A Phase 4 interventional study of Eszopiclone and Placebo in Posttraumatic Stress Disorders, sponsored by Rush University Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-12-23.
Sponsored by Rush University Medical Center · Phase 4, Interventional, and Treatment
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.
1,147 studies on the registry are indexed under Stress Disorders, Traumatic; 108 are open to participants now.
This study's enrollment of 81 is above the median of 60 across 908 interventional studies indexed under Stress Disorders, Traumatic.
Browse Stress Disorders, Traumatic studies →Rush University Medical Center is the lead sponsor of 394 studies on the registry; 61 are open to participants now.
Of its 30 completed or terminated interventional studies of FDA-regulated products, 25 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Drug: Eszopiclone
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.
Drug: Placebo
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.
Also known as: Lunesta®
The placebo used in this study looks exactly like eszopiclone but contains no active ingredients.
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.
Time frame: Between Baseline and Week 12
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).
Time frame: Changes in total score between Baseline and Week 12 (range of 0 to 21 worse)
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.
Time frame: Baseline and week 12
Cytokine Inflammatory Markers
Differences between baseline and week 12 on Interferon-Gamma, Interleukin-βeta, Interleukin-6, Tumor Necrosis Factor-alpha levels between treatment arms (eszopiclone versus placebo).
Time frame: Week 12
Cytokine Inflammatory Marker on Interleukin-2
Differences between baseline and week 12 on Interleukin-2 levels between treatment arms (eszopiclone versus placebo).
Time frame: Week 12
| Milestone | Eszopiclone | Placebo |
|---|---|---|
| Started | 13 | 12 |
| Completed | 7 | 9 |
| Not completed | 6 | 3 |
| Withdrew: Physician decision | 3 | 2 |
| Withdrew: Lost to follow-up | 3 | 1 |
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.
| units on a scale | Eszopiclone | Placebo |
|---|---|---|
| Change in Symptoms of Post-Traumatic Stress Disorder (PTSD) Between Baseline and Week 12 | -23 ± 17.61 | -20 ± 15.22 |
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).
| units on a scale | Eszopiclone | Placebo |
|---|---|---|
| Total Score on the Pittsburgh Sleep Quality Index With Post-Traumatic Stress Disorder Addendum (PSQI) | -4.13 ± 2.93 | -3.33 ± 3.59 |
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.
| units on a scale | Eszopiclone | Placebo |
|---|---|---|
| Changes in Emotional Bias Memory Encoding Between Baseline and Week 12 | 93 ± 31 | 102 ± 32 |
Differences between baseline and week 12 on Interferon-Gamma, Interleukin-βeta, Interleukin-6, Tumor Necrosis Factor-alpha levels between treatment arms (eszopiclone versus placebo).
| pg/ml | Eszopiclone | Placebo |
|---|---|---|
| Interferon-GAMMA pg/mL | 3.62 ± 13.98 | -1.55 ± 6.35 |
| Interleukin-βeta pg/mL | -0.10 ± 4 | 0.30 ± 7 |
| Interleukin-6 pg/mL | 1.29 ± 8 | -0.08 ± 9 |
| Tumor Necrosis Factor-alpha pg/mL | 67.27 ± 11 | 64.80 ± 10 |
Differences between baseline and week 12 on Interleukin-2 levels between treatment arms (eszopiclone versus placebo).
| IU | Eszopiclone | Placebo |
|---|---|---|
| Cytokine Inflammatory Marker on Interleukin-2 | 1.67 ± 8 | -0.07 ± 9 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Eszopiclone | — | 0/13 (0%) | 9/13 (69.2%) |
| Placebo | — | 0/12 (0%) | 9/12 (75%) |
| Event | Eszopiclone | Placebo |
|---|---|---|
| DysgeusiaGeneral disorders | 4/13 | 3/12 |
| HeadacheGeneral disorders | 2/13 | 3/12 |
| SedationGeneral disorders | 3/13 | 0/12 |
| Dry mouthGeneral disorders | 1/13 | 2/12 |
| GI distressGastrointestinal disorders | 2/13 | 1/12 |
| ConstipationGastrointestinal disorders | 1/13 | 1/12 |
| DiarrheaGastrointestinal disorders | 0/13 | 1/12 |
| DizzinessGeneral disorders | 0/13 | 1/12 |
| JitterinessGeneral disorders | 0/13 | 1/12 |
| Muscle crampingMusculoskeletal and connective tissue disorders | 0/13 | 1/12 |
| Age, Categorical(Participants) | Eszopiclone | Placebo | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 13 | 12 | 25 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Eszopiclone | Placebo | Total |
|---|---|---|---|
| Female | 5 | 5 | 10 |
| Male | 8 | 7 | 15 |
| Region of Enrollment(Participants) | Eszopiclone | Placebo | Total |
|---|---|---|---|
| United States | 13 | 12 | 25 |
This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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Rush University Medical Center