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

Phase 4

Completed

• Conditions: Insomnia
• Interventions: Drug: Eszopiclone; Drug: Placebo; Drug: Escitalopram

• Registration Number: NCT00813735
• Lead Sponsor: Lehigh Center for Clinical Research

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.

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 Timeline

• Study Start: 2006-09
• Study First Submitted: 2008-12-22
• Study First Submitted QC: 2008-12-22
• Study First Posted: 2008-12-23
• Primary Completion: 2009-03
• Study Completion: 2009-04
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-02
• Last Update Posted: 2012-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Eszopiclone	Eszopiclone	Drug: Eszopiclone 2mg, Drug: Escitalopram 10mg or 20mg
Eszopiclone	Escitalopram	Drug: Eszopiclone 2mg, Drug: Escitalopram 10mg or 20mg
Placebo	Placebo	Drug: Placebo, Drug: Escitalopram 10mg or 20mg
Placebo	Escitalopram	Drug: Placebo, Drug: Escitalopram 10mg or 20mg

Primary Outcome Measures

Name	Time	Method
Change in total sleep time from baseline to final visit	from baseline to final visit

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Lehigh Center for Clinical Research; 🇺🇸 Allentown, Pennsylvania, United States