topiramate with placebo and study the tolerability of topiramate in the treatment of PTSD.
Seventy-two adult outpatients with DSM-IV-diagnosed PTSD will be recruited from the violence program of Federal University of São Paulo Hospital (UNIFESP). After informed consent, screening, and a one week period of wash out, subjects will be randomized to either placebo or topiramate for 12 weeks. The primary efficacy endpoint will be the change in the Clinician-administered PTSD scale (CAPS) total score from baseline to the final visit at 12 weeks.
The development of treatments for PTSD is challenging due to the complexity of the symptoms and psychiatric comorbidities. The selective serotonin reuptake inhibitors (SSRIs) are the mainstream treatment for PTSD, but many patients do not have a satisfactory response to antidepressants. Although there are limited clinical studies available to assess the efficacy of topiramate for PTSD, the findings of prior trials suggest this anticonvulsant may be promising in the management of these patients.
NCT 00725920.
托吡酯可能对创伤后应激障碍（PTSD）的治疗有效，因其具有抗点燃效应以及对抑制性和兴奋性神经递质均有作用。开放性研究和少数对照试验表明，这种抗惊厥药物可能对PTSD具有治疗潜力。这项为期12周的随机、双盲、安慰剂对照临床试验将比较托吡酯与安慰剂的疗效，并研究托吡酯治疗PTSD的耐受性。
将从圣保罗联邦大学医院（UNIFESP）的暴力项目中招募72名符合DSM-IV诊断标准的PTSD成年门诊患者。在获得知情同意、完成筛查以及为期一周的洗脱期后，受试者将被随机分为接受安慰剂或托吡酯治疗12周。主要疗效终点将是从基线到12周最终访视时临床医生评定的PTSD量表（CAPS）总分的变化。
由于PTSD症状和精神共病的复杂性，开发其治疗方法具有挑战性。选择性5-羟色胺再摄取抑制剂（SSRIs）是PTSD的主流治疗方法，但许多患者对抗抑郁药的反应并不令人满意。尽管评估托吡酯治疗PTSD疗效的临床研究有限，但先前试验的结果表明，这种抗惊厥药物在治疗这些患者方面可能很有前景。
NCT 00725920。
