Ignite Creation Date:
2025-12-24 @ 7:24 PM
Ignite Modification Date:
2025-12-29 @ 4:48 AM
Study NCT ID:
NCT01397903
Status:
COMPLETED
Last Update Posted:
2012-06-25
First Post:
2011-07-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Description of Treatment Management of Patients With Major Depressive Disorder and Inadequate Response
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003865', 'term': 'Depressive Disorder, Major'}], 'ancestors': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 545}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-06-22', 'studyFirstSubmitDate': '2011-07-18', 'studyFirstSubmitQcDate': '2011-07-19', 'lastUpdatePostDateStruct': {'date': '2012-06-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-07-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To assess the response of additional therapy by assessment of percentage of patients with CGI-I score ≤ 2', 'timeFrame': 'At week 4 after the commencement of add-on therapy'}], 'secondaryOutcomes': [{'measure': 'Number of consecutive treatments administered for the management of the current MDD episode until the commencement of adjunctive (add-on) medication.', 'timeFrame': 'At week 4 after the commencement of add-on therapy'}, {'measure': 'Percentage of patients (n, %) with MADRS score ≤ 10 at week 4 following the onset of adjunctive medication', 'timeFrame': 'At week 4 following the onset of add-on medication'}, {'measure': 'Percentage of patients (n,%) with a change (decrease) in MADRS score be ≥ 50%', 'timeFrame': 'At week 4 following the initiation of add-on drug therapy.'}]}, 'conditionsModule': {'keywords': ['antidepressant therapy, inadequate control, add-on therapy'], 'conditions': ['Major Depressive Disorder']}, 'descriptionModule': {'briefSummary': 'The purpose is to assess the response of add-on therapy, based on CGI-I scale, at 4 weeks, in patients with MDD who had an inadequate disease control with antidepressant medication.', 'detailedDescription': 'A cross-sectional observational study to describe treatment management of patients with Major Depressive Disorder (MDD) and inadequate response to antidepressants in Greece'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Psychiatric patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of MDD as per DSM-IV\n* Patients with an inadequate disease control during antidepressant therapy\n* Patients who already receive add-on therapy and have completed 4-5 weeks of treatment at the time of their enrolment in the study.\n\nExclusion Criteria:\n\n* Patients fulfilling criteria for diagnosis of any other psychiatric condition (except for MDD), as per DSM-IV Axis I,\n* Concomitant organic mental disorder or mental retardation Substance abuse or dependence (with the exception of nicotine dependence), as defined by DSM-IV criteria Participation in another study'}, 'identificationModule': {'nctId': 'NCT01397903', 'acronym': 'MADDRE', 'briefTitle': 'Description of Treatment Management of Patients With Major Depressive Disorder and Inadequate Response', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Cross-sectional Observational Study to Describe Treatment Management of Patients With Major Depressive Disorder (MDD) and Inadequate Response to Antidepressants in Greece', 'orgStudyIdInfo': {'id': 'NIS-NGR-XXX-2011/1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1', 'description': 'Inpatients and outpatients diagnosed with major depressive disorder as per the DSM-IV criteria who had poor disease control during antidepressant treatment and have completed 4 weeks of add-on drug therapy at enrolment in the study.\n\nThe percentage of patients with CGI-I score ≤ 2 at study Visit (4 weeks after the commencement of add-on treatment).'