Eszopiclone for the Treatment of Posttraumatic Stress Disorder

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Rush University Medical Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Rush University Medical Center
ClinicalTrials.gov Identifier:
NCT01605253
First received: May 10, 2012
Last updated: October 20, 2014
Last verified: January 2014

May 10, 2012
October 20, 2014
March 2012
June 2015   (final data collection date for primary outcome measure)
Symptoms of Posttraumatic Stress Disorder [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01605253 on ClinicalTrials.gov Archive Site
  • Sleep disturbance [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    Total sleep time, sleep latency, and number of awakenings.
  • Memory recall bias [ Time Frame: Baseline and week 12 (pre and post treatment) ] [ Designated as safety issue: No ]
  • Inflammatory markers (cytokines) [ Time Frame: Baseline and week 12 (pre and post treatment) ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Eszopiclone for the Treatment of Posttraumatic Stress Disorder
Eszopiclone for the Treatment of PTSD

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Posttraumatic Stress Disorders
  • 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.
    Other Name: Lunesta®
  • Drug: Placebo
    The placebo used in this study looks exactly like eszopiclone but contains no active ingredients.
  • 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.
    Intervention: Drug: Eszopiclone
  • 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.
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
June 2015
June 2015   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact: Elizabeth Kaiser, M.A 312-563-6687 ext 36687 Elizabeth_Kaiser@rush.edu
Contact: Sheila M Dowd, PhD 312-942-7281 ext 27281 sheila_dowd@rush.edu
United States
 
NCT01605253
1R34MH091338-01A1, 1R34MH091338-01A1
Yes
Rush University Medical Center
Rush University Medical Center
National Institute of Mental Health (NIMH)
Principal Investigator: Mark Pollack, MD Rush University Medical Center
Rush University Medical Center
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP