Eszopiclone for the Treatment of Posttraumatic Stress Disorder

Overview

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.

Full Title of Study: “Eszopiclone for the Treatment of PTSD”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: December 2015

Interventions

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

Arms, Groups and Cohorts

  • Active Comparator: 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.
  • Placebo Comparator: 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.

Clinical Trial Outcome Measures

Primary Measures

  • Symptoms of Posttraumatic Stress Disorder
    • Time Frame: 16 weeks

Secondary Measures

  • Sleep disturbance
    • Time Frame: 16 weeks
    • Total sleep time, sleep latency, and number of awakenings.
  • Memory recall bias
    • Time Frame: Baseline and week 12 (pre and post treatment)
  • Inflammatory markers (cytokines)
    • Time Frame: Baseline and week 12 (pre and post treatment)

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Rush University Medical Center
  • Collaborator
    • National Institute of Mental Health (NIMH)
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Mark Pollack, MD, Principal Investigator, Rush University Medical Center

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