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NCT00050804 · ClinicalTrials.gov registry record · Phase 4
Evaluation of Stress Disorders
A Phase 4 study, sponsored by National Institute of Mental Health (NIMH).
- Completed
- Registry status
- Phase 4
- Development phase
- 80
- Enrollment target
NCT00050804 is a Phase 4 study that has completed, run by National Institute of Mental Health (NIMH). The registered enrollment target is 80 participants.
The verdict
NCT00050804, a Phase 4 study, has completed, sponsored by National Institute of Mental Health (NIMH).
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 80 participants
- Enrollment target
Study 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.
Interventions
- DRUG sertraline
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2002-12 |
| Est. Completion | 2004-02 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00050804
The ClinicalTrials.gov registry entry for NCT00050804 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Mental Health (NIMH), which has 343 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which sertraline is the first listed.
NCT00050804 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00050804 about?
NCT00050804 is a clinical study titled "Evaluation of Stress Disorders". 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 trau...
What is the current status of trial NCT00050804?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 80 participants. The study started on 2002-12. Estimated completion is 2004-02.
What interventions are being tested in trial NCT00050804?
The interventions under investigation include: sertraline (DRUG).
Who is sponsoring clinical trial NCT00050804?
This trial is sponsored by National Institute of Mental Health (NIMH), which has 343 total clinical trials registered on ClinicalTrials.gov.
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