Status:
COMPLETED
Eszopiclone for Sleep Disturbance and Nightmares in Post-Traumatic Stress Disorder
Lead Sponsor:
Massachusetts General Hospital
Conditions:
Post-Traumatic Stress Disorders
Eligibility:
All Genders
18-64 years
Phase:
PHASE4
Brief 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 ...
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 av...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT00120250
Start Date
June 1 2005
End Date
June 1 2008
Last Update
April 26 2016
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114