- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01605253
Eszopiclone for the Treatment of Posttraumatic Stress Disorder
November 30, 2022 updated by: Rush University Medical Center
Eszopiclone for the Treatment of PTSD
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
81
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Illinois
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Chicago, Illinois, United States, 60612
- Center for Anxiety and Traumatic Stress Disorders at Rush
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 63 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male or female outpatients age 18-65 with a primary diagnosis of PTSD and associated sleep disturbance
- Good physical health
- Willingness and ability to comply with the requirements of the study protocol
Exclusion Criteria:
- Women pregnant, lactating, or of childbearing potential not using medically accepted contraception
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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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.
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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 Names:
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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.
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The placebo used in this study looks exactly like eszopiclone but contains no active ingredients.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Symptoms of Post-Traumatic Stress Disorder (PTSD) Between Baseline and Week 12
Time Frame: Between Baseline and Week 12
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The Clinician-Administered PTSD Scale (CAPS) is a highly detailed measure of the presence and severity of the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-IV) Post-Traumatic Stress Disorder (PTSD) criteria.
The severity score was calculated by adding up the frequency score (scale 0 = "none of the time" to 4 = "most or all of the time") and an intensity score (scale 0 = "none" to 4 = "extreme"), which can then be summed for all 17 symptom questions and/or for the three symptom clusters.
Scores range from 0 to 136, where greater than or equal to 80 represents extreme PTSD symptomatology.
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Between Baseline and Week 12
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total Score on the Pittsburgh Sleep Quality Index With Post-Traumatic Stress Disorder Addendum (PSQI)
Time Frame: Changes in total score between Baseline and Week 12 (range of 0 to 21 worse)
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This standard daily sleep diary addresses timing of sleep, ability to fall and stay asleep, dreams, nightmares, and factors which can affect sleep (e.g.
caffeine).
It requires a summary of the subscales: Duration of sleep + Sleep Disturbance + Sleep Latency + Days of dysfunction due to sleepiness + Sleep efficiency + Overall Sleep Quality + Needing medication to sleep.
All subscales are measured from 0 to 3 (Minimum Score = 0 better; Maximum Score = 3 worse).
The Minimum TOTAL Score is 0 (better) and Maximum TOTAL Score is 21 (worse).
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Changes in total score between Baseline and Week 12 (range of 0 to 21 worse)
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Changes in Emotional Bias Memory Encoding Between Baseline and Week 12
Time Frame: Baseline and week 12
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Changes in Emotional Bias Memory Encoding by measuring mean hits minus the false alarms at baseline and at week 12. Subjects perform an encoding session on the 1st day utilizing 147 picture slides, thirty six pictures with negative valence, 36 with neutral valence and additional 75 pictures randomly intermixed.
Higher false alarms are associated with lower emotional bias memory encoding.
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Baseline and week 12
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Cytokine Inflammatory Markers
Time Frame: Week 12
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Differences between baseline and week 12 on Interferon-Gamma, Interleukin-βeta, Interleukin-6, Tumor Necrosis Factor-alpha levels between treatment arms (eszopiclone versus placebo).
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Week 12
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Cytokine Inflammatory Marker on Interleukin-2
Time Frame: Week 12
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Differences between baseline and week 12 on Interleukin-2 levels between treatment arms (eszopiclone versus placebo).
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Week 12
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Mark Pollack, MD, Rush University Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2012
Primary Completion (Actual)
December 1, 2015
Study Completion (Actual)
December 1, 2015
Study Registration Dates
First Submitted
May 10, 2012
First Submitted That Met QC Criteria
May 22, 2012
First Posted (Estimate)
May 24, 2012
Study Record Updates
Last Update Posted (Estimate)
December 23, 2022
Last Update Submitted That Met QC Criteria
November 30, 2022
Last Verified
November 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1R34MH091338-01A1 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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