Eszopiclone for the Treatment of Posttraumatic Stress Disorder
| Status: | Completed |
|---|---|
| Conditions: | Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 11/19/2017 |
| Start Date: | March 2012 |
| End Date: | December 2015 |
Eszopiclone for the Treatment of PTSD
The purpose of this study is to determine if eszopiclone relative to placebo (sugar pill) is
effective and tolerable for people with posttraumatic stress disorder (PTSD)-related sleep
disturbance. The investigators will also examine the impact of treatment on sleep patterns,
memory recall bias, and level of inflammatory markers (cytokines). The investigators predict
eszopiclone will lead to greater improvement than placebo in measures of PTSD symptoms,
memory recall bias, and level of inflammatory markers.
effective and tolerable for people with posttraumatic stress disorder (PTSD)-related sleep
disturbance. The investigators will also examine the impact of treatment on sleep patterns,
memory recall bias, and level of inflammatory markers (cytokines). The investigators predict
eszopiclone will lead to greater improvement than placebo in measures of PTSD symptoms,
memory recall bias, and level of inflammatory markers.
Inclusion Criteria:
- Male or female outpatients age 18-65 with a primary diagnosis of PTSD and associated
sleep disturbance
- Good physical health
- Willingness and ability to comply with the requirements of the study protocol
Exclusion Criteria:
- Women pregnant, lactating, or of childbearing potential not using medically accepted
contraception
- Concurrent use of other psychotropic medications at least two weeks prior to baseline
- Concurrent use of other anti-inflammatory medications or anti-cytokine medications. If
used on an as-needed (PRN) basis, subjects may enter the study, but will be excluded
from cytokine analyses
- Concurrent use of beta-blockers less than one month prior to baseline
- Serious medical illness or instability for which hospitalization may be likely within
the next year
- Seizure disorders with the exception of a history of febrile seizures if they occurred
during childhood
- Sleep apnea or restless leg syndrome
- Concurrent psychotherapy initiated within 3 months of randomization or ongoing
psychotherapy of any duration directed specifically toward treatment of PTSD and/or
sleep disturbance
- Patients with significant suicidal ideation
- Current legal actions related to trauma or an ongoing relationship with assailant
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