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Eszopiclone for the Treatment of Posttraumatic Stress Disorder

This study has been completed.
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Rush University Medical Center
ClinicalTrials.gov Identifier:
NCT01605253
First received: May 10, 2012
Last updated: April 14, 2016
Last verified: May 2015
  Purpose
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.

Condition Intervention Phase
Posttraumatic Stress Disorders
Drug: Eszopiclone
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Eszopiclone for the Treatment of PTSD

Resource links provided by NLM:


Further study details as provided by Rush University Medical Center:

Primary Outcome Measures:
  • Symptoms of Posttraumatic Stress Disorder [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 81
Study Start Date: March 2012
Study Completion Date: December 2015
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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®
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.
Drug: Placebo
The placebo used in this study looks exactly like eszopiclone but contains no active ingredients.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01605253

Locations
United States, Illinois
Center for Anxiety and Traumatic Stress Disorders at Rush
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
Rush University Medical Center
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Mark Pollack, MD Rush University Medical Center
  More Information

Responsible Party: Rush University Medical Center
ClinicalTrials.gov Identifier: NCT01605253     History of Changes
Other Study ID Numbers: 1R34MH091338-01A1 
Study First Received: May 10, 2012
Last Updated: April 14, 2016
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by Rush University Medical Center:
Post-traumatic stress disorder
sleep disturbance
insomnia
cytokines
anxiety
traumatic event
memory

Additional relevant MeSH terms:
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders
Eszopiclone
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 29, 2016