title: Efficacy and safety of topiramate monotherapy in civilian posttraumatic stress disorder: a randomized, double-blind, placebo-controlled study.
abstract: OBJECTIVE
  This double-blind, placebo-controlled trial assessed efficacy and safety of topiramate monotherapy in civilian posttraumatic stress disorder (PTSD).
  
  
  METHODS
  Outpatients (18-64 years) with DSM-IV non-combat-related PTSD and Clinician-Administered PTSD Scale (CAPS) scores >or= 50 were eligible. Topiramate was started at 25 mg/day and titrated by 25-50 mg/week to 400 mg/day or maximum tolerated dose. Data were collected between April 26, 2002, and February 4, 2004. Primary efficacy, change in total CAPS score, and secondary efficacy measures were assessed by analysis of covariance in the intent-to-treat (ITT) population with last observation carried forward.
  
  
  RESULTS
  The ITT population comprised 38 patients with mean +/- SD baseline total CAPS scores of 88.3 +/- 13.8 (topiramate, N = 19) and 91.1 +/- 13.7 (placebo, N = 19). Although a decrease in total CAPS score was noted (topiramate, -52.7; placebo, -42.0), this difference was not statistically significant (p = .232). Topiramate-treated patients exhibited significant reductions in reexperiencing symptoms (CAPS cluster B: topiramate, 74.9%; placebo, 50.2%; p = .038) and Treatment Outcome PTSD scale (topiramate, 68.0%; placebo, 41.6%; p = .025). Reductions approaching statistical significance, based on a nominal p value, were noted in mean total Clinical Global Impressions-Improvement Scale scores (topiramate, 1.9 +/- 1.2; placebo, 2.6 +/- 1.1; p = .055).
  
  
  CONCLUSIONS
  These preliminary results suggest that further, adequately powered studies of topiramate for the treatment of civilian PTSD are warranted.
authors.affiliation: Department of Psychiatry and Behavioral Sciences, Oklahoma Health Sciences Center, University of Oklahoma, Oklahoma City 73104, USA. phebe-tucker@ouhsc.edu
authors.forename: Phebe
authors.initials: P
authors.lastname: Tucker
authors.forename: Richard P
authors.initials: RP
authors.lastname: Trautman
authors.forename: Dorothy B
authors.initials: DB
authors.lastname: Wyatt
authors.forename: Jamie
authors.initials: J
authors.lastname: Thompson
authors.forename: Shu-Chen
authors.initials: SC
authors.lastname: Wu
authors.forename: Julie A
authors.initials: JA
authors.lastname: Capece
authors.forename: Norman R
authors.initials: NR
authors.lastname: Rosenthal
mesh_terms: D000293:Adolescent; D000328:Adult; D000927:Anticonvulsants / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D005632:Fructose / Q000031:analogs & derivatives; D006801:Humans; D008297:Male; D008875:Middle Aged; D012720:Severity of Illness Index; D013313:Stress Disorders, Post-Traumatic / Q000188:drug therapy*; D000077236:Topiramate; D016896:Treatment Outcome
chemical_list: D000927:Anticonvulsants; D000077236:Topiramate; D005632:Fructose