Clinical trial NCT01605253: Eszopiclone for the Treatment of Posttraumatic Stress Disorder
Official title: Eszopiclone for the Treatment of PTSD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Posttraumatic Stress Disorders
Keywords: Post-traumatic stress disorder
sleep disturbance
insomnia
cytokines
anxiety
traumatic event
memory
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2012-05-24
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in Symptoms of Post-Traumatic Stress Disorder (PTSD) Between Baseline and Week 12
timeFrame: Between Baseline and Week 12
Secondary outcomes:
measure: Total Score on the Pittsburgh Sleep Quality Index With Post-Traumatic Stress Disorder Addendum (PSQI)
timeFrame: Changes in total score between Baseline and Week 12 (range of 0 to 21 worse)
measure: Changes in Emotional Bias Memory Encoding Between Baseline and Week 12
timeFrame: Baseline and week 12
measure: Cytokine Inflammatory Markers
timeFrame: Week 12
measure: Cytokine Inflammatory Marker on Interleukin-2
timeFrame: Week 12
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Center for Anxiety and Traumatic Stress Disorders at Rush
state: Illinois
Study officials:
affiliation: Rush University Medical Center
name: Mark Pollack, MD
role: PRINCIPAL_INVESTIGATOR
References: