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NCT00665678 · ClinicalTrials.gov registry record · Phase 4
Neural Correlates of Early Intervention for Posttraumatic Stress Disorder (PTSD)
A Phase 4 study, sponsored by Foundation for Atlanta Veterans Education and Research.
- Terminated
- Registry status
- Phase 4
- Development phase
- 160
- Enrollment target
NCT00665678: Clinical Trial Phase 4 study, sponsored by Foundation for Atlanta Veterans Education and Research.
NCT00665678 is a Phase 4 study that was terminated before completion, run by Foundation for Atlanta Veterans Education and Research. The registered enrollment target is 160 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (69% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00665678, a Phase 4 study, was terminated before completion, sponsored by Foundation for Atlanta Veterans Education and Research.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 160 participants
- Enrollment target
Study Summary
Background: Innovation: Over 150,000 soldiers are currently deployed in Iraq as part of Operation Iraqi Freedom (OIF), and 12% of returning OIF veterans have posttraumatic stress disorder (PTSD). Research from our group and others showed lasting neurobiological consequences of PTSD, including increased amygdala function and decreased medial prefrontal function, verbal declarative memory problems, and smaller hippocampal volume that reverses with treatment with the serotonin reuptake inhibitor (SSRI) paroxetine or the anticonvulsant phenytoin. Recently we found that three months of treatment with paroxetine in PTSD patients resulted in an increase in hippocampal N-acetyl-aspartate (NAA), a marker of neuronal integrity, as well as decreased brain metabolism in the amygdala and a reversal or stress induced decreases in medial prefrontal function. Subjects treated with placebo did not have an increase in NAA, however subsequent treatment for three months with open label paroxetine resulted in an increase in NAA to the level seen in the subjects treated with paroxetine in the double-blind phase. Paroxetine was associated with a decrease in amygdala metabolism measured with positron emission tomography (PET) and increased medial prefrontal function. Intervening soon after the trauma is critical for long-term outcomes, since with time traumatic memories become indelible and resistant to treatment. Diminished efficacy of treatment over time is shown by the fact that trials of Vietnam veterans have shown less efficacy over the years. Animal studies show that pretreatment before stress with antidepressants reduces chronic behavioral deficits related to stress; although for ethical and other reasons no studies have provided pretreatment before trauma exposure in humans. In our current VA Merit funded program we are looking at the effects of early interventions for Iraq soldiers with paroxetine, looking at chronicity of PTSD, cognition, cortisol response to stress, hippocampal
Interventions
- DRUG placebo
- DRUG paroxetine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 160 participants |
| Start Date | 2008-04 |
| Est. Completion | 2012-03 |
| Phase | Phase 4 |
Why NCT00665678 stopped before completion
NCT00665678 is an interventional study that assigns participants to a tested intervention. The registered 160 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (69% lower).
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT00665678 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00665678 about?
NCT00665678 is a clinical study titled "Neural Correlates of Early Intervention for Posttraumatic Stress Disorder (PTSD)". Background: Innovation: Over 150,000 soldiers are currently deployed in Iraq as part of Operation Iraqi Freedom (OIF), and 12% of returning OIF veterans have posttraumatic stress disorder (PTSD). Research from our group and others showed lasting neurobiological consequences of PTSD, including increa...
What is the current status of trial NCT00665678?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 160 participants. The study started on 2008-04. Estimated completion is 2012-03.
What interventions are being tested in trial NCT00665678?
The interventions under investigation include: placebo (DRUG), paroxetine (DRUG).
Who is sponsoring clinical trial NCT00665678?
This trial is sponsored by Foundation for Atlanta Veterans Education and Research, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00665678's enrollment target sits among peer trials
160 507th of 2000 higher than 1,485 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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