Eszopiclone Co-Administered With Escitalopram for Insomnia in Elderly Adults With Major Depressive Disorder
NCT00813735 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2012-10-03
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.
Conditions
Interventions
- DRUG
-
Eszopiclone
Eszopiclone 2mg daily at bedtime
- DRUG
-
Placebo daily at bedtime
- DRUG
-
Escitalopram
Escitalopram 10mg or 20mg
Sponsors & Collaborators
-
Sumitomo Pharma America, Inc.
collaborator INDUSTRY -
Lehigh Center for Clinical Research
lead OTHER
Principal Investigators
-
Paul K Gross · Lehigh Center for Clinical Research
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 65 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2006-09-30
- Primary Completion
- 2009-03-31
- Completion
- 2009-04-30
Countries
- United States
Study Locations
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