Eszopiclone for Sleep Disturbance and Nightmares in Post-Traumatic Stress Disorder
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Purpose
The purpose of this study is to obtain data investigating the safety and efficacy of eszopiclone for the treatment of post-traumatic stress disorder (PTSD)-related sleep disturbance and the impact of improved sleep with eszopiclone treatment on neuroendocrine correlates of PTSD. The investigators hypothesize that eszopiclone will be significantly more effective than placebo and well tolerated for PTSD-related sleep disturbance, improvement in sleep will be associated with improvement in overall PTSD symptoms, and patients with PTSD-related sleep disturbances will have abnormal levels of stress hormones.
| Condition | Intervention | Phase |
|---|---|---|
|
Post-Traumatic Stress Disorders |
Drug: Eszopiclone |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Eszopiclone for Sleep Disturbance and Nightmares in Post-Traumatic Stress Disorder |
- Sleep latency [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Total sleep time [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Symptoms of Posttraumatic Stress Disorder [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Sleep quality [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Quality of life [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 27 |
| Study Start Date: | June 2005 |
| Study Completion Date: | June 2008 |
| Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
-
Drug: Eszopiclone
Post-traumatic stress disorder (PTSD) is characterized by three symptom groupings: re-experiencing symptoms including flashbacks, nightmares, and intrusive memories; physiological hyperarousal; and avoidance symptoms. Of the three major categories of symptoms in PTSD listed by the Diagnostic and Statistical Manual of Mental Disorders, sleep-related problems are listed in two of them: difficulty falling asleep is considered an aspect of hyperarousal symptoms, and nightmares are a type of re-experiencing symptom. Both are found commonly in PTSD. Little is known about the relationship of neuroendocrine dysregulation in PTSD and sleep disturbance. It is possible that successful treatment of sleep disturbance in PTSD may alter an abnormal stress hormone pattern. The novel cyclopyrrolone hypnotic eszopiclone thus presents an intriguing opportunity to examine the treatment of sleep disturbances and nightmares in PTSD. This study will determine the safety, efficacy and impact on neuroendocrine parameters of eszopiclone compared to placebo for sleep disturbance and overall PTSD symptoms in individuals with PTSD and reported sleep disturbance.
Eligibility| Ages Eligible for Study: | 18 Years to 64 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Male or female outpatients 18-64 years of age with a primary diagnosis of PTSD as defined by DSM-IV criteria with associated sleep disturbance
Exclusion Criteria:
- Pregnant women, lactating women, and women of childbearing potential who are not using medically accepted forms of contraception.
- Concurrent use of other psychotropic medications, other than antidepressants at stable dose for at least 4 weeks prior to randomization
- Serious medical illness or instability
- Seizure disorders with the exception of a history of febrile seizures if they occurred during childhood
- Concurrent psychotherapy initiated within one month of randomization or ongoing psychotherapy of any duration directed specifically toward treatment of PTSD and/or sleep disturbance
- Diagnosis of schizophrenia, mental retardation, OCD, organic medical disorders or bipolar disorder, eating disorders in the past 6 months, alcohol or substance abuse in the past 3 months, or dependence within the past 6 months.
- Patients with significant suicidal ideation or who have enacted suicidal behaviors within 6 months prior to intake
Contacts and Locations| United States, Massachusetts | |
| Massachusetts General Hospital | |
| Boston, Massachusetts, United States, 02114 | |
| Principal Investigator: | Mark Pollack, M.D. | Massachusetts General Hospital |
More Information
Additional Information:
Publications:
| Responsible Party: | Mark Pollack, M.D., Center for Anxiety and Traumatic Stress Disorders |
| ClinicalTrials.gov Identifier: | NCT00120250 History of Changes |
| Other Study ID Numbers: | 2005-P-000645 |
| Study First Received: | July 7, 2005 |
| Last Updated: | July 21, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Massachusetts General Hospital:
|
PTSD Sleep disturbance Eszopiclone Double-blind Crossover |
Additional relevant MeSH terms:
|
Sleep Disorders Dyssomnias Parasomnias Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Nervous System Diseases Neurologic Manifestations Signs and Symptoms Mental Disorders |
Anxiety 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 October 16, 2012
