Ignite Creation Date:
2025-12-24 @ 2:16 PM
Ignite Modification Date:
2026-01-03 @ 11:00 AM
Study NCT ID:
NCT00322595
Status:
COMPLETED
Last Update Posted:
2008-12-22
First Post:
2006-05-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety Study of Seroquel SR in the Treatment of Generalized Anxiety Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Greece', 'Italy', 'Turkey (Türkiye)']}, 'conditionBrowseModule': {'meshes': [{'id': 'D000098647', 'term': 'Generalized Anxiety Disorder'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069348', 'term': 'Quetiapine Fumarate'}, {'id': 'D017374', 'term': 'Paroxetine'}], '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'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 800}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-12', 'completionDateStruct': {'date': '2007-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-12-18', 'studyFirstSubmitDate': '2006-05-05', 'studyFirstSubmitQcDate': '2006-05-05', 'lastUpdatePostDateStruct': {'date': '2008-12-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-05-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate the efficacy compared to placebo in the treatment of anxiety symptoms in patients with generalized anxiety disorder (GAD) at Day 57 (= end of treatment).'}], 'secondaryOutcomes': [{'measure': 'To evaluate efficacy by evaluating response rate.'}]}, 'conditionsModule': {'keywords': ['Anxiety', 'GAD'], 'conditions': ['Generalized Anxiety Disorder']}, 'referencesModule': {'references': [{'pmid': '24394383', 'type': 'DERIVED', 'citation': 'Montgomery SA, Locklear JC, Svedsater H, Eriksson H. Efficacy of once-daily extended release quetiapine fumarate in patients with different levels of severity of generalized anxiety disorder. Int Clin Psychopharmacol. 2014 Sep;29(5):252-62. doi: 10.1097/YIC.0000000000000026.'}, {'pmid': '22143997', 'type': 'DERIVED', 'citation': 'Stein DJ, Bandelow B, Merideth C, Olausson B, Szamosi J, Eriksson H. Efficacy and tolerability of extended release quetiapine fumarate (quetiapine XR) monotherapy in patients with generalised anxiety disorder: an analysis of pooled data from three 8-week placebo-controlled studies. Hum Psychopharmacol. 2011 Dec;26(8):614-28. doi: 10.1002/hup.1256. Epub 2011 Dec 6.'}, {'pmid': '19691907', 'type': 'DERIVED', 'citation': 'Bandelow B, Chouinard G, Bobes J, Ahokas A, Eggens I, Liu S, Eriksson H. Extended-release quetiapine fumarate (quetiapine XR): a once-daily monotherapy effective in generalized anxiety disorder. Data from a randomized, double-blind, placebo- and active-controlled study. Int J Neuropsychopharmacol. 2010 Apr;13(3):305-20. doi: 10.1017/S1461145709990423. Epub 2009 Aug 20.'}]}, 'descriptionModule': {'briefSummary': 'The primary purpose of this study is to evaluate the efficacy of (SEROQUEL SR™ ) quetiapine fumarate sustained-release (SR) compared to placebo in the treatment of anxiety symptoms in patients with generalized anxiety disorder (GAD).\n\nPLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female aged 18 to 65 years;\n* A diagnosis of generalized anxiety disorder;\n* Absence of current episode of major depression.\n\nExclusion Criteria:\n\n* The presence or history of schizophrenia and other psychotic disorders;\n* Hypertension;\n* A current diagnosis of cancer, unless in remission for at least 5 years'}, 'identificationModule': {'nctId': 'NCT00322595', 'acronym': 'SILVER', 'briefTitle': 'Efficacy and Safety Study of Seroquel SR in the Treatment of Generalized Anxiety Disorder', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'An International, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Active-Controlled Study of the Efficacy and Safety of Sustained-Release Quetiapine Fumarate (Seroquel SR™ ) in the Treatment of Generalized Anxiety Disorder (SILVER)', 'orgStudyIdInfo': {'id': 'D1448C00011'}, 'secondaryIdInfos': [{'id': '2005-005054-46'}, {'id': 'Silver'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Quetiapine fumarate', 'type': 'DRUG'}, {'name': 'Paroxetine', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'City Bell', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Research Site', 'geoPoint': {'lat': -34.8672, 'lon': -58.04755}}, {'city': 'Godoy Cruz', 'state': 'Mendoza Province', 'country': 'Argentina', 'facility': 'Research Site', 'geoPoint': {'lat': -32.92533, 'lon': -68.84428}}, {'city': 'Mendoza', 'state': 'Mendoza Province', 'country': 'Argentina', 'facility': 'Research Site', 'geoPoint': {'lat': -32.88946, 'lon': -68.84582}}, {'city': 'Rosario', 'state': 'Santa Fe Province', 'country': 'Argentina', 'facility': 'Research Site', 'geoPoint': {'lat': 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