Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00203385
Status:
TERMINATED
Last Update Posted:
2017-04-26
First Post:
2005-09-12
Brief Title:
Maintenance Phase Treatment With Divalproex for Post Traumatic Stress Disorder
Sponsor:
Tuscaloosa Research Education Advancement Corporation
Organization:
Tuscaloosa Research Education Advancement Corporation
Study Overview
Official Title:
Maintenance Phase Treatment With Divalproex for Post Traumatic Stress Disorder
Status:
TERMINATED
Status Verified Date:
2017-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Funding expired
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective is to evaluate the long-term efficacy of divalproex sodium Depakote in the continuation treatment of PTSD
Detailed Description:
Patients who have participated in the 8-week randomized double-blind placebo-controlled treatment trial of divalproex for PTSD and have signed informed consent will be enrolled in a 24-week open-label divalproex continuation phase trial Patients symptoms side effects and compliance will be assessed every two weeks for 4 weeks then every 4 weeks thereafter up to 24-weeks Based on symptomology and occurrence of side effects the investigator will titrate the medication in 500 mg one tablet increments every four days as tolerated until a maximum therapeutic benefit is achieved not to exceed 3000 mgday The dosing is twice daily with the higher dose at bedtime Compliance will be assessed by monthly pill count and valproic acid levels at the weeks 4 12 and 24 Patients are given supportive clinical management during the clinic visits An investigator is available by telephone 24 hrs a day in case of emergency Patients may be seen more often if needed Efficacy will be measured by the structured rating scales for depression global function and assessment and PTSD Results of this study will be used to evaluate the long-term efficacy of divalproex in the maintenance treatment of PTSD
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