Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00215241
Status:
COMPLETED
Last Update Posted:
2014-09-22
First Post:
2005-09-20
Brief Title:
Risperidone Augmentation for PTSD
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Placebo-Controlled Trial of Risperidone Augmentation for SSRI-Resistant Civilian PTSD
Status:
COMPLETED
Status Verified Date:
2006-06
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 is to 1 compare the response of civilians with Posttraumatic Stress DisorderPTSD currently receiving sertraline without an optimal response to risperidone augmentation vs placebo and 2 to evaluate the tolerability of risperidone augmentation and 3 to identifiy predictors of response to risperidone augmentation the hypothesis is that risperidone augmentation of sertraline treatment of PTSD is safe and effective
Detailed Description:
This is a multi-center two-phase study to evaluate the efficacy and safety of risperidone augmentation to sertraline treatment of Post-Traumatic Stress Disorder PTSD In the first phase all patients will be assigned to take open label sertraline for 8 weeks up to 200 mgd Those who have not achieved a significant decrease in their PTSD symptoms by week 8 will be entered into the second phase In the second phase patients will continue with the sertraline but will then be randomly given either risperidone up to 3 mgd or matching placebo in double-blind fashion
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 |
|---|---|---|---|
| 5816-05-4R1 | OTHER | Duke legacy protocol ID | None |