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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mark H. Pollack, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00120250
First received: July 7, 2005
Last updated: December 26, 2013
Last verified: December 2013
  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

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Short PTSD Rating Interview (SPRINT) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    The SPRINT is a 8-item, clinician-administered scale assessing core and related symptoms of PTSD. Symptoms are rates on 5 point scales from 0 (not at all) to 4 (very much) where a higher value indicates a worse outcome.

  • Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    The PSQI is a 24-item, patient-administered scale that assess changes in sleep symptomatology. The total PSQI score ranges from 0 to 21 where a higher value indicates a worse sleep symptomatology.


Secondary Outcome Measures:
  • Sleep Latency [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Sleep Latency was derived from a subject-completed daily sleep diary.

  • Total Sleep Time [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Total Sleep Time was derived from a subject-completed daily sleep diary.

  • Clinician-Administered PTSD Scale (CAPS) [ Time Frame: Week 3 ] [ Designated as safety issue: No ]
    The CAPS is a highly detailed measure of the presence and severity of the DSM-IV PTSD criteria. The severity score was calculated by adding up the frequency score (scale 0 = "none of the time" to 4 = "most or all of the time") and an intensity score (scale 0 = "none" to 4 = "extreme"), which can then be summed for all 17 symptom questions and/or for the three symptom clusters. Scores range from 0 to 136, where greater than or equal to 80 represents extreme PTSD symptomatology. In this case, the total score for all 17 symptom questions, which is also the sum of the three symptom clusters, is used.


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)
Arms Assigned Interventions
Experimental: Eszopiclone
Subjects received 3mg eszopiclone nightly for 3 weeks, followed by a 1 week washout period, followed by 3 weeks of placebo, followed by another 1 week washout.
Drug: Eszopiclone
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
Placebo Comparator: Placebo
Subjects received placebo nightly for 3 weeks, followed by a 1 week washout period, followed by 3 weeks of 3mg eszopiclone, followed by another 1 week washout.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Publications:
Responsible Party: Mark H. Pollack, Grainger Professor and Chairman, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00120250     History of Changes
Other Study ID Numbers: 2005-P-000645
Study First Received: July 7, 2005
Results First Received: July 19, 2013
Last Updated: December 26, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
PTSD
Sleep disturbance
Eszopiclone
Double-blind
Crossover

Additional relevant MeSH terms:
Disease
Dyssomnias
Parasomnias
Sleep Disorders
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders
Nervous System Diseases
Neurologic Manifestations
Pathologic Processes
Signs and Symptoms
Eszopiclone
Central Nervous System Agents
Central Nervous System Depressants
Hypnotics and Sedatives
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014