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

Sponsor

Lehigh Center for Clinical Research (Other)

Overall Status

Completed

CT.gov ID

NCT00813735

Collaborator

Sunovion (Industry)

Enrollment

Location

Arms

Duration (Months)

1.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Insomnia	Drug: Eszopiclone Drug: Placebo Drug: Escitalopram	Phase 4

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 2006

Actual Primary Completion Date :

Mar 1, 2009

Actual Study Completion Date :

Apr 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Eszopiclone Drug: Eszopiclone 2mg, Drug: Escitalopram 10mg or 20mg	Drug: Eszopiclone Eszopiclone 2mg daily at bedtime Other Names: Escitalopram 10mg or 20mg daily in the AM Drug: Escitalopram Escitalopram 10mg or 20mg
Placebo Comparator: Placebo Drug: Placebo, Drug: Escitalopram 10mg or 20mg	Drug: Placebo Placebo daily at bedtime Other Names: Escitalopram 10mg or 20mg daily in the AM Drug: Escitalopram Escitalopram 10mg or 20mg

Arm

Intervention/Treatment

Experimental: Eszopiclone

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

Drug: Eszopiclone

Eszopiclone 2mg daily at bedtime

Other Names:

Escitalopram 10mg or 20mg daily in the AM

Drug: Escitalopram

Escitalopram 10mg or 20mg

Placebo Comparator: Placebo

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

Drug: Placebo

Placebo daily at bedtime

Other Names:

Escitalopram 10mg or 20mg daily in the AM

Drug: Escitalopram

Escitalopram 10mg or 20mg

Outcome Measures

Primary Outcome Measures

Change in total sleep time from baseline to final visit [from baseline to final visit]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years to 85 Years

Sexes Eligible for Study:

All

Accepts 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