Evaluation of Stress Disorders
Completed · Phase 4
Conditions studied: Acute Traumatic Stress Disorders, Post-Traumatic Stress Disorders
In brief
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.
Key facts
- Study ID
- NCT00050804
- Run by
- National Institute of Mental Health (NIMH)
- People needed
- 80
- Starts
- 2002-12-01
- Expected to finish
- 2004-02-01
- Last updated by the study team
- 2008-03-04
Who can join
Age: any. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Subjects will be above seventh grade education level aged 18-65 years old and free of current or past psychopathology and organic central nervous system disorders that may interfere with the tests.
You may not qualify if…
- Ongoing medical illness that may interfere with the tests; psychiatric or neurological disorder (including seizure); Past or current substance abuse; Current psychotropic medication; current medication that may interfere with the tests; Impaired hearing; major uncorrected visual impairment, or migraine headache.
Where it is running
- National Institute of Mental Health (NIMH) — Bethesda, Maryland, United States
Full record on ClinicalTrials.gov
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