Trial | NCT00813735  Report issue

Official Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    60
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 Started
Sep 30
2006
Primary Completion
Mar 31
2009
Study Completion
Apr 30
2009
Last Update
Oct 03
2012
Estimate

Drug Eszopiclone

Eszopiclone 2mg daily at bedtime

  • Other names: Escitalopram 10mg or 20mg daily in the AM

Drug Placebo

Placebo daily at bedtime

  • Other names: Escitalopram 10mg or 20mg daily in the AM

Drug Escitalopram

Escitalopram 10mg or 20mg

Eszopiclone Experimental

Drug: Eszopiclone 2mg, Drug: Escitalopram 10mg or 20mg

Placebo Placebo Comparator

Drug: Placebo, Drug: Escitalopram 10mg or 20mg

Criteria 

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
No Results Posted