A randomized, double-blind, placebo-controlled trial to assess the efficacy of topiramate in the treatment of post-traumatic stress disorder.
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.
Mello
Marcelo Feijó
MF
Department of Psychiatry, Universidade Federal de São Paulo, São Paulo, Brazil. mf-mello@uol.com.br
Yeh
Mary Sau Ling
MS
Barbosa Neto
Jair
J
Braga
Luciana Lorens
LL
Fiks
Jose Paulo
JP
Mendes
Daniela Deise
DD
Moriyama
Tais S
TS
Valente
Nina Leão Marques
NL
Costa
Mariana Caddrobi Pupo
MC
Mattos
Patricia
P
Bressan
Rodrigo Affonseca
RA
Andreoli
Sergio Baxter
SB
Mari
Jair Jesus
JJ
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
D000927:Anticonvulsants; D010919:Placebos; D000077236:Topiramate; D005632:Fructose