A randomized, double-blind, placebo-controlled trial of augmentation topiramate for chronic combat-related posttraumatic stress disorder.
BACKGROUND
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.


METHODS
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.


RESULTS
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.


CONCLUSIONS
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.
Lindley
Steven E
SE
Department of Psychiatry, Stanford University School of Medicine, Stanford, CA, USA. lindleys@stanford.edu
Carlson
Eve B
EB
Hill
Kimberly
K
D000367:Age Factors; D000927:Anticonvulsants / Q000009:adverse effects / Q000627:therapeutic use; D002908:Chronic Disease; D003130:Combat Disorders / Q000150:complications* / Q000523:psychology; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005076:Exanthema / Q000139:chemically induced; D005632:Fructose / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D006801:Humans; D008297:Male; D008875:Middle Aged; D010352:Patient Dropouts / Q000706:statistics & numerical data; D011569:Psychiatric Status Rating Scales; D012720:Severity of Illness Index; D013313:Stress Disorders, Post-Traumatic / Q000188:drug therapy* / Q000209:etiology / Q000523:psychology; D013997:Time Factors; D000077236:Topiramate; D016896:Treatment Outcome; D014552:Urinary Tract Infections / Q000139:chemically induced; D014728:Veterans
D000927:Anticonvulsants; D000077236:Topiramate; D005632:Fructose