Clinical trial NCT00813735: Eszopiclone Co-Administered With Escitalopram for Insomnia in Elderly Adults With Major Depressive Disorder
Official title: Eszopiclone Co-Administered With Escitalopram for Insomnia in Elderly Adults With Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Insomnia
Keywords: Insomnia
Major Depression
Geriatric
Lead sponsor: Lehigh Center for Clinical Research
Sponsor class: OTHER
Collaborators: name: Sumitomo Pharma America, Inc.
First posted: 2008-12-23
Enrollment: 60
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Change in total sleep time from baseline to final visit
timeFrame: from baseline to final visit
Secondary outcomes:
measure: change in sleep latency from baseline to final visit
timeFrame: from baseline to final visit
measure: Change in HAMD from baseline to final visit
timeFrame: from baseline to final visit
measure: Change in ISI from baseline to final visit
timeFrame: baseline to final visit
measure: Change in CGI-S, CGI-I from baseline to final visit
timeFrame: baseline to final visit
measure: labs (CBC,urinalysis,TSH,Chemprofile,drugscreen),height
timeFrame: visit 1
measure: vitals: BP,pulse,temperature,weight,assess AE's/SAE's
timeFrame: every visit
Other outcomes:
Locations:
city: Allentown
country: United States
facility: Lehigh Center for Clinical Research
state: Pennsylvania
Study officials:
affiliation: Lehigh Center for Clinical Research
name: Paul K Gross
role: PRINCIPAL_INVESTIGATOR
References: