Eszopiclone Co-Administered With Escitalopram for Insomnia in Elderly Adults With Major Depressive Disorder

Insomnia Clinical Trial

Official title:

Eszopiclone Co-Administered With Escitalopram for Insomnia in Elderly Adults With Major Depressive Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00813735
• Other study ID #: ESRCO66
• Status: Completed
• Phase: Phase 4
• First received: December 22, 2008
• Last updated: October 2, 2012
• Start date: September 2006
• Est. completion date: April 2009

Study information

• Verified date: October 2012
• Source: Lehigh Center for Clinical Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

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

Locations

Country	Name	City	State
United States	Lehigh Center for Clinical Research	Allentown	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Lehigh Center for Clinical Research	Sunovion

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in total sleep time from baseline to final visit		from baseline to final visit
Secondary	change in sleep latency from baseline to final visit		from baseline to final visit
Secondary	Change in HAMD from baseline to final visit		from baseline to final visit
Secondary	Change in ISI from baseline to final visit		baseline to final visit
Secondary	Change in CGI-S, CGI-I from baseline to final visit		baseline to final visit
Secondary	labs (CBC,urinalysis,TSH,Chemprofile,drugscreen),height		visit 1
Secondary	vitals: BP,pulse,temperature,weight,assess AE's/SAE's		every visit