Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00114374
Status:
TERMINATED
Last Update Posted:
2014-06-09
First Post:
2005-06-14
Brief Title:
SSRI Administration to Reduce Acute Stress Disorder Symptoms and Prevent Depression and PTSD in Physical Trauma Victims
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
SSRI Administration to Reduce Acute Stress Disorder Symptoms and Prevent Depression and Posttraumatic Stress Disorder in Physical Trauma Victims in the Medical Setting
Status:
TERMINATED
Status Verified Date:
2014-06
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 examine the efficacy of escitalopram compared to placebo in reducing Acute Stress Disorder ASD symptoms and in preventing the emergence of Post-Traumatic Stress Disorder PTSD in patients with medical trauma who are at risk for the development of PTSD based on the presence of ASD symptoms
Detailed Description:
Posttraumatic Stress Disorder PTSD is a relatively common distressing and disabling condition that may occur after trauma related events including injury The emergence of Acute Stress Disorder shortly after the trauma appears to be a strong predictor of who will later develop PTSD Brewin et al 1999 Although SSRIs are commonly administered in general medical practice and have been demonstrated effective for the treatment of PTSD there has not been systematic study of their use for the treatment of ASD ASD symptoms or the prevention of PTSD and this study represents one of the first attempts to systematically evaluate their use for this indication
Sixty study participants for 30 randomized will be drawn from patients admitted to the Massachusetts General Hospital medicalsurgical inpatient units for a traumatic injury that occurred in the prior 3 weeks Study participants must meet criteria for the A1 A2 and at least one additional category of Acute Stress Disorder symptoms ie B C and or D criteria as determined by the Acute Stress Disorder Interview upon initial evaluation to qualify for randomization in a 12 week double-blind flexible-dose treatment trial of escitalopram 10-40 mgd versus placebo
Sixty study participants for 30 randomized will be drawn from patients admitted to the Massachusetts General Hospital medicalsurgical inpatient units for a traumatic injury that occurred in the prior 3 weeks Study participants must meet criteria for the A1 A2 and at least one additional category of Acute Stress Disorder symptoms ie B C and or D criteria as determined by the Acute Stress Disorder Interview upon initial evaluation to qualify for randomization in a 12 week double-blind flexible-dose treatment trial of escitalopram 10-40 mgd versus placebo
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