Eszopiclone for the Treatment of Posttraumatic Stress Disorder
This study is currently recruiting participants.
Verified May 2012 by Rush University Medical Center
Sponsor:
Rush University Medical Center
Collaborator:
Information provided by (Responsible Party):
Rush University Medical Center
ClinicalTrials.gov Identifier:
NCT01605253
First received: May 10, 2012
Last updated: May 22, 2012
Last verified: May 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Posttraumatic Stress Disorders |
Drug: Eszopiclone Drug: Placebo |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Eszopiclone for the Treatment of PTSD |
Resource links provided by NLM:
Further study details as provided by Rush University Medical Center:
Primary Outcome Measures:
- Symptoms of Posttraumatic Stress Disorder [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Sleep disturbance [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]Total sleep time, sleep latency, and number of awakenings.
- Memory recall bias [ Time Frame: Baseline and week 12 (pre and post treatment) ] [ Designated as safety issue: No ]
- Inflammatory markers (cytokines) [ Time Frame: Baseline and week 12 (pre and post treatment) ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 40 |
| Study Start Date: | March 2012 |
| Estimated Study Completion Date: | June 2014 |
| Estimated Primary Completion Date: | June 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Eszopiclone
The total study duration is 16 weeks, with subjects taking 3mg eszopiclone or placebo at bedtime for 12 weeks. There is one follow-up visit after the 12 week treatment phase.
|
Drug: Eszopiclone
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.
Other Name: Lunesta®
|
| Placebo Comparator: Placebo |
Drug: Placebo
The placebo used in this study looks exactly like eszopiclone but contains no active ingredients.
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01605253
Contacts
| Contact: Jennifer N Baumgartner, BA | 312-563-6687 ext 36687 | jennifer_baumgartner@rush.edu |
| Contact: Sheila M Dowd, PhD | 312-942-7281 ext 27281 | sheila_dowd@rush.edu |
Locations
| United States, Illinois | |
| Center for Anxiety and Traumatic Stress Disorders at Rush | Recruiting |
| Chicago, Illinois, United States, 60612 | |
| Contact: Jennifer N Baumgartner, BA 312-563-6687 ext 36687 jennifer_baumgartner@rush.edu | |
| Contact: Sheila M Dowd, PhD 312-942-7281 ext 27281 sheila_dowd@rush.edu | |
Sponsors and Collaborators
Rush University Medical Center
Investigators
| Principal Investigator: | Mark Pollack, MD | Rush University Medical Center |
More Information
No publications provided
| Responsible Party: | Rush University Medical Center |
| ClinicalTrials.gov Identifier: | NCT01605253 History of Changes |
| Other Study ID Numbers: | 1R34MH091338-01A1, 1R34MH091338-01A1 |
| Study First Received: | May 10, 2012 |
| Last Updated: | May 22, 2012 |
| Health Authority: | United States: Institutional Review Board United States: Federal Government |
Keywords provided by Rush University Medical Center:
|
Post-traumatic stress disorder sleep disturbance insomnia cytokines |
anxiety traumatic event memory |
Additional relevant MeSH terms:
|
Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Anxiety Disorders Mental Disorders Eszopiclone Hypnotics and Sedatives |
Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013