Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00133822
Status:
COMPLETED
Last Update Posted:
2015-08-19
First Post:
2005-08-22
Brief Title:
Civilian Post-Traumatic Stress Disorder Risperidone Clinical Trial
Sponsor:
Emory University
Organization:
Emory University
Study Overview
Official Title:
Placebo-Controlled Trial of Risperidone Augmentation for SSRI-Resistant Civilian PTSD
Status:
COMPLETED
Status Verified Date:
2015-08
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 determine whether the administration of risperidone is effective in the treatment of selective serotonin reuptake inhibitor SSRI-resistant post-traumatic stress disorder PTSD in civilians
Detailed Description:
Individuals with PTSD often experience anxiety attacks nightmares or repeated unwanted memories after experiencing or witnessing life-threatening events such as serious accidents or natural disasters or traumatic events such as physical or sexual abuse
Risperidone has been approved by the Food and Drug Administration for the treatment of psychotic disorders and has been found helpful for PTSD and depression but is still considered investigational for the purposes of this study
All qualified participants will be started on sertraline Zoloft for eight weeks Patients who are still symptomatic at the end of this phase will be invited to join the second portion of the study where they will be randomly assigned to receive risperidone or placebo sugar pill in addition to the sertraline Participants will be monitored regularly for medication effects adverse events and PTSD symptoms
Risperidone has been approved by the Food and Drug Administration for the treatment of psychotic disorders and has been found helpful for PTSD and depression but is still considered investigational for the purposes of this study
All qualified participants will be started on sertraline Zoloft for eight weeks Patients who are still symptomatic at the end of this phase will be invited to join the second portion of the study where they will be randomly assigned to receive risperidone or placebo sugar pill in addition to the sertraline Participants will be monitored regularly for medication effects adverse events and PTSD symptoms
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 |
|---|---|---|---|
| RIS-EMR-4005 | OTHER | Other | None |