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

NCT ID: NCT00813735

Last Updated: 2012-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2009-04-30

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.

Conditions

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Insomnia

Keywords

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Insomnia Major Depression Geriatric

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Eszopiclone

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

Group Type EXPERIMENTAL

Eszopiclone

Intervention Type DRUG

Eszopiclone 2mg daily at bedtime

Escitalopram

Intervention Type DRUG

Escitalopram 10mg or 20mg

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo daily at bedtime

Escitalopram

Intervention Type DRUG

Escitalopram 10mg or 20mg

Interventions

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Eszopiclone

Eszopiclone 2mg daily at bedtime

Intervention Type DRUG

Placebo

Placebo daily at bedtime

Intervention Type DRUG

Escitalopram

Escitalopram 10mg or 20mg

Intervention Type DRUG

Other Intervention Names

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Escitalopram 10mg or 20mg daily in the AM Escitalopram 10mg or 20mg daily in the AM

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
Minimum Eligible Age

65 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sumitomo Pharma America, Inc.

INDUSTRY

Sponsor Role collaborator

Lehigh Center for Clinical Research

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Paul K Gross

Role: PRINCIPAL_INVESTIGATOR

Lehigh Center for Clinical Research

Locations

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Lehigh Center for Clinical Research

Allentown, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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ESRCO66

Identifier Type: -

Identifier Source: org_study_id