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 LatencyTotal 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
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