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

Sponsor:	Massachusetts General Hospital
Information provided by:	Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT00120250

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 IV

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

Resource links provided by NLM:

MedlinePlus related topics: Post-Traumatic Stress Disorder Sleep Disorders

Drug Information available for: Eszopiclone

U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:

Sleep latency [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Total sleep time [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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)

Intervention Details:

The total study duration is 8 weeks, with subjects receiving 3mg eszopiclone or placebo nightly for 3 weeks, followed by a 1 week washout period, followed by 3 weeks of the alternate condition, followed by another 1 week washout.

Other Name: Lunesta

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

Ages Eligible for Study:	18 Years to 64 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00120250

Locations

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

Sponsors and Collaborators

Massachusetts General Hospital

Investigators

Principal Investigator:

Mark Pollack, M.D.

Massachusetts General Hospital

More Information

Additional Information:

Official Website for the Center for Anxiety and Traumatic Stress Disorders This link exits the ClinicalTrials.gov site

Publications:

Pollack MH, Hoge EA, Worthington JJ, Moshier SJ, Wechsler RS, Brandes M, Simon NM. Eszopiclone for the treatment of posttraumatic stress disorder and associated insomnia: a randomized, double-blind, placebo-controlled trial. J Clin Psychiatry. 2011 Feb 22; [Epub ahead of print]

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 February 12, 2012