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NCT00560612 · ClinicalTrials.gov registry record · Phase 4
Secondary Prevention With Paroxetine vs. Placebo in Subthreshold Posttraumatic Stress Disorder (PTSD)
A Phase 4 study, sponsored by Durham VA Medical Center.
- Completed
- Registry status
- Phase 4
- Development phase
- 12
- Enrollment target
NCT00560612: Completed Phase 4 study, sponsored by Durham VA Medical Center.
NCT00560612 is a Phase 4 study that has completed, run by Durham VA Medical Center. The registered enrollment target is 12 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00560612, a Phase 4 study, has completed, sponsored by Durham VA Medical Center.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 12 participants
- Enrollment target
Study Summary
The purpose of this study is: 1) To document the effectiveness and tolerability of paroxetine for the treatment of subthreshold posttraumatic stress disorder (PTSD) in veterans in the early post-deployment period; and 2) To determine the potential efficacy of paroxetine in preventing the progression of anxiety symptoms to PTSD and other anxiety disorders, and improving overall veteran function.
Primary Outcome
Mean change scores in posttraumatic stress disorder symptoms. Raw scores may range from 0 (no symptoms) to 136 (severe symptoms; score of 136 is based on the first 17 CAPS items administered). A reduced CAPS score indicates a reduction in (improvement) PTSD symptoms, while an increase in CAPS score indicates an increase (worsening) in PTSD symptoms. The outcome measure is the change in scores before and after treatment. That is, the baseline and at 12 weeks difference scores.
Interventions
- DRUG Placebo
- DRUG Paroxetine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2006-01 |
| Est. Completion | 2008-07 |
| Phase | Phase 4 |
What the finished NCT00560612 record still lists
NCT00560612 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00560612 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00560612 about?
NCT00560612 is a clinical study titled "Secondary Prevention With Paroxetine vs. Placebo in Subthreshold Posttraumatic Stress Disorder (PTSD)". The purpose of this study is: 1) To document the effectiveness and tolerability of paroxetine for the treatment of subthreshold posttraumatic stress disorder (PTSD) in veterans in the early post-deployment period; and 2) To determine the potential efficacy of paroxetine in preventing the progression...
What is the current status of trial NCT00560612?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 12 participants. The study started on 2006-01. Estimated completion is 2008-07.
What interventions are being tested in trial NCT00560612?
The interventions under investigation include: Placebo (DRUG), Paroxetine (DRUG).
Who is sponsoring clinical trial NCT00560612?
This trial is sponsored by Durham VA Medical Center, which has 17 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00560612's enrollment target sits among peer trials
12 1913th of 2000 higher than 70 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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