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| ID | Type | Description | Link |
|---|---|---|---|
| 1R34MH091338-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eszopiclone | Active Comparator | 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. |
|
| Placebo | Placebo Comparator | 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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eszopiclone | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Pollack, MD | Rush University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Anxiety and Traumatic Stress Disorders at Rush | Chicago | Illinois | 60612 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Eszopiclone | Participants receives 3mg of eszopiclone nightly for 12 weeks, followed by a one month follow-up. |
| FG001 | Placebo | Participants receives 3mg of placebo nightly for 12 weeks, followed by a one month follow-up. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Of the 25 subjects that were randomized, 9 did not complete the study. | Posted | Mean | Standard Deviation | units on a scale | Between Baseline and Week 12 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Eszopiclone | Participants receives 3mg of eszopiclone nightly for 12 weeks, followed by a one month follow-up. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mark Pollack, MD | Rush University Medical Center | 3129425372 | mark_pollack@rush.edu |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| D020447 | Parasomnias |
| D007319 | Sleep Initiation and Maintenance Disorders |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
| D012893 | Sleep Wake Disorders |
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| ID | Term |
|---|---|
| D000069582 | Eszopiclone |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011719 | Pyrazines |
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|
| Placebo | Drug | The placebo used in this study looks exactly like eszopiclone but contains no active ingredients. |
|
| 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. | 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). | Week 12 |
| Cytokine Inflammatory Marker on Interleukin-2 | Differences between baseline and week 12 on Interleukin-2 levels between treatment arms (eszopiclone versus placebo). | Week 12 |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
Participants receives 3mg of eszopiclone nightly for 12 weeks, followed by a one month follow-up.
| OG001 | Placebo | Participants receives 3mg of placebo nightly for 12 weeks, followed by a one month follow-up. |
|
|
| 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). | Of the 25 subjects that were randomized, 9 did not complete the study. | Posted | Mean | Standard Deviation | units on a scale | 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. | Subjects with pre treatment and post treatment emotional bias encoding assessments | Posted | Mean | Standard Error | units on a scale | Baseline and week 12 |
|
|
|
| Secondary | 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). | Subjects with baseline and week 12 cytokine assessments | Posted | Mean | Standard Deviation | pg/ml | 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). | Subjects with baseline and week 12 cytokine assessment of Interleukin-2 IU | Posted | Mean | Standard Deviation | IU | Week 12 |
|
|
|
| 0 |
| 13 |
| 9 |
| 13 |
| EG001 | Placebo | Participants receives 3mg of placebo nightly for 12 weeks, followed by a one month follow-up. | 0 | 12 | 9 | 12 |
| Appetite Increase | Metabolism and nutrition disorders | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Dry mouth | General disorders | Systematic Assessment |
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| Dysgeusia | General disorders | Systematic Assessment |
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| GI distress | Gastrointestinal disorders | Systematic Assessment |
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| Dizziness | General disorders | Systematic Assessment |
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| Headache | General disorders | Systematic Assessment |
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| Jitteriness | General disorders | Systematic Assessment |
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| Muscle cramping | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Memory impairment | General disorders | Systematic Assessment |
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| Sexual dysfunction | Reproductive system and breast disorders | Systematic Assessment |
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| Urinary hesitation | Renal and urinary disorders | Systematic Assessment |
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| Fatigue | General disorders | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Sedation | General disorders | Systematic Assessment |
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| Sweating | General disorders | Systematic Assessment |
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| Disturbing dreams | General disorders | Systematic Assessment |
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| D009422 | Nervous System Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D011725 |
| Pyridines |
| Interleukin-6 pg/mL |
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| Tumor Necrosis Factor-alpha pg/mL |
|