Ignite Creation Date:
2025-12-24 @ 5:37 PM
Ignite Modification Date:
2025-12-26 @ 10:47 AM
Study NCT ID:
NCT00733668
Status:
COMPLETED
Last Update Posted:
2009-03-25
First Post:
2008-08-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of SEROQUEL in Selective Serotonin Reuptake Inhibitors (SSRI)-Resistant Major Depressive Disorder
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069348', 'term': 'Quetiapine Fumarate'}], 'ancestors': [{'id': 'D003987', 'term': 'Dibenzothiazepines'}, {'id': 'D013841', 'term': 'Thiazepines'}, {'id': 'D013846', 'term': 'Thiepins'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-03', 'completionDateStruct': {'date': '2007-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-03-24', 'studyFirstSubmitDate': '2008-08-12', 'studyFirstSubmitQcDate': '2008-08-12', 'lastUpdatePostDateStruct': {'date': '2009-03-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-08-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Montgomery-Asberg Depression Scale (MADRS) score', 'timeFrame': 'Visit 1 - > 5'}], 'secondaryOutcomes': [{'measure': 'The Brief psychiatric Rating Scale (BPRS) scoreThe Clinical Global impression (CGI) scorePatient reported outcomes (PROs)', 'timeFrame': 'Visit 1 - > 5 (1 week between each visit)'}, {'measure': 'Sheehan Disability Scale (SDS) score', 'timeFrame': 'Visit 1 - > 5 (1 week between each visit)'}, {'measure': 'The Symptom Checklist 90 Revisred (SCL-90-R) score', 'timeFrame': 'Visit 1 - > 5 (1 week between each visit)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['considered', 'entry', 'into', 'the study', 'SSRI', 'Seroquel', 'Quetiapine', 'fumarate', 'antipsychotic'], 'conditions': ['Major Depressive Disorder']}, 'descriptionModule': {'briefSummary': 'An open-label, non-comparative, multi-centre, phase II prospective trial to assess the efficacy of Quetiapine fumarate augmentation of selective serotonin reuptake inhibitors (SSRIs) in SSRI-resistant major depressive disorder.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Inform consent\n* Male and female, age between 18 and 65 years.\n* Naïve to any atypical antipsychotic\n* A diagnosis of major depressive disorder\n\nExclusion Criteria:\n\n* No use of fluvoxamine\n* Patients with a history of bipolar I or II disorder\n* Diagnosis of psychotic major depression disorder'}, 'identificationModule': {'nctId': 'NCT00733668', 'acronym': 'UNIQUE', 'briefTitle': 'Efficacy of SEROQUEL in Selective Serotonin Reuptake Inhibitors (SSRI)-Resistant Major Depressive Disorder', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'An Open-Label, Non-Comparative, Multi-Centre, Phase II Prospective Trial to Assess the Efficacy of Quetiapine Fumarate Augmentation of Selective Serotonin Reuptake Inhibitors (SSRIs) in SSRI-Resistant Major Depressive Disorder.', 'orgStudyIdInfo': {'id': 'D1449C00009'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Quetiapine fumarate (Seroquel)', 'type': 'DRUG', 'otherNames': ['Seroquel'], 'description': '300 mg, PO, 100 mg morning, 200 mg evening, 4 weeks'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bruges', 'country': 'Belgium', 'facility': 'Research Site', 'geoPoint': {'lat': 51.20892, 'lon': 3.22424}}, {'city': 'Leuven', 'country': 'Belgium', 'facility': 'Research Site', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'city': 'Liège', 'country': 'Belgium', 'facility': 'Research Site', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}, {'city': 'Sint-Truiden', 'country': 'Belgium', 'facility': 'Research Site', 'geoPoint': {'lat': 50.81679, 'lon': 5.18647}}], 'overallOfficials': [{'name': 'Pr. Demyttenaere', 'role': 'STUDY_DIRECTOR', 'affiliation': 'KUL'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'An Matthys, MD, Therapeutic Area Leader CNS', 'oldOrganization': 'AstraZeneca Pharmaceuticals'}}}}