Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00078767
Status:
COMPLETED
Last Update Posted:
2017-04-05
First Post:
2004-03-05
Brief Title:
Pharmacologic Treatment of PTSD in Sexually Abused Children
Sponsor:
Allegheny Singer Research Institute also known as Allegheny Health Network Research Institute
Organization:
Allegheny Singer Research Institute also known as Allegheny Health Network Research Institute
Study Overview
Official Title:
Pharmacologic Treatment of PTSD in Sexually Abused Children
Status:
COMPLETED
Status Verified Date:
2017-04
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:
This study will evaluate the benefit of adding sertraline Zoloft to Trauma-Focused Cognitive Behavioral Therapy TF-CBT for sexually abused children who have Posttraumatic Stress Disorder PTSD
Detailed Description:
Adult research has demonstrated the efficacy of selective serotonin reuptake inhibitors SSRIs in decreasing Posttraumatic Stress Disorder PTSD symptoms to date the SSRIs are the only medication class with demonstrated efficacy in treating all three PTSD symptom clusters reexperiencing avoidance and hyperarousal No studies have evaluated the impact of SSRIs on PTSD symptoms in children or adolescents Trauma-focused CBT has been shown in several studies to be efficacious in decreasing PTSD symptoms in sexually abused children and adolescents Many children and youth with PTSD are currently prescribed SSRIs and other medications This study will evaluate whether adding the SSRI sertraline provides additional benefits over TF-CBT treatment for sexually abused children and adolescents with PTSD If adequate numbers of children with comorbid PTSD and depressive andor anxiety disorders are included it may also be possible to evaluate whether any benefit of adding sertraline is restricted to those children with comorbid disorders
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 |
|---|---|---|---|
| K02MH001938 | NIH | None | httpsreporternihgovquickSearchK02MH001938 |