Eszopiclone for the Treatment of Posttraumatic Stress Disorder
NCT ID: NCT01605253
Last Updated: 2022-12-23
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE4
81 participants
INTERVENTIONAL
2012-03-31
2015-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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
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.
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.
Placebo
The placebo used in this study looks exactly like eszopiclone but contains no active ingredients.
Interventions
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Eszopiclone
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.
Placebo
The placebo used in this study looks exactly like eszopiclone but contains no active ingredients.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Good physical health
* Willingness and ability to comply with the requirements of the study protocol
Exclusion Criteria
* Concurrent use of other psychotropic medications at least two weeks prior to baseline
* Concurrent use of other anti-inflammatory medications or anti-cytokine medications. If used on an as-needed (PRN) basis, subjects may enter the study, but will be excluded from cytokine analyses
* Concurrent use of beta-blockers less than one month prior to baseline
* Serious medical illness or instability for which hospitalization may be likely within the next year
* Seizure disorders with the exception of a history of febrile seizures if they occurred during childhood
* Sleep apnea or restless leg syndrome
* Concurrent psychotherapy initiated within 3 months of randomization or ongoing psychotherapy of any duration directed specifically toward treatment of PTSD and/or sleep disturbance
* Patients with significant suicidal ideation
* Current legal actions related to trauma or an ongoing relationship with assailant
18 Years
65 Years
ALL
No
Sponsors
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National Institute of Mental Health (NIMH)
NIH
Rush University Medical Center
OTHER
Responsible Party
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Principal Investigators
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Mark Pollack, MD
Role: PRINCIPAL_INVESTIGATOR
Rush University Medical Center
Locations
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Center for Anxiety and Traumatic Stress Disorders at Rush
Chicago, Illinois, United States
Countries
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