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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
Eszopiclone 2mg daily at bedtime
Placebo daily at bedtime
Escitalopram 10mg or 20mg
Lehigh Center for Clinical Research
Allentown, Pennsylvania, United States
Change in total sleep time from baseline to final visit
Time frame: from baseline to final visit
change in sleep latency from baseline to final visit
Time frame: from baseline to final visit
Change in HAMD from baseline to final visit
Time frame: from baseline to final visit
Change in ISI from baseline to final visit
Time frame: baseline to final visit
Change in CGI-S, CGI-I from baseline to final visit
Time frame: baseline to final visit
labs (CBC,urinalysis,TSH,Chemprofile,drugscreen),height
Time frame: visit 1
vitals: BP,pulse,temperature,weight,assess AE's/SAE's
Time frame: every visit
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