Eszopiclone for the Treatment of Posttraumatic Stress Disorder

Sponsor

Rush University Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT01605253

Collaborator

National Institute of Mental Health (NIMH) (NIH)

Enrollment

Location

Arms

Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Posttraumatic Stress Disorders	Drug: Eszopiclone Drug: Placebo	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

81 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

Eszopiclone for the Treatment of PTSD

Study Start Date :

Mar 1, 2012

Actual Primary Completion Date :

Dec 1, 2015

Actual Study Completion Date :

Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
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 Names: 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.

Arm

Intervention/Treatment

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 Names:

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.

Outcome Measures

Primary Outcome Measures

Symptoms of Posttraumatic Stress Disorder [16 weeks]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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