Evaluation of Stress Disorders

NCT00050804 | Completed Phase 4

• 2 other identifiers: 03003603-M-0036
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Traumatic Stress Disorders; Post-Traumatic Stress Disorders

Keywords

Acute Stress Disorder; PTSD; Treatment; SSRI; Startle; Psychophysiology; Trauma; Anxiety; Emotion

Interventions

sertraline DRUG

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• National Institute of Mental Health (NIMH): lead

Study Sites (1)

National Institute of Mental Health (NIMH)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• 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.

  PMID: 9642889 BACKGROUND

• 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.

  PMID: 10596520 BACKGROUND

• 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.

  PMID: 7643060 BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Traumatic, Acute; Stress Disorders, Post-Traumatic; Wounds and Injuries; Anxiety Disorders

Interventions

Sertraline

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

1-Naphthylamine; Amines; Organic Chemicals; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: December 19, 2002
• First Posted: December 20, 2002
• Study Start: December 1, 2002
• Study Completion: February 1, 2004
• Last Updated: March 4, 2008

Record last verified: 2004-02

Locations

US (1)