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

This study has been completed.
Sponsor:
Collaborator:
Sunovion
Information provided by (Responsible Party):
Lehigh Center for Clinical Research
ClinicalTrials.gov Identifier:
NCT00813735
First received: December 22, 2008
Last updated: October 2, 2012
Last verified: October 2012
  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 4

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:


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 ]

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: 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 2, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Lehigh Center for Clinical Research:
Insomnia
Major Depression
Geriatric

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mental Disorders
Mood Disorders
Citalopram
Dexetimide
Eszopiclone
Anti-Dyskinesia Agents
Antidepressive Agents
Antidepressive Agents, Second-Generation
Antiparkinson Agents
Autonomic Agents
Central Nervous System Agents
Central Nervous System Depressants
Cholinergic Agents
Cholinergic Antagonists
Hypnotics and Sedatives
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Parasympatholytics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Uptake Inhibitors

ClinicalTrials.gov processed this record on October 23, 2014