CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 81 enrolled
Drug / intervention
Eszopiclone +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01605253
NCT01605253Phase 4Completed

Eszopiclone for the Treatment of PTSD

Rush University Medical Center·interventional·Posted May 24, 2012·Updated Dec 23, 2022

In Brief

A Phase 4 clinical trial evaluating Eszopiclone and Placebo for Posttraumatic Stress Disorders. Completed, enrolled 81 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMay 24, 2012
Enrollment StartMar 1, 2012
Primary CompletionDec 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 14.1 years ago

Interventions

Eszopiclonedrug

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.

Placebodrug

The placebo used in this study looks exactly like eszopiclone but contains no active ingredients.