CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed
Drug / intervention
sertralinedrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00050804
NCT00050804Phase 4Completed

Efficacy of an SSRI in Acute Stress Disorder and PTSD

National Institute of Mental Health (NIMH)·interventional·Posted Dec 20, 2002·Updated Mar 4, 2008

In Brief

A Phase 4 clinical trial evaluating sertraline for Acute Traumatic Stress Disorders and Post-Traumatic Stress Disorders. Completed, across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 20, 2002
Enrollment StartDec 1, 2002
Study CompletionFeb 1, 2004
TodayJul 2, 2026
Posted 23.5 years ago

Interventions

sertralinedrug