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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00813735
Recruitment Status : Completed
First Posted : December 23, 2008
Last Update Posted : October 3, 2012
Sponsor:
Collaborator:
Sunovion
Information provided by (Responsible Party):
Lehigh Center for Clinical Research

Study Description
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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.

Condition or disease Intervention/treatment Phase
Insomnia Drug: Eszopiclone Drug: Placebo Drug: Escitalopram Phase 4

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Eszopiclone Co-Administered With Escitalopram for Insomnia in Elderly Adults With Major Depressive Disorder
Study Start Date : September 2006
Actual Primary Completion Date : March 2009
Actual Study Completion Date : April 2009

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Change in total sleep time from baseline to final visit [ Time Frame: from baseline to final visit ]

Secondary Outcome Measures :
  1. change in sleep latency from baseline to final visit [ Time Frame: from baseline to final visit ]
  2. Change in HAMD from baseline to final visit [ Time Frame: from baseline to final visit ]
  3. Change in ISI from baseline to final visit [ Time Frame: baseline to final visit ]
  4. Change in CGI-S, CGI-I from baseline to final visit [ Time Frame: baseline to final visit ]
  5. labs (CBC,urinalysis,TSH,Chemprofile,drugscreen),height [ Time Frame: visit 1 ]
  6. vitals: BP,pulse,temperature,weight,assess AE's/SAE's [ Time Frame: every visit ]

Eligibility Criteria
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Ages Eligible for Study:   65 Years to 85 Years   (Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00813735


Locations
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United States, Pennsylvania
Lehigh Center for Clinical Research
Allentown, Pennsylvania, United States, 18104
Sponsors and Collaborators
Lehigh Center for Clinical Research
Sunovion
Investigators
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Principal Investigator: Paul K Gross Lehigh Center for Clinical Research
More Information
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Responsible Party: Lehigh Center for Clinical Research
ClinicalTrials.gov Identifier: NCT00813735    
Other Study ID Numbers: ESRCO66
First Posted: December 23, 2008    Key Record Dates
Last Update Posted: October 3, 2012
Last Verified: October 2012
Keywords provided by Lehigh Center for Clinical Research:
Insomnia
Major Depression
Geriatric
Additional relevant MeSH terms:
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Sleep Initiation and Maintenance Disorders
Depressive Disorder
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Dexetimide
Eszopiclone
Citalopram
Escitalopram
Selective Serotonin Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
 Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents