AzTrials
AzTrials

Acute Traumatic Stress DisordersPhase 4NCT00050804

Evaluation of Stress Disorders

A Phase 4 study testing sertraline in people with Acute Traumatic Stress Disorders and Post-Traumatic Stress Disorders, run by National Institute of Mental Health (NIMH) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
What is being tested?
sertraline
How many people
80 participants
Where
1 siteUnited States
Study dates
Dec 2002to Feb 2004
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • National Institute of Mental Health (NIMH)

    Bethesda, Maryland, 20892

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
sertraline
Keywords
Acute Stress Disorder, PTSD, Treatment, SSRI, Startle, Psychophysiology, Trauma, Anxiety, Emotion
Medical subject headings
Stress Disorders, Traumatic, Acute, Stress Disorders, Post-Traumatic, Wounds and Injuries, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • sertralineDrug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Dec 2002 (estimated)
  2. Study startDec 2002
  3. Study completionFeb 2004

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Enrolment
80 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00050804
Sponsor's protocol ID
030036
Other IDs
03-M-0036
Status last verified
Feb 2004
First submitted
19 Dec 2002
Last updated
4 Mar 2008
Results posted
No

Publications

  • Harvey AG, Bryant RA. The relationship between acute stress disorder and posttraumatic stress disorder: a prospective evaluation of motor vehicle accident survivors. J Consult Clin Psychol. 1998 Jun;66(3):507-12. doi: 10.1037//0022-006x.66.3.507.

    PubMed 9642889
  • Harvey AG, Bryant RA. The relationship between acute stress disorder and posttraumatic stress disorder: a 2-year prospective evaluation. J Consult Clin Psychol. 1999 Dec;67(6):985-8. doi: 10.1037//0022-006x.67.6.985.

    PubMed 10596520
  • Blanchard EB, Hickling EJ, Taylor AE, Loos W. Psychiatric morbidity associated with motor vehicle accidents. J Nerv Ment Dis. 1995 Aug;183(8):495-504. doi: 10.1097/00005053-199508000-00001.

    PubMed 7643060

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing sertraline in people with Acute Traumatic Stress Disorders and Post-Traumatic Stress Disorders, run by National Institute of Mental Health (NIMH) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00050804, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2008.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in