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

Sponsors and Collaborators:	Lehigh Center for Clinical Research Sepracor, Inc.
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:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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
Estimated Study Completion Date:	February 2009
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Eszopiclone: Experimental Drug: Eszopiclone 2mg, Drug: Escitalopram 10mg or 20mg	Drug: Eszopiclone Eszopiclone 2mg daily at bedtime Drug: Escitalopram Escitalopram 10mg or 20mg
Placebo: Placebo Comparator Drug: Placebo, Drug: Escitalopram 10mg or 20mg	Drug: Placebo Placebo daily at bedtime 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

Contacts

Contact: Paul K. Gross, MD	610-820-0342	pgross@lehighcenter.com
Contact: Vince J. Gillen, BA	610-820-0342	vgillen@lehighcenter.com

Locations

United States, Pennsylvania
Lehigh Center for Clinical Research	Recruiting
Allentown, Pennsylvania, United States, 18104
Contact: Gross, MD 610-820-0342 pgross@lehighcenter.com
Contact: Rose Nourse, RN,CCRC 610-820-0342 rnourse@lehighcenter.com
Principal Investigator: Paul K Gross, MD

Sponsors and Collaborators

Lehigh Center for Clinical Research

Sepracor, Inc.

Investigators

Principal Investigator:

Paul K Gross

Lehigh Center for Clinical Research

More Information

No publications provided

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

Keywords provided by Lehigh Center for Clinical Research:

Insomnia
Major Depression
Geriatric

Study placed in the following topic categories:

Sleep Initiation and Maintenance Disorders
Neurotransmitter Agents
Depression
Cholinergic Antagonists
Psychotropic Drugs
Sleep Disorders
Dyssomnias
Depressive Disorder, Major
Cholinergic Agents
Depressive Disorder
Serotonin Uptake Inhibitors

Citalopram
Serotonin
Behavioral Symptoms
Sleep Disorders, Intrinsic
Muscarinic Antagonists
Mental Disorders
Mood Disorders
Peripheral Nervous System Agents
Antidepressive Agents, Second-Generation
Dexetimide
Antidepressive Agents

Additional relevant MeSH terms:

Sleep Initiation and Maintenance Disorders
Parasympatholytics
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Cholinergic Antagonists
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Psychotropic Drugs
Sleep Disorders
Antiparkinson Agents
Depressive Disorder, Major
Cholinergic Agents
Sleep Disorders, Intrinsic
Mental Disorders

Therapeutic Uses
Antidepressive Agents, Second-Generation
Dexetimide
Antidepressive Agents
Depression
Nervous System Diseases
Dyssomnias
Depressive Disorder
Serotonin Uptake Inhibitors
Citalopram
Pharmacologic Actions
Behavioral Symptoms
Muscarinic Antagonists
Serotonin Agents
Autonomic Agents

ClinicalTrials.gov processed this record on August 28, 2009