Eszopiclone for the Treatment of Posttraumatic Stress Disorder

Phase 4

Completed

Conditions: Posttraumatic Stress Disorders

Interventions: Drug: Placebo
Drug: Eszopiclone

Registration Number: NCT01605253

Lead Sponsor: Rush University Medical Center

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 81

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

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	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.
Eszopiclone	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.

Primary Outcome Measures

Name	Time	Method
Change in Symptoms of Post-Traumatic Stress Disorder (PTSD) Between Baseline and Week 12	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

Name	Time	Method
Cytokine Inflammatory Markers	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).
Total Score on the Pittsburgh Sleep Quality Index With Post-Traumatic Stress Disorder Addendum (PSQI)	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).
Changes in Emotional Bias Memory Encoding Between Baseline and Week 12	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 Marker on Interleukin-2	Week 12	Differences between baseline and week 12 on Interleukin-2 levels between treatment arms (eszopiclone versus placebo).