Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00204386
Status:
COMPLETED
Last Update Posted:
2007-05-30
First Post:
2005-09-12
Brief Title:
Safety Efficacy Study Using Topiramate in Posttraumatic Stress Disorder
Sponsor:
University of Oklahoma
Organization:
University of Oklahoma
Study Overview
Official Title:
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
Status Verified Date:
2007-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 78 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 deathhomicide 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| IRB10198 | None | None | None |