Ignite Creation Date:
2025-12-24 @ 3:20 PM
Ignite Modification Date:
2026-03-03 @ 3:00 PM
Study NCT ID:
NCT00102492
Status:
COMPLETED
Last Update Posted:
2015-04-16
First Post:
2005-01-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study Of GW679769 In Major Depressive Disorder
Sponsor:
Organization:
Raw JSON
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'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-10'}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2006-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-14', 'studyFirstSubmitDate': '2005-01-29', 'studyFirstSubmitQcDate': '2005-01-28', 'lastUpdatePostDateStruct': {'date': '2015-04-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-01-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline on the 17-item Hamilton Depression Rating Scale (HAM-D) total score at week 8, Last Observation Carried Forward.'}], 'secondaryOutcomes': [{'measure': 'CGI, HAM-A, QUIDS, SDS, MOS-12 Sleep Module, LSEQ, Safety and Tolerability, PK/PD'}]}, 'conditionsModule': {'keywords': ['Major Depressive Disorder', 'Major Depression', 'Mood Disorders', 'Major Depressive Episode'], 'conditions': ['Depressive Disorder, Major', 'Major Depressive Disorder (MDD)']}, 'descriptionModule': {'briefSummary': 'This is a placebo-controlled, fixed dose study that will evaluate the efficacy and safety of GW679769 in subjects with major depressive disorder.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Subjects must have the ability to comprehend the key components of the consent form.\n* Subject must have met DSM-IV-TR (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision) criteria for current MDE (major depressive episode) for at least 8 weeks prior to the Screening Visit.\n* If female, subjects must be practicing an acceptable method of birth control.\n* Subjects must have rating scores as outlined.\n\nExclusion criteria:\n\n* Subjects whose symptoms of the MDE are better accounted for by another diagnosis.\n* Subjects with a history of schizophrenia, schizoaffective disorders or bipolar disorder.\n* Subjects have a positive urine test for illicit drug use and/or a history of substance abuse or alcohol dependence within the past 12 months.\n* Subjects with an unstable medical disorder.\n* If female, pregnant or lactating.\n* Subjects who have received ECT (electroconvulsive therapy) or TMS (transcranial magnetic stimulation) within the 6 months preceding screening or who have ever been homicidal.'}, 'identificationModule': {'nctId': 'NCT00102492', 'briefTitle': 'Study Of GW679769 In Major Depressive Disorder', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Fixed-Dose Study Evaluating the Efficacy and Safety of GW679769 in Subjects With Major Depressive Disorder.', 'orgStudyIdInfo': {'id': 'NKF100092'}}, 'armsInterventionsModule': {'interventions': [{'name': 'GW679769', 'type': 'DRUG'}]}, 'contactsLocationsModule': 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