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Completed

NCT Number: NCT00813735

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

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.

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Key information

Conditions

Insomnia Depressive Disorder Depressive Disorder, Major Dyssomnias Mental Disorders Mood Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

65 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Lehigh Center for Clinical Research

Allentown, Pennsylvania, 18104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Eszopiclone

Drug

Eszopiclone 2mg daily at bedtime

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

Placebo

Drug

Placebo daily at bedtime

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

Escitalopram

Drug

Escitalopram 10mg or 20mg

Primary outcomes

  1. Change in total sleep time from baseline to final visit

    Time frame: from baseline to final visit

Secondary outcomes

  1. change in sleep latency from baseline to final visit

    Time frame: from baseline to final visit

  2. Change in HAMD from baseline to final visit

    Time frame: from baseline to final visit

  3. Change in ISI from baseline to final visit

    Time frame: baseline to final visit

  4. Change in CGI-S, CGI-I from baseline to final visit

    Time frame: baseline to final visit

  5. labs (CBC,urinalysis,TSH,Chemprofile,drugscreen),height

    Time frame: visit 1

  6. vitals: BP,pulse,temperature,weight,assess AE's/SAE's

    Time frame: every visit

Sponsors and collaborators

Lead sponsor

Lehigh Center for Clinical Research

Other

Collaborators

  • Sumitomo Pharma America, Inc.

Registry information

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Dec 23, 2008
Registry last updated
Oct 3, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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