Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00203463
Status:
COMPLETED
Last Update Posted:
2009-07-29
First Post:
2005-09-12
Brief Title:
Topiramate in the Treatment of Post Traumatic Stress Disorder PTSD
Sponsor:
Tuscaloosa Research Education Advancement Corporation
Organization:
Tuscaloosa Research Education Advancement Corporation
Study Overview
Official Title:
Topiramate in the Treatment of Post Traumatic Stress Disorder PTSD
Status:
COMPLETED
Status Verified Date:
2009-07
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:
To study the potential therapeutic effects of topiramate Topamax in the treatment of PTSD
Detailed Description:
This is a twelve-week randomized double blind placebo controlled trial of topiramate for 40 patients with PTSD Diagnoses are made by Structured Clinical Interview for DSM-IV SCID Symptom severity is measured with the Clinician Administered PTSD Scale CAPS Davidson Trauma Scale DTS Treatment Outcome PTSD TOP-8 Clinical Global Impressions CGI and the Hamilton Rating Scales for Depression and Anxiety HAM-D and HAM-A The Clinician Administered PTSD Scale CAPS is the primary outcome measure Subjects will read and sign informed consent prior to beginning any study procedures Subjects who meet inclusionexclusion criteria will be randomized 11 Topiramate placebo to study medication Study medication is initiated at one tablet daily 25mg topiramate or placebo and medication will be increased by 25-100mg 1 tablet increments every 7 days as tolerated until a maximum benefit is achieved not to exceed 400mgday Patients will be seen every week up until Visit 4 and then will be seen every two weeks for the remainder of the study for assessment of efficacy and side effects
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 |
|---|---|---|---|
| TREAC Topiramate in PTSD | None | None | None |