Phase 4
Completed N=25
Eszopiclone for the Treatment of Posttraumatic Stress Disorder
Posttraumatic Stress Disorders
Source: ClinicalTrials.gov NCT01605253 ↗
Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Dec 2022
Primary outcomePrimary: Change in Symptoms of Post-Traumatic Stress Disorder (PTSD) Between Baseline and Week 12 — -23; -20 units on a scale
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Symptoms of Post-Traumatic Stress Disorder (PTSD) Between Baseline and Week 12 |
-23; -20 | — |
| SECONDARY Total Score on the Pittsburgh Sleep Quality Index With Post-Traumatic Stress Disorder Addendum (PSQI) |
-4.13; -3.33 | — |
| SECONDARY Changes in Emotional Bias Memory Encoding Between Baseline and Week 12 |
93; 102 | — |
| SECONDARY Cytokine Inflammatory Markers |
3.62; -1.55; -0.10; 0.30; 1.29; -0.08 | — |
| SECONDARY Cytokine Inflammatory Marker on Interleukin-2 |
1.67; -0.07 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01605253). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.