Insomnia
Conditions
Keywords
Insomnia, Major Depression, Geriatric
Brief summary
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.
Detailed description
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.
Interventions
DRUGEszopiclone
Eszopiclone 2mg daily at bedtime
DRUGPlacebo
Placebo daily at bedtime
DRUGEscitalopram
Escitalopram 10mg or 20mg
Sponsors
Sumitomo Pharma America, Inc.
Lehigh Center for Clinical Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
65 Years to 85 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in total sleep time from baseline to final visit | from baseline to final visit |
Secondary
| Measure | Time frame |
|---|---|
| change in sleep latency from baseline to final visit | from baseline to final visit |
| Change in HAMD from baseline to final visit | from baseline to final visit |
| vitals: BP,pulse,temperature,weight,assess AE's/SAE's | every visit |
| Change in CGI-S, CGI-I from baseline to final visit | baseline to final visit |
| labs (CBC,urinalysis,TSH,Chemprofile,drugscreen),height | visit 1 |
| Change in ISI from baseline to final visit | baseline to final visit |
Countries
United States
Outcome results
None listed