Eszopiclone Co-Administered With Escitalopram for Insomnia in Elderly Adults With Major Depressive Disorder
This study has been completed.
Sponsor:
Lehigh Center for Clinical Research
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
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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
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:
|
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 May 22, 2013