Eszopiclone for the Treatment of Posttraumatic Stress Disorder

NCT01605253 | Completed Phase 4 Results DMC

• 1 other identifier: 1R34MH091338-01A1
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

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.

Conditions

Posttraumatic Stress Disorders

Keywords

Post-traumatic stress disorder; sleep disturbance; insomnia; cytokines; anxiety; traumatic event; memory

Outcome Measures

Primary Outcomes (1)

• Change in Symptoms of Post-Traumatic Stress Disorder (PTSD) Between Baseline and Week 12

  The Clinician-Administered PTSD Scale (CAPS) is a highly detailed measure of the presence and severity of the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-IV) Post-Traumatic Stress Disorder (PTSD) criteria. The severity score was calculated by adding up the frequency score (scale 0 = "none of the time" to 4 = "most or all of the time") and an intensity score (scale 0 = "none" to 4 = "extreme"), which can then be summed for all 17 symptom questions and/or for the three symptom clusters. Scores range from 0 to 136, where greater than or equal to 80 represents extreme PTSD symptomatology.

  Between Baseline and Week 12

Secondary Outcomes (4)

• Total Score on the Pittsburgh Sleep Quality Index With Post-Traumatic Stress Disorder Addendum (PSQI)

  Changes in total score between Baseline and Week 12 (range of 0 to 21 worse)

• Changes in Emotional Bias Memory Encoding Between Baseline and Week 12

  Baseline and week 12

• Cytokine Inflammatory Markers

  Week 12

• Cytokine Inflammatory Marker on Interleukin-2

  Week 12

Study Arms (2)

Eszopiclone

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Eszopiclone DRUG

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.

Also known as: Lunesta®

Eszopiclone

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Rush University Medical Center: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Center for Anxiety and Traumatic Stress Disorders at Rush

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Parasomnias; Sleep Initiation and Maintenance Disorders; Anxiety Disorders

Interventions

Eszopiclone

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Sleep Wake Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines; Pyridines

Results Point of Contact

• Title: Mark Pollack, MD
• Organization: Rush University Medical Center

mark_pollack@rush.edu

3129425372

Study Officials

• Mark Pollack, MD

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2012
• First Posted: May 24, 2012
• Study Start: March 1, 2012
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: December 23, 2022
• Results First Posted: December 23, 2022

Record last verified: 2022-11

Locations

US (1)