Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00120250
Status:
COMPLETED
Last Update Posted:
2016-04-26
First Post:
2005-07-07
Brief Title:
Eszopiclone for Sleep Disturbance and Nightmares in Post-Traumatic Stress Disorder
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Eszopiclone for Sleep Disturbance and Nightmares in Post-Traumatic Stress Disorder
Status:
COMPLETED
Status Verified Date:
2016-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
Post-traumatic stress disorder PTSD is characterized by three symptom groupings re-experiencing symptoms including flashbacks nightmares and intrusive memories physiological hyperarousal and avoidance symptoms Of the three major categories of symptoms in PTSD listed by the Diagnostic and Statistical Manual of Mental Disorders sleep-related problems are listed in two of them difficulty falling asleep is considered an aspect of hyperarousal symptoms and nightmares are a type of re-experiencing symptom Both are found commonly in PTSD Little is known about the relationship of neuroendocrine dysregulation in PTSD and sleep disturbance It is possible that successful treatment of sleep disturbance in PTSD may alter an abnormal stress hormone pattern The novel cyclopyrrolone hypnotic eszopiclone thus presents an intriguing opportunity to examine the treatment of sleep disturbances and nightmares in PTSD This study will determine the safety efficacy and impact on neuroendocrine parameters of eszopiclone compared to placebo for sleep disturbance and overall PTSD symptoms in individuals with PTSD and reported sleep disturbance
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None