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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01605253
Other study ID # 1R34MH091338-01A1
Secondary ID 1R34MH091338-01A
Status Completed
Phase Phase 4
First received
Last updated
Start date March 2012
Est. completion date December 2015

Study information

Verified date November 2022
Source Rush University Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 81
Est. completion date December 2015
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Intervention

Drug:
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.

Locations

Country Name City State
United States Center for Anxiety and Traumatic Stress Disorders at Rush Chicago Illinois

Sponsors (2)

Lead Sponsor Collaborator
Rush University Medical Center National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Symptoms of Post-Traumatic Stress Disorder (PTSD) Between Baseline and Week 12 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. Between Baseline and Week 12
Secondary Total Score on the Pittsburgh Sleep Quality Index With Post-Traumatic Stress Disorder Addendum (PSQI) 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). Changes in total score between Baseline and Week 12 (range of 0 to 21 worse)
Secondary Changes in Emotional Bias Memory Encoding Between Baseline and Week 12 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. Baseline and week 12
Secondary Cytokine Inflammatory Markers Differences between baseline and week 12 on Interferon-Gamma, Interleukin-ßeta, Interleukin-6, Tumor Necrosis Factor-alpha levels between treatment arms (eszopiclone versus placebo). Week 12
Secondary Cytokine Inflammatory Marker on Interleukin-2 Differences between baseline and week 12 on Interleukin-2 levels between treatment arms (eszopiclone versus placebo). Week 12
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