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

Sponsor:	Lehigh Center for Clinical Research
Collaborator:	Sunovion
Information provided by:	Lehigh Center for Clinical Research
ClinicalTrials.gov Identifier:	NCT00813735

Purpose

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.

Condition	Intervention	Phase
Insomnia	Drug: Eszopiclone Drug: Placebo Drug: Escitalopram	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	Eszopiclone Co-Administered With Escitalopram for Insomnia in Elderly Adults With Major Depressive Disorder

Resource links provided by NLM:

MedlinePlus related topics: Depression

Drug Information available for: Benzetimide Dexetimide Citalopram hydrobromide Citalopram Escitalopram Eszopiclone Escitalopram oxalate

U.S. FDA Resources

Further study details as provided by Lehigh Center for Clinical Research:

Primary Outcome Measures:

Change in total sleep time from baseline to final visit [ Time Frame: from baseline to final visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

change in sleep latency from baseline to final visit [ Time Frame: from baseline to final visit ] [ Designated as safety issue: No ]
Change in HAMD from baseline to final visit [ Time Frame: from baseline to final visit ] [ Designated as safety issue: No ]
Change in ISI from baseline to final visit [ Time Frame: baseline to final visit ] [ Designated as safety issue: No ]
Change in CGI-S, CGI-I from baseline to final visit [ Time Frame: baseline to final visit ] [ Designated as safety issue: No ]
labs (CBC,urinalysis,TSH,Chemprofile,drugscreen),height [ Time Frame: visit 1 ] [ Designated as safety issue: Yes ]
vitals: BP,pulse,temperature,weight,assess AE's/SAE's [ Time Frame: every visit ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	60
Study Start Date:	September 2006
Study Completion Date:	April 2009
Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Eszopiclone Drug: Eszopiclone 2mg, Drug: Escitalopram 10mg or 20mg	Drug: Eszopiclone Eszopiclone 2mg daily at bedtime Other Name: Escitalopram 10mg or 20mg daily in the AM Drug: Escitalopram Escitalopram 10mg or 20mg
Placebo Comparator: Placebo Drug: Placebo, Drug: Escitalopram 10mg or 20mg	Drug: Placebo Placebo daily at bedtime Other Name: Escitalopram 10mg or 20mg daily in the AM Drug: Escitalopram Escitalopram 10mg or 20mg

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

Ages Eligible for Study:	65 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00813735

Locations

United States, Pennsylvania
Lehigh Center for Clinical Research
Allentown, Pennsylvania, United States, 18104

Sponsors and Collaborators

Lehigh Center for Clinical Research

Sunovion

Investigators

Principal Investigator:

Paul K Gross

Lehigh Center for Clinical Research

More Information

No publications provided

Responsible Party:	Paul K. Gross, MD, Lehigh Center for Clinical Research
ClinicalTrials.gov Identifier:	NCT00813735 History of Changes
Other Study ID Numbers:	ESRCO66
Study First Received:	December 22, 2008
Last Updated:	October 8, 2009
Health Authority:	United States: Institutional Review Board

Keywords provided by Lehigh Center for Clinical Research:

Insomnia
Major Depression
Geriatric

Additional relevant MeSH terms:

Depressive Disorder
Depression
Depressive Disorder, Major
Sleep Initiation and Maintenance Disorders
Mood Disorders
Mental Disorders
Behavioral Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Dexetimide
Citalopram
Eszopiclone
Antiparkinson Agents

Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antidepressive Agents, Second-Generation
Antidepressive Agents

ClinicalTrials.gov processed this record on February 09, 2012