MedTrace Logo

Evaluation of Stress Disorders

NCT00050804 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2008-03-04

No results posted yet for this study

Summary

The purpose of this study is to examine the short-term consequences of trauma and to determine the effectiveness of the drug sertraline in preventing and treating post-traumatic stress disorder (PTSD) and acute stress disorder (ASD) symptoms.

ASD and PTSD are common consequences of exposure to traumatic events. Despite growing evidence of neurobiological dysfunction in ASD and PTSD, the origin of these disorders is still unknown. This study will attempt to identify psychophysiological markers of ASD and find an effective treatment for its symptoms.

Victims of serious motor vehicle collisions will be evaluated with clinical assessments and standardized questionnaires within 2 weeks after the accident. Symptoms of exaggerated startle, emotional reactivity to trauma-related and trauma-unrelated cues, and cerebellum functioning will be evaluated. Participants will be randomized to receive either sertraline or placebo (an inactive sugar pill) for 8 weeks. Psychometric testing and psychological evaluations will be conducted 4, 10, and 14 weeks after the accident and after a 2-week taper of the study medication.

Conditions

  • Acute Traumatic Stress Disorders
  • Post-Traumatic Stress Disorders

Interventions

DRUG

sertraline

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    lead NIH

Study Design

Purpose
TREATMENT

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2002-12-31
Completion
2004-02-29

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00050804 on ClinicalTrials.gov