Eszopiclone Co-Administered With Escitalopram for Insomnia in Elderly Adults With Major Depressive Disorder

Study Overview
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Brief Summary
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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
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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.

Official Title
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Eszopiclone Co-Administered With Escitalopram for Insomnia in Elderly Adults With Major Depressive Disorder

Conditions
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Insomnia

Intervention / Treatment
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* Drug: Eszopiclone
* Drug: Placebo
* Drug: Escitalopram


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Eszopiclone<br>Drug: Eszopiclone 2mg, Drug: Escitalopram 10mg or 20mg | Drug: Eszopiclone<br>* Eszopiclone 2mg daily at bedtime<br>* Other names: Escitalopram 10mg or 20mg daily in the AM;Drug: Escitalopram<br>* Escitalopram 10mg or 20mg<br>|
| Placebo Comparator: Placebo<br>Drug: Placebo, Drug: Escitalopram 10mg or 20mg | Drug: Placebo<br>* Placebo daily at bedtime<br>* Other names: Escitalopram 10mg or 20mg daily in the AM;Drug: Escitalopram<br>* Escitalopram 10mg or 20mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in total sleep time from baseline to final visit |  | from baseline to final visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 
| Change in ISI from baseline to final visit |  | baseline to final 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 | 
| vitals: BP,pulse,temperature,weight,assess AE's/SAE's |  | every visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Insomnia, Major Depression, Geriatric