Safety & Efficacy Study Using Topiramate in Posttraumatic Stress Disorder

Status Completed

Clinical Trial Summary

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

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00204386
Study type	Interventional
Source	University of Oklahoma
Contact
Status	Completed
Phase	Phase 2/Phase 3
Start date	September 2002
Completion date	May 2007

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.