SSRI Administration to Reduce Acute Stress Disorder Symptoms and Prevent Depression and PTSD in Physical Trauma Victims

Anxiety Disorder Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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 medical/surgical 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 (i.e., 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 mg/d) versus placebo. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Anxiety Disorder
• Anxiety Disorders
• Disease
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic
• Stress Disorders, Traumatic, Acute

• NCT number: NCT00114374
• Study type: Interventional
• Source: Massachusetts General Hospital
• Status: Terminated
• Phase: Phase 3
• Start date: June 2005
• Completion date: June 2007