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

Lehigh Center for Clinical Research

Status and phase: Completed; Phase 4

Conditions: Insomnia

Treatments: Drug: Eszopiclone; Drug: Escitalopram; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00813735

ESRCO66

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 65 to 85 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

Eszopiclone

Experimental group

Description:

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

Treatment:

Drug: Escitalopram

Drug: Eszopiclone

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

Drug: Escitalopram