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Eszopiclone for Sleep Disturbance and Nightmares in Post-Traumatic Stress Disorder

NCT00120250 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2016-04-26

Study results available
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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.

Conditions

  • Post-Traumatic Stress Disorders

Interventions

DRUG

Eszopiclone

The total study duration is 8 weeks, with subjects receiving 3mg eszopiclone or placebo nightly for 3 weeks, followed by a 1 week washout period, followed by 3 weeks of the alternate condition, followed by another 1 week washout.

Sponsors & Collaborators

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Mark Pollack, M.D. · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-06-30
Primary Completion
2008-06-30
Completion
2008-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00120250 on ClinicalTrials.gov