Ignite Creation Date:
2025-12-25 @ 2:27 AM
Ignite Modification Date:
2025-12-27 @ 4:57 AM
Study NCT ID:
NCT00292734
Status:
COMPLETED
Last Update Posted:
2007-12-06
First Post:
2006-02-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
STILDEP: Zolpidem in Depressive and Dysthimic Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}, {'id': 'D003863', 'term': 'Depression'}], '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': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077334', 'term': 'Zolpidem'}], 'ancestors': [{'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-12', 'completionDateStruct': {'date': '2006-06'}, 'lastUpdateSubmitDate': '2007-12-04', 'studyFirstSubmitDate': '2006-02-15', 'studyFirstSubmitQcDate': '2006-02-15', 'lastUpdatePostDateStruct': {'date': '2007-12-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-02-16', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To show that the combination of Stilnox+ antidepressant therapy is more effective in the treatment of the secondary insomnia of depressive and dysthimic patients than antidepressant therapy alone in the acute phase of the disease'}]}, 'conditionsModule': {'conditions': ['Sleep Initiation and Maintenance Disorders', 'Depression']}, 'descriptionModule': {'briefSummary': 'Primary objective: To show that the combination of Zolpidem + antidepressant therapy is more effective in the treatment of the secondary insomnia of depressive and dysthimic patients than antidepressant therapy alone in the acute phase of the disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Depressive and dysthimic patients in acute phase of mild to moderate severity\n* Depressive and dysthimic patients suffering from secondary insomnia (DSM IV) recent antidepressant therapy (less than 1 week)\n\nExclusion Criteria:\n\n* Regularly use of sleeping pills in the last 2-3 month\n* Use of any sleeping pils in the last week\n* Insufficient hepatic\n* Myasthenia gravis\n* Proven hypersensivity to Zolpidem\n* Evidence of clinically relevant nervous system disorders (other neurologic/psychiatric diseases associated with depression)\n* History of evidence of alcohol or drug abuse\n* Evidence of clinically relevant cardiovascular, haematologic, hepatic, gastrointestinal, renal, pulmonary or endocrinologic diseases\n* Abnormal snore\n* Work an alternating shift\n* Suffering from periodic leg movement disorder and sleep apnea'}, 'identificationModule': {'nctId': 'NCT00292734', 'briefTitle': 'STILDEP: Zolpidem in Depressive and Dysthimic Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'Additive Beneficial Effect of Zolpidem Onto the Antidepressant Therapy in Depressive and Dysthimic Patients in the Acute Phase of the Disease', 'orgStudyIdInfo': {'id': 'L_9259'}, 'secondaryIdInfos': [{'id': 'EudraCT # : 2004-001967-24'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Zolpidem', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Budapest', 'country': 'Hungary', 'facility': 'Sanofi-Aventis', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}], 'overallOfficials': [{'name': 'László Erős, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'sanofi-aventis Hungary'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}}}}