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

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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

Tracking Information
First Submitted Date  ICMJE December 22, 2008
First Posted Date  ICMJE December 23, 2008
Last Update Posted Date October 3, 2012
Study Start Date  ICMJE September 2006
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 22, 2008)
Change in total sleep time from baseline to final visit [ Time Frame: from baseline to final visit ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00813735 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 22, 2008)
  • change in sleep latency from baseline to final visit [ Time Frame: from baseline to final visit ]
  • Change in HAMD from baseline to final visit [ Time Frame: from baseline to final visit ]
  • Change in ISI from baseline to final visit [ Time Frame: baseline to final visit ]
  • Change in CGI-S, CGI-I from baseline to final visit [ Time Frame: baseline to final visit ]
  • labs (CBC,urinalysis,TSH,Chemprofile,drugscreen),height [ Time Frame: visit 1 ]
  • vitals: BP,pulse,temperature,weight,assess AE's/SAE's [ Time Frame: every visit ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Eszopiclone Co-Administered With Escitalopram for Insomnia in Elderly Adults With Major Depressive Disorder
Official Title  ICMJE Eszopiclone Co-Administered With Escitalopram for Insomnia in Elderly Adults With Major Depressive Disorder
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Insomnia
Intervention  ICMJE
  • Drug: Eszopiclone
    Eszopiclone 2mg daily at bedtime
    Other Name: Escitalopram 10mg or 20mg daily in the AM
  • Drug: Placebo
    Placebo daily at bedtime
    Other Name: Escitalopram 10mg or 20mg daily in the AM
  • Drug: Escitalopram
    Escitalopram 10mg or 20mg
Study Arms  ICMJE
  • Experimental: Eszopiclone
    Drug: Eszopiclone 2mg, Drug: Escitalopram 10mg or 20mg
    Interventions:
    • Drug: Eszopiclone
    • Drug: Escitalopram
  • Placebo Comparator: Placebo
    Drug: Placebo, Drug: Escitalopram 10mg or 20mg
    Interventions:
    • Drug: Placebo
    • Drug: Escitalopram
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 22, 2008)
60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2009
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years to 85 Years   (Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00813735
Other Study ID Numbers  ICMJE ESRCO66
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Lehigh Center for Clinical Research
Study Sponsor  ICMJE Lehigh Center for Clinical Research
Collaborators  ICMJE Sunovion
Investigators  ICMJE
Principal Investigator: Paul K Gross Lehigh Center for Clinical Research
PRS Account Lehigh Center for Clinical Research
Verification Date October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP