Official Title: “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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: December 2008

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.

Intervention(s) in this Clinical Trial

• Drug: Eszopiclone
  • Eszopiclone 2mg daily at bedtime
• Drug: Placebo
  • Placebo daily at bedtime
• Drug: Escitalopram
  • Escitalopram 10mg or 20mg

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Eszopiclone
  • Drug: Eszopiclone 2mg, Drug: Escitalopram 10mg or 20mg
• Placebo Comparator: Placebo
  • Drug: Placebo, Drug: Escitalopram 10mg or 20mg

Primary Measures

• Change in total sleep time from baseline to final visit
  • Time Frame: from baseline to final visit
    Safety Issue?: No

Secondary Measures

• change in sleep latency from baseline to final visit
  • Time Frame: from baseline to final visit
    Safety Issue?: No
• Change in HAMD from baseline to final visit
  • Time Frame: from baseline to final visit
    Safety Issue?: No
• Change in ISI from baseline to final visit
  • Time Frame: baseline to final visit
    Safety Issue?: No
• Change in CGI-S, CGI-I from baseline to final visit
  • Time Frame: baseline to final visit
    Safety Issue?: No
• labs (CBC,urinalysis,TSH,Chemprofile,drugscreen),height
  • Time Frame: visit 1
    Safety Issue?: Yes
• vitals: BP,pulse,temperature,weight,assess AE's/SAE's
  • Time Frame: every visit
    Safety Issue?: 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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 65 Years

Maximum Age for this Clinical Trial: 85 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Lehigh Center for Clinical Research

Overall Clinical Trial Officials and Contacts

Paul K Gross Principal Investigator Lehigh Center for Clinical Research  

Overall Contact: Paul K. Gross, MD 610-820-0342 pgross@lehighcenter.com

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00813735

Study ID Number: ESRCO66

ClinicalTrials.gov Identifier: NCT00813735

Health Authority: United States: Institutional Review Board