Evaluation of Stress Disorders

March 3, 2008 updated by: National Institute of Mental Health (NIMH)

Efficacy of an SSRI in Acute Stress Disorder and PTSD

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Acute stress disorder (ASD) and posttraumatic stress disorder (PTSD) are common consequences of exposure to traumatic events. Despite growing evidence of neurobiological dysfunction in ASD and PTSD, the pathogenesis of these disorders is still unknown. Drs. Osuch and Ursano (Uniformed Services University of the Health Sciences) have received support to conduct a 14-week study that will investigate the efficacy of the serotonergic medication sertraline (Zoloft) in the treatment and prevention of posttraumatic psychiatric sequelae in ASD victims. The present project is an amendment to Drs. Osuch and Ursano's study. It will attempt to identify early psychological and neurobiological abnormalities in ASD. More specifically, the present project will examine to what extent sensitization and conditioning processes, as well as emotional dysregulation, contribute to ASD. We also propose to investigate the potential association between cerebellum dysfunction and peritraumatic dissociations. To accomplish this goal, a series of three experiments will be implemented to investigate: 1) the symptom of exaggerated startle; 2) emotional reactivity to trauma-related and trauma-unrelated cues; and 3) cerebellum functioning using eyeblink conditioning. This study will inform on the short-term consequences of trauma, will help identify potential psychophysiological markers of ASD that emerge following trauma, and will examine the effects of an SSRI on preventing trauma-related neurobiological deficits.

We specifically propose to:

  1. Characterize psychophysiological responses in ASD victims shortly after trauma;
  2. Assess the effect of sertraline treatment on these psychophysiological responses.

To accomplish aim 1, non-treated ASD victims will be compared to two control groups, a non-ASD trauma group and a non-trauma healthy group. The two control groups will be used to disentangle the effect of trauma from the effect of acute stress disorder. To accomplish aim 2, the ASD sertraline group will be compared to the ASD placebo group following treatment.

Forty victims of serious motor vehicle collision (MVC) with ASD will be recruited from a community hospital emergency room and evaluated with clinical assessments, and standardized questionnaires within 2 weeks after the MVC. The subjects will then be randomized to either sertraline or placebo for 8 weeks duration. Psychometric testing and psychological evaluations will be conducted at 4, 10 weeks post-MVC, and after a 2-week taper of the medication and 2 more weeks (14 weeks post-MVC).

We hypothesize that ASD patients will show:

An enhancement or sensitization of baseline startle;

An increase in autonomic arousal and in startle amplitude to trauma-related cues;

A delayed eyeblink conditioning;

Normalization of these deficits after sertraline treatment.

This preliminary study is expected to lay the groundwork for a larger study of the early impact of traumatic events on psychophysiological and psychological processes. In the long-term, we expect to 1) better characterize the onset of symptoms and their evolution over time following trauma, 2) identify psychophysiological markers for PTSD, 3) identify ASD victims at-risk for PTSD, and 4) improve our ability to prevent the development of chronic psychopathology following trauma.

Study Type

Interventional

Enrollment

80

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20892
        • National Institute of Mental Health (NIMH)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

INCLUSION CRITERIA:

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.

EXCLUSION CRITERIA:

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Mental Health (NIMH)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2002

Study Completion

February 1, 2004

Study Registration Dates

First Submitted

December 19, 2002

First Submitted That Met QC Criteria

December 19, 2002

First Posted (Estimate)

December 20, 2002

Study Record Updates

Last Update Posted (Estimate)

March 4, 2008

Last Update Submitted That Met QC Criteria

March 3, 2008

Last Verified

February 1, 2004

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 030036
  • 03-M-0036

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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