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NCT01605253 · ClinicalTrials.gov registry record · Phase 4
Eszopiclone for the Treatment of Posttraumatic Stress Disorder
A Phase 4 study, sponsored by Rush University Medical Center.
- Completed
- Registry status
- Phase 4
- Development phase
- 81
- Enrollment target
NCT01605253: Completed Phase 4 study, sponsored by Rush University Medical Center.
NCT01605253 is a Phase 4 study that has completed, run by Rush University Medical Center. The registered enrollment target is 81 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01605253, a Phase 4 study, has completed, sponsored by Rush University Medical Center.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 81 participants
- Enrollment target
Study Summary
The purpose of this study is to determine if eszopiclone relative to placebo (sugar pill) is effective and tolerable for people with posttraumatic stress disorder (PTSD)-related sleep disturbance. The investigators will also examine the impact of treatment on sleep patterns, memory recall bias, and level of inflammatory markers (cytokines). The investigators predict eszopiclone will lead to greater improvement than placebo in measures of PTSD symptoms, memory recall bias, and level of inflammatory markers.
Primary Outcome
The Clinician-Administered PTSD Scale (CAPS) is a highly detailed measure of the presence and severity of the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-IV) Post-Traumatic Stress Disorder (PTSD) criteria. The severity score was calculated by adding up the frequency score (scale 0 = "none of the time" to 4 = "most or all of the time") and an intensity score (scale 0 = "none" to 4 = "extreme"), which can then be summed for all 17 symptom questions and/or for the three
Interventions
- DRUG Placebo
- DRUG Eszopiclone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 81 participants |
| Start Date | 2012-03 |
| Est. Completion | 2015-12 |
| Phase | Phase 4 |
What the finished NCT01605253 record still lists
NCT01605253 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 81 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (84% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01605253 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01605253 about?
NCT01605253 is a clinical study titled "Eszopiclone for the Treatment of Posttraumatic Stress Disorder". The purpose of this study is to determine if eszopiclone relative to placebo (sugar pill) is effective and tolerable for people with posttraumatic stress disorder (PTSD)-related sleep disturbance. The investigators will also examine the impact of treatment on sleep patterns, memory recall bias, and ...
What is the current status of trial NCT01605253?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 81 participants. The study started on 2012-03. Estimated completion is 2015-12.
What interventions are being tested in trial NCT01605253?
The interventions under investigation include: Placebo (DRUG), Eszopiclone (DRUG).
Who is sponsoring clinical trial NCT01605253?
This trial is sponsored by Rush University Medical Center, which has 320 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01605253's enrollment target sits among peer trials
81 940th of 2000 higher than 1,055 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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