Skip to main content
OpenTrials
Completed

NCT Number: NCT01605253

Eszopiclone for the Treatment of Posttraumatic Stress Disorder

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Posttraumatic Stress Disorders Anxiety Disorders Dyssomnias Mental Disorders Nervous System Diseases Parasomnias Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Center for Anxiety and Traumatic Stress Disorders at Rush

Chicago, Illinois, 60612, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Lunesta®

Placebo

Drug

The placebo used in this study looks exactly like eszopiclone but contains no active ingredients.

Primary outcomes

  1. Change in Symptoms of Post-Traumatic Stress Disorder (PTSD) Between Baseline and Week 12

    Time frame: 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 outcomes

  1. 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)

    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).

  2. Changes in Emotional Bias Memory Encoding Between Baseline and Week 12

    Time frame: 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.

  3. Cytokine Inflammatory Markers

    Time frame: Week 12

    Differences between baseline and week 12 on Interferon-Gamma, Interleukin-βeta, Interleukin-6, Tumor Necrosis Factor-alpha levels between treatment arms (eszopiclone versus placebo).

  4. Cytokine Inflammatory Marker on Interleukin-2

    Time frame: Week 12

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

Sponsors and collaborators

Lead sponsor

Rush University Medical Center

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Eszopiclone for the Treatment of PTSD

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
May 24, 2012
Registry last updated
Dec 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.