PMID- 18004136 OWN - NLM STAT- MEDLINE DCOM- 20080226 LR - 20181201 IS - 0271-0749 (Print) IS - 0271-0749 (Linking) VI - 27 IP - 6 DP - 2007 Dec TI - A randomized, double-blind, placebo-controlled trial of augmentation topiramate for chronic combat-related posttraumatic stress disorder. PG - 677-81 AB - 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. FAU - Lindley, Steven E AU - Lindley SE AD - Department of Psychiatry, Stanford University School of Medicine, Stanford, CA, USA. lindleys@stanford.edu FAU - Carlson, Eve B AU - Carlson EB FAU - Hill, Kimberly AU - Hill K LA - eng PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't PL - United States TA - J Clin Psychopharmacol JT - Journal of clinical psychopharmacology JID - 8109496 RN - 0 (Anticonvulsants) RN - 0H73WJJ391 (Topiramate) RN - 30237-26-4 (Fructose) SB - IM MH - Age Factors MH - Anticonvulsants/adverse effects/therapeutic use MH - Chronic Disease MH - Combat Disorders/*complications/psychology MH - Double-Blind Method MH - Drug Administration Schedule MH - Exanthema/chemically induced MH - Fructose/adverse effects/*analogs & derivatives/therapeutic use MH - Humans MH - Male MH - Middle Aged MH - Patient Dropouts/statistics & numerical data MH - Psychiatric Status Rating Scales MH - Severity of Illness Index MH - Stress Disorders, Post-Traumatic/*drug therapy/etiology/psychology MH - Time Factors MH - Topiramate MH - Treatment Outcome MH - Urinary Tract Infections/chemically induced MH - *Veterans EDAT- 2007/11/16 09:00 MHDA- 2008/02/27 09:00 CRDT- 2007/11/16 09:00 PHST- 2007/11/16 09:00 [pubmed] PHST- 2008/02/27 09:00 [medline] PHST- 2007/11/16 09:00 [entrez] AID - 00004714-200712000-00017 [pii] AID - 10.1097/jcp.0b013e31815a43ee [doi] PST - ppublish SO - J Clin Psychopharmacol. 2007 Dec;27(6):677-81. doi: 10.1097/jcp.0b013e31815a43ee.