title: A randomized, double-blind, placebo-controlled trial to assess the efficacy of topiramate in the treatment of post-traumatic stress disorder.
abstract: BACKGROUND
  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.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  NCT 00725920.
authors.affiliation: Department of Psychiatry, Universidade Federal de São Paulo, São Paulo, Brazil. mf-mello@uol.com.br
authors.forename: Marcelo Feijó
authors.initials: MF
authors.lastname: Mello
authors.forename: Mary Sau Ling
authors.initials: MS
authors.lastname: Yeh
authors.forename: Jair
authors.initials: J
authors.lastname: Barbosa Neto
authors.forename: Luciana Lorens
authors.initials: LL
authors.lastname: Braga
authors.forename: Jose Paulo
authors.initials: JP
authors.lastname: Fiks
authors.forename: Daniela Deise
authors.initials: DD
authors.lastname: Mendes
authors.forename: Tais S
authors.initials: TS
authors.lastname: Moriyama
authors.forename: Nina Leão Marques
authors.initials: NL
authors.lastname: Valente
authors.forename: Mariana Caddrobi Pupo
authors.initials: MC
authors.lastname: Costa
authors.forename: Patricia
authors.initials: P
authors.lastname: Mattos
authors.forename: Rodrigo Affonseca
authors.initials: RA
authors.lastname: Bressan
authors.forename: Sergio Baxter
authors.initials: SB
authors.lastname: Andreoli
authors.forename: Jair Jesus
authors.initials: JJ
authors.lastname: Mari
mesh_terms: D000293:Adolescent; D000328:Adult; D000927:Anticonvulsants / Q000627:therapeutic use*; D003130:Combat Disorders / Q000175:diagnosis / Q000188:drug therapy* / Q000523:psychology; D004311:Double-Blind Method; D005260:Female; D005632:Fructose / Q000031:analogs & derivatives* / Q000627:therapeutic use; D006801:Humans; D008297:Male; D008875:Middle Aged; D010555:Personality Inventory; D010919:Placebos; D011569:Psychiatric Status Rating Scales / Q000706:statistics & numerical data; D013313:Stress Disorders, Post-Traumatic / Q000175:diagnosis / Q000188:drug therapy* / Q000523:psychology; D000077236:Topiramate; D016896:Treatment Outcome; D014857:Warfare
chemical_list: D000927:Anticonvulsants; D010919:Placebos; D000077236:Topiramate; D005632:Fructose