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

• Status: Completed
• Trial end date: 2008-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Treatments: Eszopiclone

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