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Eszopiclone for Sleep Disturbance and Nightmares in Post-Traumatic Stress Disorder

Information source: Massachusetts General Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Post-Traumatic Stress Disorders

Intervention: Eszopiclone (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Massachusetts General Hospital

Official(s) and/or principal investigator(s):
Mark Pollack, M.D., Principal Investigator, Affiliation: Massachusetts General Hospital

Summary

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.

Clinical Details

Official title: Eszopiclone for Sleep Disturbance and Nightmares in Post-Traumatic Stress Disorder

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

Short PTSD Rating Interview (SPRINT)

Pittsburgh Sleep Quality Index (PSQI)

Secondary outcome:

Sleep Latency

Total Sleep Time

Clinician-Administered PTSD Scale (CAPS)

Detailed description: 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

Minimum age: 18 Years. Maximum age: 64 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Massachusetts General Hospital, Boston, Massachusetts 02114, United States
Additional Information

Official Website for the Center for Anxiety and Traumatic Stress Disorders

Starting date: June 2005
Last updated: December 26, 2013

Page last updated: August 23, 2015

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