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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: Completed Phase 4 study, sponsored by National Institute of Mental Health (NIMH).
NCT00050804 is a Phase 4 study that has completed, run by National Institute of Mental Health (NIMH). The registered enrollment target is 80 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT00050804 record still lists
NCT00050804 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 1 intervention - of which sertraline is the first listed.
NCT00050804 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00050804's enrollment target sits among peer trials
80 946th of 2000 higher than 1,021 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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