Eszopiclone Co-Administered With Escitalopram for Insomnia in Elderly Adults With Major Depressive Disorder
| Status: | Completed |
|---|---|
| Conditions: | Depression, Depression, Insomnia Sleep Studies, Major Depression Disorder (MDD) |
| Therapuetic Areas: | Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 65 - 85 |
| Updated: | 10/14/2017 |
| Start Date: | September 2006 |
| End Date: | April 2009 |
Research has established the incidence of insomnia increases with age and the possible causes
contributing to sleep problems in the elderly are still being explored and debated. Older
adults use a disproportionately large share of sleep aids with non-prescription sleep aid use
having increased over the past decade. This study is a double blind safety and effectiveness
trial examining the response of eszopiclone co-administered with escitalopram for the
treatment of insomnia symptoms in geriatric depressed adults with insomnia symptoms.
contributing to sleep problems in the elderly are still being explored and debated. Older
adults use a disproportionately large share of sleep aids with non-prescription sleep aid use
having increased over the past decade. This study is a double blind safety and effectiveness
trial examining the response of eszopiclone co-administered with escitalopram for the
treatment of insomnia symptoms in geriatric depressed adults with insomnia symptoms.
This is a double-blind, randomized, placebo-controlled, parallel-group study. There are two
groups of subjects with Major Depressive Disorder and insomnia symptoms randomized to
treatment either with eszopicone 2mg or placebo daily at bedtime for 14 weeks beginning at
visit 2. Also, all subjects receive open label treatment with escitalopram 10 or 20mg daily
in the morning. Safety and efficacy is evaluated as well as rating scales and patient sleep
diaries.
groups of subjects with Major Depressive Disorder and insomnia symptoms randomized to
treatment either with eszopicone 2mg or placebo daily at bedtime for 14 weeks beginning at
visit 2. Also, all subjects receive open label treatment with escitalopram 10 or 20mg daily
in the morning. Safety and efficacy is evaluated as well as rating scales and patient sleep
diaries.
Inclusion Criteria:
- Diagnosis of MDD, HAMD score 20 or greater at screening and baseline, total sleep time
less than 6 hours at screening and baseline, ISI 15 or greater at screening and
baseline
Exclusion Criteria:
- May not use any other psychoactive drugs/psychotropics during study, may not have any
type of dementia, may not have any significant/unstable medical problems, no
nightshift work permitted, no current seizure disorders/head injuries
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