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Arta', 'state': 'Artas', 'country': 'Greece', 'facility': 'Research Site', 'geoPoint': {'lat': 39.16014, 'lon': 20.98561}}, {'city': 'Athens', 'state': 'Attica', 'country': 'Greece', 'facility': 'Research Site', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'city': 'Chaïdári', 'state': 'Attica', 'country': 'Greece', 'facility': 'Research Site', 'geoPoint': {'lat': 38.01135, 'lon': 23.66597}}, {'city': 'Dafni', 'state': 'Attica', 'country': 'Greece', 'facility': 'Research Site', 'geoPoint': {'lat': 37.95002, 'lon': 23.73437}}, {'city': 'Glyfada', 'state': 'Attica', 'country': 'Greece', 'facility': 'Research Site', 'geoPoint': {'lat': 37.86289, 'lon': 23.75802}}, {'city': 'Kifissia', 'state': 'Attica', 'country': 'Greece', 'facility': 'Research Site', 'geoPoint': {'lat': 38.07438, 'lon': 23.81106}}, {'city': 'Koropí', 'state': 'Attica', 'country': 'Greece', 'facility': 'Research Site', 'geoPoint': {'lat': 37.89886, 'lon': 23.87181}}, {'city': 'Marousi', 'state': 'Attica', 'country': 'Greece', 'facility': 'Research Site', 'geoPoint': {'lat': 38.05, 'lon': 23.8}}, {'city': 'Nea Makri', 'state': 'Attica', 'country': 'Greece', 'facility': 'Research Site', 'geoPoint': {'lat': 38.08733, 'lon': 23.97642}}, {'city': 'Peristeri', 'state': 'Attica', 'country': 'Greece', 'facility': 'Research Site', 'geoPoint': {'lat': 38.01539, 'lon': 23.69187}}, {'city': 'Petroúpolis', 'state': 'Attica', 'country': 'Greece', 'facility': 'Research Site', 'geoPoint': {'lat': 38.04187, 'lon': 23.68494}}, {'city': 'Rhodes', 'state': 'Dodekanese', 'country': 'Greece', 'facility': 'Research Site', 'geoPoint': {'lat': 36.43556, 'lon': 28.22199}}, {'city': 'Agrinio', 'state': 'Etoloacarnania', 'country': 'Greece', 'facility': 'Research Site', 'geoPoint': {'lat': 38.62139, 'lon': 21.40778}}, {'city': 'Lamia', 'state': 'Fhiotida', 'country': 'Greece', 'facility': 'Research Site', 'geoPoint': {'lat': 38.89947, 'lon': 22.4335}}, {'city': 'Heraklio', 'state': 'Heraklio', 'country': 'Greece', 'facility': 'Research Site'}, {'city': 'Ioannina', 'state': 'Ioanninon', 'country': 'Greece', 'facility': 'Research Site', 'geoPoint': {'lat': 39.66341, 'lon': 20.85187}}, {'city': 'Kalamata', 'state': 'Kalamata', 'country': 'Greece', 'facility': 'Research Site', 'geoPoint': {'lat': 37.03913, 'lon': 22.11265}}, {'city': 'Karditsa', 'state': 'Karditsa', 'country': 'Greece', 'facility': 'Research Site', 'geoPoint': {'lat': 39.36485, 'lon': 21.92191}}, {'city': 'Kavala', 'state': 'Kavala', 'country': 'Greece', 'facility': 'Research Site', 'geoPoint': {'lat': 40.93959, 'lon': 24.40687}}, {'city': 'Larissa', 'state': 'Larissa', 'country': 'Greece', 'facility': 'Research Site', 'geoPoint': {'lat': 39.62847, 'lon': 22.42112}}, {'city': 'Ag. Nikolaos', 'state': 'Lasithiou', 'country': 'Greece', 'facility': 'Research Site'}, {'city': 'Pátrai', 'state': 'Patras', 'country': 'Greece', 'facility': 'Research Site', 'geoPoint': {'lat': 38.2462, 'lon': 21.73508}}, {'city': 'Aigáleo', 'state': 'Piraeus', 'country': 'Greece', 'facility': 'Research Site', 'geoPoint': {'lat': 37.98333, 'lon': 23.68333}}, {'city': 'Serres', 'state': 'Serres', 'country': 'Greece', 'facility': 'Research Site', 'geoPoint': {'lat': 41.08499, 'lon': 23.54757}}, {'city': 'Thessaloniki', 'state': 'Thessaloniki', 'country': 'Greece', 'facility': 'Research Site', 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}, {'city': 'Trikala', 'state': 'Trikala', 'country': 'Greece', 'facility': 'Research Site', 'geoPoint': {'lat': 39.55493, 'lon': 21.76837}}, {'city': 'Thebes', 'state': 'Viotia', 'country': 'Greece', 'facility': 'Research Site', 'geoPoint': {'lat': 38.325, 'lon': 23.31889}}], 'overallOfficials': [{'name': 'Panagiotis Pontikis', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Marketing Company Medical and Regulatory Affairs Director, AstraZeneca S.A. Greece'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}