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Sponsors and Collaborators: |
Lehigh Center for Clinical Research Sepracor, Inc. |
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Information provided by: | Lehigh Center for Clinical Research |
ClinicalTrials.gov Identifier: | NCT00813735 |
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 |
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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 |
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 |
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Eszopiclone: Experimental
Drug: Eszopiclone 2mg, Drug: Escitalopram 10mg or 20mg
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Drug: Eszopiclone
Eszopiclone 2mg daily at bedtime
Drug: Escitalopram
Escitalopram 10mg or 20mg
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Placebo: Placebo Comparator
Drug: Placebo, Drug: Escitalopram 10mg or 20mg
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Drug: Placebo
Placebo daily at bedtime
Drug: Escitalopram
Escitalopram 10mg or 20mg
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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.
Ages Eligible for Study: | 65 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Paul K. Gross, MD | 610-820-0342 | pgross@lehighcenter.com |
Contact: Vince J. Gillen, BA | 610-820-0342 | vgillen@lehighcenter.com |
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 |
Principal Investigator: | Paul K Gross | Lehigh Center for Clinical Research |
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 |
Health Authority: | United States: Institutional Review Board |
Insomnia Major Depression Geriatric |
Sleep Initiation and Maintenance Disorders Depression Sleep Disorders Dyssomnias Depressive Disorder, Major Depressive Disorder Citalopram |
Serotonin Behavioral Symptoms Sleep Disorders, Intrinsic Mental Disorders Mood Disorders Dexetimide |
Parasympatholytics Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Cholinergic Antagonists Anti-Dyskinesia Agents Nervous System Diseases Physiological Effects of Drugs Psychotropic Drugs Antiparkinson Agents Cholinergic Agents |
Serotonin Uptake Inhibitors Pharmacologic Actions Muscarinic Antagonists Serotonin Agents Autonomic Agents Therapeutic Uses Peripheral Nervous System Agents Antidepressive Agents, Second-Generation Central Nervous System Agents Antidepressive Agents |