Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2025-12-30 @ 1:34 PM
Study NCT ID:
NCT00351169
Status:
COMPLETED
Last Update Posted:
2008-12-22
First Post:
2006-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Seroquel SR in Combination With an Antidepressant in Treatment of 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': 'D000089983', 'term': 'Escitalopram'}], 'ancestors': [{'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'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 450}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-12', 'completionDateStruct': {'date': '2007-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-12-18', 'studyFirstSubmitDate': '2006-07-11', 'studyFirstSubmitQcDate': '2006-07-11', 'lastUpdatePostDateStruct': {'date': '2008-12-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-07-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate the efficacy of quetiapine SR compared with placebo in the treatment of patients with major depressive disorder (MDD) as assessed by change from randomisation to week 8 score in the MADRS total score.'}], 'secondaryOutcomes': [{'measure': 'If quetiapine SR improves health-related quality of life of patients with MDD, compared to placebo'}]}, 'conditionsModule': {'keywords': ['Major Depressive Disorder', 'MDD'], 'conditions': ['Major Depressive Disorder']}, 'referencesModule': {'references': [{'pmid': '26474010', 'type': 'DERIVED', 'citation': 'McIntyre RS, Gorwood P, Thase ME, Liss C, Desai D, Chen J, Bauer M. Early Symptom Improvement as a Predictor of Response to Extended Release Quetiapine in Major Depressive Disorder. J Clin Psychopharmacol. 2015 Dec;35(6):706-10. doi: 10.1097/JCP.0000000000000416.'}, {'pmid': '24816198', 'type': 'DERIVED', 'citation': 'Weisler R, Montgomery SA, Earley WR, Szamosi J, Eriksson H. Extended release quetiapine fumarate in patients with major depressive disorder: suicidality data from acute and maintenance studies. J Clin Psychiatry. 2014 May;75(5):520-7. doi: 10.4088/JCP.13m08624.'}, {'pmid': '24175720', 'type': 'DERIVED', 'citation': 'Weisler R, McIntyre RS. The role of extended-release quetiapine fumarate monotherapy in the treatment of patients with major depressive disorder. Expert Rev Neurother. 2013 Nov;13(11):1161-82. doi: 10.1586/14737175.2013.846520.'}, {'pmid': '24067192', 'type': 'DERIVED', 'citation': 'Clayton AH, Locklear JC, Svedsater H, McIntyre RS. Sexual functioning in patients with major depressive disorder in randomized placebo-controlled studies of extended release quetiapine fumarate. CNS Spectr. 2014 Apr;19(2):182-96. doi: 10.1017/S1092852913000631. Epub 2013 Sep 25.'}, {'pmid': '23673347', 'type': 'DERIVED', 'citation': 'Trivedi MH, Bandelow B, Demyttenaere K, Papakostas GI, Szamosi J, Earley W, Eriksson H. Evaluation of the effects of extended release quetiapine fumarate monotherapy on sleep disturbance in patients with major depressive disorder: a pooled analysis of four randomized acute studies. Int J Neuropsychopharmacol. 2013 Sep;16(8):1733-44. doi: 10.1017/S146114571300028X. Epub 2013 May 14.'}, {'pmid': '23485955', 'type': 'DERIVED', 'citation': 'Thase ME, Montgomery S, Papakostas GI, Bauer M, Trivedi MH, Svedsater H, Locklear JC, Gustafsson U, Datto C, Eriksson H. Quetiapine XR monotherapy in major depressive disorder: a pooled analysis to assess the influence of baseline severity on efficacy. Int Clin Psychopharmacol. 2013 May;28(3):113-20. doi: 10.1097/YIC.0b013e32835fb971.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the efficacy and safety of quetiapine fumarate sustained release (Seroquel SR) in the treatment of Major Depressive Disorder.