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Eszopiclone for the Treatment of Posttraumatic Stress Disorder

Primary Purpose

Posttraumatic Stress Disorders

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Eszopiclone
Placebo
Sponsored by
Rush University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Posttraumatic Stress Disorders focused on measuring Post-traumatic stress disorder, sleep disturbance, insomnia, cytokines, anxiety, traumatic event, memory

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Center for Anxiety and Traumatic Stress Disorders at Rush

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Eszopiclone

Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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 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.
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).
Cytokine Inflammatory Marker on Interleukin-2
Differences between baseline and week 12 on Interleukin-2 levels between treatment arms (eszopiclone versus placebo).

Full Information

First Posted
May 10, 2012
Last Updated
November 30, 2022
Sponsor
Rush University Medical Center
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT01605253
Brief Title
Eszopiclone for the Treatment of Posttraumatic Stress Disorder
Official Title
Eszopiclone for the Treatment of PTSD
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rush University Medical Center
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorders
Keywords
Post-traumatic stress disorder, sleep disturbance, insomnia, cytokines, anxiety, traumatic event, memory

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
81 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Eszopiclone
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Eszopiclone
Other Intervention Name(s)
Lunesta®
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
The placebo used in this study looks exactly like eszopiclone but contains no active ingredients.
Primary Outcome Measure Information:
Title
Change in Symptoms of Post-Traumatic Stress Disorder (PTSD) Between Baseline and Week 12
Description
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
Secondary Outcome Measure Information:
Title
Total Score on the Pittsburgh Sleep Quality Index With Post-Traumatic Stress Disorder Addendum (PSQI)
Description
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)
Title
Changes in Emotional Bias Memory Encoding Between Baseline and Week 12
Description
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
Title
Cytokine Inflammatory Markers
Description
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
Title
Cytokine Inflammatory Marker on Interleukin-2
Description
Differences between baseline and week 12 on Interleukin-2 levels between treatment arms (eszopiclone versus placebo).
Time Frame
Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Pollack, MD
Organizational Affiliation
Rush University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Anxiety and Traumatic Stress Disorders at Rush
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Eszopiclone for the Treatment of Posttraumatic Stress Disorder

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