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NCT00120250 · ClinicalTrials.gov registry record · Phase 4
Eszopiclone for Sleep Disturbance and Nightmares in Post-Traumatic Stress Disorder
A Phase 4 study, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- Phase 4
- Development phase
- 27
- Enrollment target
NCT00120250: Completed Phase 4 study, sponsored by Massachusetts General Hospital.
NCT00120250 is a Phase 4 study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 27 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00120250, a Phase 4 study, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 27 participants
- Enrollment target
Study Summary
The purpose of this study is to obtain data investigating the safety and efficacy of eszopiclone for the treatment of post-traumatic stress disorder (PTSD)-related sleep disturbance and the impact of improved sleep with eszopiclone treatment on neuroendocrine correlates of PTSD. The investigators hypothesize that eszopiclone will be significantly more effective than placebo and well tolerated for PTSD-related sleep disturbance, improvement in sleep will be associated with improvement in overall PTSD symptoms, and patients with PTSD-related sleep disturbances will have abnormal levels of stress hormones.
Primary Outcome
The SPRINT is a 8-item, clinician-administered scale assessing core and related symptoms of PTSD. Symptoms are rates on 5 point scales from 0 (not at all) to 4 (very much) where a higher value indicates a worse outcome.
Interventions
- DRUG Eszopiclone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2005-06 |
| Est. Completion | 2008-06 |
| Phase | Phase 4 |
What the finished NCT00120250 record still lists
NCT00120250 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 1 intervention - of which Eszopiclone is the first listed.
NCT00120250 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00120250 about?
NCT00120250 is a clinical study titled "Eszopiclone for Sleep Disturbance and Nightmares in Post-Traumatic Stress Disorder". The purpose of this study is to obtain data investigating the safety and efficacy of eszopiclone for the treatment of post-traumatic stress disorder (PTSD)-related sleep disturbance and the impact of improved sleep with eszopiclone treatment on neuroendocrine correlates of PTSD. The investigators hy...
What is the current status of trial NCT00120250?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 27 participants. The study started on 2005-06. Estimated completion is 2008-06.
What interventions are being tested in trial NCT00120250?
The interventions under investigation include: Eszopiclone (DRUG).
Who is sponsoring clinical trial NCT00120250?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00120250's enrollment target sits among peer trials
27 1651st of 2000 higher than 346 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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