Eszopiclone for the Treatment of Posttraumatic Stress Disorder
The purpose of this study is to determine if eszopiclone relative to placebo (sugar pill) is effective and tolerable for people with posttraumatic stress disorder (PTSD)-related sleep disturbance. The investigators will also examine the impact of treatment on sleep patterns, memory recall bias, and level of inflammatory markers (cytokines). The investigators predict eszopiclone will lead to greater improvement than placebo in measures of PTSD symptoms, memory recall bias, and level of inflammatory markers.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Eszopiclone for the Treatment of PTSD|
- Symptoms of Posttraumatic Stress Disorder [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
- Sleep disturbance [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]Total sleep time, sleep latency, and number of awakenings.
- Memory recall bias [ Time Frame: Baseline and week 12 (pre and post treatment) ] [ Designated as safety issue: No ]
- Inflammatory markers (cytokines) [ Time Frame: Baseline and week 12 (pre and post treatment) ] [ Designated as safety issue: No ]
|Study Start Date:||March 2012|
|Estimated Study Completion Date:||June 2015|
|Estimated Primary Completion Date:||June 2015 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01605253
|Contact: Elizabeth Kaiser, M.A||312-563-6687 ext 36687||Elizabeth_Kaiser@rush.edu|
|Contact: Sheila M Dowd, PhD||312-942-7281 ext firstname.lastname@example.org|
|United States, Illinois|
|Center for Anxiety and Traumatic Stress Disorders at Rush||Recruiting|
|Chicago, Illinois, United States, 60612|
|Contact: Elizabeth C Kaiser, MA 312-563-6687 ext 36687 Elizabeth_Kaiser@rush.edu|
|Contact: Sheila M Dowd, PhD 312-942-7281 ext 27281 email@example.com|
|Principal Investigator:||Mark Pollack, MD||Rush University Medical Center|