topiramate and Combat-Disorders

To evaluate the use of topiramate for the treatment of posttraumatic stress disorder (PTSD).. Ovid MEDLINE (1950 to June week 4, 2010), International Pharmaceutical Abstracts (1970 to May 2010), ISI Web of Science (1945 to July 3, 2010), and Iowa Drug Information Service (searched July 6, 2010) were searched using the terms posttraumatic stress disorder and topiramate. Guidelines and other sources were identified from bibliography searches.. All English-language human studies and case reports that evaluated the use of topiramate for treatment of PTSD were evaluated.. One case report, 1 case series, 2 open-label trials, and 1 placebo-controlled trial that used topiramate (monotherapy or adjunct) to treat civilian PTSD were identified and evaluated. The case report and case series reported subjective reduction of symptoms, and the open-label trials reported a significant reduction in PTSD Checklist-Civilian score. The placebo-controlled trial found no significant difference in Clinician-Administered PTSD Scale (CAPS) score. One open-label trial and 2 placebo-controlled trials that used topiramate in combat-related PTSD were identified and evaluated. The open-label trial reported a significant reduction in CAPS score, and 1 placebo-controlled trial reported a statistically significant difference in CAPS score. However, the other placebo-controlled trial found no significant differences. In some of the trials evaluated, the clinical significance of outcomes reported is difficult to determine. Adverse effects were reported throughout the trials but generally were not considered serious.. Based on the limited evidence available, topiramate is a possible alternative or adjunct option for patients with PTSD that is refractory to standard treatments.

Topics: Anticonvulsants; Combat Disorders; Female; Fructose; Humans; Male; Stress Disorders, Post-Traumatic; Topiramate; Treatment Outcome; United States; Veterans

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.. 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.. 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.. NCT 00725920.

Topics: Adolescent; Adult; Anticonvulsants; Combat Disorders; Double-Blind Method; Female; Fructose; Humans; Male; Middle Aged; Personality Inventory; Placebos; Psychiatric Status Rating Scales; Stress Disorders, Post-Traumatic; Topiramate; Treatment Outcome; Warfare

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.. 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.. 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.. 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.

Topics: Age Factors; Anticonvulsants; Chronic Disease; Combat Disorders; Double-Blind Method; Drug Administration Schedule; Exanthema; Fructose; Humans; Male; Middle Aged; Patient Dropouts; Psychiatric Status Rating Scales; Severity of Illness Index; Stress Disorders, Post-Traumatic; Time Factors; Topiramate; Treatment Outcome; Urinary Tract Infections; Veterans

Posttraumatic stress disorder (PTSD) is a disabling psychiatric disorder that is common among combat veterans and may lead to very poor sleep and disturbing nightmares.. To examine the safety and effectiveness of topiramate as add-on therapy for the management of combat-related PTSD and to examine the effects of topiramate on sleep and alcohol consumption.. We conducted an 8-week open-label pilot study of topiramate for male combat veterans (N = 43) with PTSD, with analysis of veterans who completed the protocol. Psychometric, sleep, and alcohol consumption assessments were conducted at baseline and at week 8.. Twenty-nine subjects completed the 8-week study. Significant reductions in Clinician Administered PTSD Scale scores were observed at the 8-week endpoint (from 86.3 +/- 21.1 to 67.1 +/- 25.1; p < 0.01). Decreases were seen in both Stanford Sleepiness Scale scores (from 10.5 +/- 0.72 to 9.0 +/- 0.58; p = 0.08) and Mississippi PTSD scores (from 120.4 +/- 6.5 to 111.5 +/- 20.9; p = 0.08), but the extent of the changes did not attain statistical significance for either scale. There was a significant reduction in the proportion of patients with nightmares (from 100% to 62%; p < 0.001) and patients who experienced anxiety that interfered with falling asleep (from 90% to 62%; p < 0.05). The proportion of patients with high-risk drinking patterns also decreased (from 31% to 14%). Two serious adverse events were reported during the study: an increase in low back pain and an episode of acute confusion.. When used in addition to other empiric therapy, topiramate may be effective at reducing general symptoms of combat-related PTSD and reducing high-risk alcohol intake and nightmares. Further randomized controlled trials of topiramate for the treatment of combat-related PTSD are warranted.

Topics: Adult; Aged; Aged, 80 and over; Alcoholism; Combat Disorders; Fructose; Humans; Male; Middle Aged; Pilot Projects; Stress Disorders, Post-Traumatic; Surveys and Questionnaires; Topiramate; Veterans