NCT00204386

Safety & Efficacy Study Using Topiramate in Posttraumatic Stress Disorder

A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Determine the Efficacy and Safety of Topiramate in the Treatment of Posttraumatic Stress Disorder

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: University of Oklahoma · Academic / Other
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study was to determine if Topiramate was safe and effective for use in civilian subjects with Posttraumatic Stress Disorder.

Detailed description

Civilian PTSD is a widespread psychiatric condition and is commonly underestimated in terms of prevalence and morbidity, at least in the United States and probably world-wide. The magnitude of the public health impact of PTSD is highlighted by recent epidemiologic findings. Kessler, et al, estimated a 7.8% lifetime prevalence for PTSD in a representative national sample of 5877 persons aged 15-54. In part, this high prevalence is due to the high occurrence of trauma exposure over a lifetime. Common types of Civilian PTSD include serious physical attack or assault, rape, sexual assault, transportation accidents, exposure to death/homicide or serious injury, life-threatening accidents, threats of injury with fire, floods, weapons, natural disasters and civilian exposure to military attacks. Persons with PTSD are usually unaware that they have this disorder and because treatment professionals have been inadequately sensitized to high prevalence of this condition, the condition is markedly undiagnosed and thereby undertreated. The risk of PTSD is not restricted to the psychiatric population. In general, persons with PTSD seek help in general medical and not mental health settings. Individuals with PTSD are at increased risk of co-morbid psychiatric disorders including depression, alcohol and drug abuse, panic disorder, agoraphobia and personality disorders. It is associated with a substantially higher suicide risk, hospitalization rates, and increased utilization rates of non-psychiatric medical services as well as mental health services.

Conditions

• Posttraumatic Stress Disorder

Interventions

Type	Name	Description
DRUG	Topiramate

Timeline

• Start date: 2002-09-01
• Completion: 2007-05-01
• First posted: 2005-09-20
• Last updated: 2007-05-30

Locations

1 site across 1 country: United States