Eszopiclone for the Treatment of Posttraumatic Stress Disorder
|ClinicalTrials.gov Identifier: NCT01605253|
Recruitment Status : Completed
First Posted : May 24, 2012
Last Update Posted : April 15, 2016
|Condition or disease||Intervention/treatment||Phase|
|Posttraumatic Stress Disorders||Drug: Eszopiclone Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||81 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Eszopiclone for the Treatment of PTSD|
|Study Start Date :||March 2012|
|Primary Completion Date :||December 2015|
|Study Completion Date :||December 2015|
Active Comparator: Eszopiclone
The total study duration is 16 weeks, with subjects taking 3mg eszopiclone at bedtime for 12 weeks. There is one follow-up visit after the 12 week treatment phase.
Eszopiclone has been approved by the US Food and Drug Administration (FDA) for the treatment of insomnia (inability to sleep). Eszopiclone has not been specifically approved by the FDA for people who have PTSD-related sleep disturbance.
Other Name: Lunesta®
Placebo Comparator: Placebo
The total study duration is 16 weeks, with subjects taking placebo at bedtime for 12 weeks. There is one follow-up visit after the 12 week treatment phase.
The placebo used in this study looks exactly like eszopiclone but contains no active ingredients.
- Symptoms of Posttraumatic Stress Disorder [ Time Frame: 16 weeks ]
- Sleep disturbance [ Time Frame: 16 weeks ]Total sleep time, sleep latency, and number of awakenings.
- Memory recall bias [ Time Frame: Baseline and week 12 (pre and post treatment) ]
- Inflammatory markers (cytokines) [ Time Frame: Baseline and week 12 (pre and post treatment) ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01605253
|United States, Illinois|
|Center for Anxiety and Traumatic Stress Disorders at Rush|
|Chicago, Illinois, United States, 60612|
|Principal Investigator:||Mark Pollack, MD||Rush University Medical Center|