Eszopiclone Co-Administered With Escitalopram for Insomnia in Elderly Adults With Major Depressive Disorder
Information source: Lehigh Center for Clinical Research
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Insomnia
Intervention: Eszopiclone (Drug); Placebo (Drug); Escitalopram (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Lehigh Center for Clinical Research Official(s) and/or principal investigator(s):
Paul K Gross, Principal Investigator, Affiliation: Lehigh Center for Clinical Research
Overall contact:
Paul K. Gross, MD, Phone: 610-820-0342, Email: pgross@lehighcenter.com
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.
Clinical Details
Official title: Eszopiclone Co-Administered With Escitalopram for Insomnia in Elderly Adults With Major Depressive Disorder
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Change in total sleep time from baseline to final visit
Secondary outcome: change in sleep latency from baseline to final visitChange in HAMD from baseline to final visit Change in ISI from baseline to final visit Change in CGI-S, CGI-I from baseline to final visit labs (CBC,urinalysis,TSH,Chemprofile,drugscreen),height vitals: BP,pulse,temperature,weight,assess AE's/SAE's
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.
Eligibility
Minimum age: 65 Years.
Maximum age: 85 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Paul K. Gross, MD, Phone: 610-820-0342, Email: pgross@lehighcenter.com
Lehigh Center for Clinical Research, Allentown, Pennsylvania 18104, United States; Recruiting
Gross, MD, Phone: 610-820-0342, Email: pgross@lehighcenter.com
Rose Nourse, RN,CCRC, Phone: 610-820-0342, Email: rnourse@lehighcenter.com
Paul K Gross, MD, Principal Investigator
Additional Information
Starting date: September 2006
Ending date: February 2009
Last updated: December 22, 2008
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