\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 documented diagnosis of major depressive disorder\n\nExclusion Criteria:\n\n* Patients with a DSM IV Axis I disorder other than MDD within 6 months of enrolment\n* Patients with a diagnosis of DSM IV Axis II disorder which has a major impact on the patient's current psychiatric status\n* Patients whose current episode of depression exceeds 12 months or is less than 4 weeks prior to enrolment"}, 'identificationModule': {'nctId': 'NCT00351169', 'acronym': 'AMBER', 'briefTitle': 'Efficacy of Seroquel SR in Combination With an Antidepressant in Treatment of Major Depressive Disorder', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Multi-Centre, Double-Blind, Randomised, Parallel Group, Placebo- Controlled and Active Controlled Phase III Study of the Efficacy and Safety of Quetiapine Fumarate Sustained Release (Seroquel SRTM) as Mono- Therapy in the Treatment of Adult Patients With Major Depressive Disorder', 'orgStudyIdInfo': {'id': 'D1448C00004'}, 'secondaryIdInfos': [{'id': 'AMBER'}, {'id': 'EUDRACT No: 2005-005052-40'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Quetiapine SR', 'type': 'DRUG'}, {'name': 'Escitalopram', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Research Site', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'city': 'Kelowna', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Research Site', 'geoPoint': {'lat': 49.88307, 'lon': -119.48568}}, {'city': 'Penticton', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Research Site', 'geoPoint': {'lat': 49.48062, 'lon': 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'Aguascalientes', 'country': 'Mexico', 'facility': 'Research Site', 'geoPoint': {'lat': 21.88262, 'lon': -102.2843}}, {'city': 'Distrito Federal', 'country': 'Mexico', 'facility': 'Research Site', 'geoPoint': {'lat': 16.59, 'lon': -93.02694}}, {'city': 'Guadalajara', 'country': 'Mexico', 'facility': 'Research Site', 'geoPoint': {'lat': 20.67738, 'lon': -103.34749}}, {'city': 'Cebu City', 'country': 'Philippines', 'facility': 'Research Site', 'geoPoint': {'lat': 10.31672, 'lon': 123.89071}}, {'city': 'Davao City', 'country': 'Philippines', 'facility': 'Research Site', 'geoPoint': {'lat': 7.07306, 'lon': 125.61278}}, {'city': 'Mandaluyong', 'country': 'Philippines', 'facility': 'Research Site', 'geoPoint': {'lat': 14.5832, 'lon': 121.0409}}, {'city': 'Manila', 'country': 'Philippines', 'facility': 'Research Site', 'geoPoint': {'lat': 14.6042, 'lon': 120.9822}}, {'city': 'Benoni', 'country': 'South Africa', 'facility': 'Research Site', 'geoPoint': {'lat': -26.18848, 'lon': 28.32078}}, {'city': 'Cape Town', 'country': 'South Africa', 'facility': 'Research Site', 'geoPoint': {'lat': -33.92584, 'lon': 18.42322}}, {'city': 'Durban', 'country': 'South Africa', 'facility': 'Research Site', 'geoPoint': {'lat': -29.8579, 'lon': 31.0292}}, {'city': 'Johannesburg', 'country': 'South Africa', 'facility': 'Research Site', 'geoPoint': {'lat': -26.20227, 'lon': 28.04363}}, {'city': 'Krugersdorp', 'country': 'South Africa', 'facility': 'Research Site', 'geoPoint': {'lat': -26.08577, 'lon': 27.77515}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Research Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Langreo', 'country': 'Spain', 'facility': 'Research Site', 'geoPoint': {'lat': 43.29568, 'lon': -5.68416}}, {'city': 'Vigo', 'country': 'Spain', 'facility': 'Research Site', 'geoPoint': {'lat': 42.23282, 'lon': -8.72264}}, {'city': 'Zamora', 'country': 'Spain', 'facility': 'Research Site', 'geoPoint': {'lat': 41.50633, 'lon': -5.74456}}], 'overallOfficials': [{'name': 'Willie Earley, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}}}}