Eszopiclone for the Treatment of Posttraumatic Stress Disorder

Completed · Phase 4 · Has a placebo group

Conditions studied: Posttraumatic Stress Disorders

In brief

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.

Key facts

Study ID

NCT01605253

Run by

Rush University Medical Center

People needed

81

Starts

2012-03-01

Expected to finish

2015-12-01

Last updated by the study team

2022-12-23

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Center for Anxiety and Traumatic Stress Disorders at Rush — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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