drugset / Trial / NCT00050804

Evaluation of Stress Disorders

NCT00050804

Phase 4 Completed 80 enrolled National Institute of Mental Health (NIMH)
Treatment

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.

Timeline

Start
2002-12
Primary completion
Completion
2004-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Sertraline Small molecule