Status:
COMPLETED
Eszopiclone Co-Administered With Escitalopram for Insomnia in Elderly Adults With Major Depressive Disorder
Lead Sponsor:
Lehigh Center for Clinical Research
Collaborating Sponsors:
Sumitomo Pharma America, Inc.
Conditions:
Insomnia
Eligibility:
All Genders
65-85 years
Phase:
PHASE4
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 dis...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00813735
Start Date
September 1 2006
End Date
April 1 2009
Last Update
October 3 2012
Active Locations (1)
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1
Lehigh Center for Clinical Research
Allentown, Pennsylvania, United States, 18104