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

Completed · Phase 4 · Has a placebo group

Conditions studied: Post-Traumatic Stress Disorders

In brief

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.

Key facts

Study ID

NCT00120250

Run by

Massachusetts General Hospital

People needed

27

Starts

2005-06-01

Expected to finish

2008-06-01

Last updated by the study team

2016-04-26

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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