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

NCT00813735 | Completed Phase 4 DMC

• 1 other identifier: ESRCO66
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Insomnia

Keywords

Insomnia; Major Depression; Geriatric

Outcome Measures

Primary Outcomes (1)

• Change in total sleep time from baseline to final visit

  from baseline to final visit

Secondary Outcomes (6)

• change in sleep latency from baseline to final visit

  from baseline to final visit

• Change in HAMD from baseline to final visit

  from baseline to final visit

• Change in ISI from baseline to final visit

  baseline to final visit

• Change in CGI-S, CGI-I from baseline to final visit

  baseline to final visit

• labs (CBC,urinalysis,TSH,Chemprofile,drugscreen),height

  visit 1

Study Arms (2)

Eszopiclone

EXPERIMENTAL

Drug: Eszopiclone 2mg, Drug: Escitalopram 10mg or 20mg

Drug: Eszopiclone; Drug: Escitalopram

Placebo

PLACEBO COMPARATOR

Drug: Placebo, Drug: Escitalopram 10mg or 20mg

Drug: Placebo; Drug: Escitalopram

Interventions

Eszopiclone DRUG

Eszopiclone 2mg daily at bedtime

Also known as: Escitalopram 10mg or 20mg daily in the AM

Eszopiclone

Placebo DRUG

Placebo daily at bedtime

Also known as: Escitalopram 10mg or 20mg daily in the AM

Placebo

Escitalopram DRUG

Escitalopram 10mg or 20mg

Eszopiclone; Placebo

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lehigh Center for Clinical Research: lead
• Sumitomo Pharma America, Inc.: collaborator

Study Sites (1)

Lehigh Center for Clinical Research

Allentown, Pennsylvania, 18104, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Depressive Disorder, Major

Interventions

Eszopiclone; Escitalopram

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Depressive Disorder; Mood Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines; Pyridines; Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Paul K Gross

  Lehigh Center for Clinical Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2008
• First Posted: December 23, 2008
• Study Start: September 1, 2006
• Primary Completion: March 1, 2009
• Study Completion: April 1, 2009
• Last Updated: October 3, 2012

Record last verified: 2012-10

Locations

US (1)