Ignite Creation Date:
2025-12-24 @ 10:34 PM
Ignite Modification Date:
2026-01-01 @ 9:31 PM
Study NCT ID:
NCT00813735
Status:
COMPLETED
Last Update Posted:
2012-10-03
First Post:
2008-12-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Eszopiclone Co-Administered With Escitalopram for Insomnia in Elderly Adults With Major Depressive Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'releaseDate': '2014-09-08', 'unreleaseDateUnknown': True}, {'resetDate': '2014-09-12', 'releaseDate': '2014-09-09'}], 'estimatedResultsFirstSubmitDate': '2014-09-08'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}, {'id': 'D003865', 'term': 'Depressive Disorder, Major'}], 'ancestors': [{'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069582', 'term': 'Eszopiclone'}, {'id': 'D000089983', 'term': 'Escitalopram'}], 'ancestors': [{'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011719', 'term': 'Pyrazines'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D011437', 'term': 'Propylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009570', 'term': 'Nitriles'}, {'id': 'D001572', 'term': 'Benzofurans'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'completionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-10-02', 'studyFirstSubmitDate': '2008-12-22', 'studyFirstSubmitQcDate': '2008-12-22', 'lastUpdatePostDateStruct': {'date': '2012-10-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-12-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in total sleep time from baseline to final visit', 'timeFrame': 'from baseline to final visit'}], 'secondaryOutcomes': [{'measure': 'change in sleep latency from baseline to final visit', 'timeFrame': 'from baseline to final visit'}, {'measure': 'Change in HAMD from baseline to final visit', 'timeFrame': 'from baseline to final visit'}, {'measure': 'Change in ISI from baseline to final visit', 'timeFrame': 'baseline to final visit'}, {'measure': 'Change in CGI-S, CGI-I from baseline to final visit', 'timeFrame': 'baseline to final visit'}, {'measure': 'labs (CBC,urinalysis,TSH,Chemprofile,drugscreen),height', 'timeFrame': 'visit 1'}, {'measure': "vitals: BP,pulse,temperature,weight,assess AE's/SAE's", 'timeFrame': 'every visit'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Insomnia', 'Major Depression', 'Geriatric'], 'conditions': ['Insomnia']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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\n\nExclusion Criteria:\n\n* 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'}, 'identificationModule': {'nctId': 'NCT00813735', 'briefTitle': 'Eszopiclone Co-Administered With Escitalopram for Insomnia in Elderly Adults With Major Depressive Disorder', 'organization': {'class': 'OTHER', 'fullName': 'Lehigh Center for Clinical Research'}, 'officialTitle': 'Eszopiclone Co-Administered With Escitalopram for Insomnia in Elderly Adults With Major Depressive Disorder', 'orgStudyIdInfo': {'id': 'ESRCO66'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Eszopiclone', 'description': 'Drug: Eszopiclone 2mg, Drug: Escitalopram 10mg or 20mg', 'interventionNames': ['Drug: Eszopiclone', 'Drug: Escitalopram']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Drug: Placebo, Drug: Escitalopram 10mg or 20mg', 'interventionNames': ['Drug: Placebo', 'Drug: Escitalopram']}], 'interventions': [{'name': 'Eszopiclone', 'type': 'DRUG', 'otherNames': ['Escitalopram 10mg or 20mg daily in the AM'], 'description': 'Eszopiclone 2mg daily at bedtime', 'armGroupLabels': ['Eszopiclone']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Escitalopram 10mg or 20mg daily in the AM'], 'description': 'Placebo daily at bedtime', 'armGroupLabels': ['Placebo']}, {'name': 'Escitalopram', 'type': 'DRUG', 'description': 'Escitalopram 10mg or 20mg', 'armGroupLabels': ['Eszopiclone', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '18104', 'city': 'Allentown', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Lehigh Center for Clinical Research', 'geoPoint': {'lat': 40.60843, 'lon': -75.49018}}], 'overallOfficials': [{'name': 'Paul K Gross', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lehigh Center for Clinical Research'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lehigh Center for Clinical Research', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sumitomo Pharma America, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2014-09-08', 'type': 'RELEASE'}, {'type': 'UNRELEASE', 'dateUnknown': True}, {'date': '2014-09-09', 'type': 'RELEASE'}, {'date': '2014-09-12', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Lehigh Center for Clinical Research'}}}}