At a glance
ClinicalIndex Comparison Record- ✓Primary diagnosis of PTSD per DSM-IV criteria with associated sleep disturbance
- ✓Age 18–64 years
- ✓Outpatient status
- ✕Schizophrenia, bipolar disorder, OCD, or organic medical disorders
- ✕Eating disorders in the past 6 months
- ✕Alcohol or substance abuse in the past 3 months, or dependence within the past 6 months
- ✕Significant suicidal ideation or suicidal behavior in the past 6 months
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Eszopiclone for Sleep Disturbance and Nightmares in Post-Traumatic Stress Disorder
In Brief
A Phase 4 clinical trial evaluating Eszopiclone for Post-Traumatic Stress Disorders. Completed, enrolled 27 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
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.