Eszopiclone for the Treatment of Posttraumatic Stress Disorder

Rush

Status and phase: Completed; Phase 4

Conditions: Posttraumatic Stress Disorders

Treatments: Drug: Eszopiclone; Drug: Placebo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01605253

1R34MH091338-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 81 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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81 participants in 2 patient groups, including a placebo group

Eszopiclone

Active Comparator group

Description:

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.

Treatment:

Drug: Eszopiclone

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo