Ignite Creation Date:
2025-12-24 @ 11:59 AM
Ignite Modification Date:
2026-01-11 @ 10:55 PM
Study NCT ID:
NCT00803361
Status:
COMPLETED
Last Update Posted:
2010-12-17
First Post:
2008-12-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Duloxetine for the Treatment of Generalized Anxiety Disorder
Sponsor:
Organization:
Raw JSON
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'Duloxetine', 'description': '60 to 120 mg, capsules, oral, once a day for 15 weeks', 'otherNumAtRisk': 108, 'otherNumAffected': 67, 'seriousNumAtRisk': 108, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'placebo capsules, oral, once a day for 15 weeks', 'otherNumAtRisk': 102, 'otherNumAffected': 45, 'seriousNumAtRisk': 102, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 102, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 102, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 102, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 102, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 32, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 102, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 102, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 102, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 102, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 16, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 102, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 102, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 14, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 102, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 102, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 102, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}], 'seriousEvents': [{'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) Anxiety Subscale Score at Endpoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Duloxetine', 'description': '60 to 120 mg, capsules, oral, once a day for 15 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'placebo capsules, oral, once a day for 15 weeks'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '12.76', 'spread': '2.89', 'groupId': 'OG000'}, {'value': '13.56', 'spread': '2.96', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline', 'categories': [{'measurements': [{'value': '-6.38', 'spread': '4.44', 'groupId': 'OG000'}, {'value': '-5.29', 'spread': '4.78', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.006', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.62', 'ciLowerLimit': '-2.76', 'ciUpperLimit': '-0.48', 'pValueComment': 'p-value is for Change from Baseline.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Change = Treatment + Pooled Investigator + Baseline', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 15', 'description': "A 14-item questionnaire with 2 subscales: anxiety and depression. Each item is rated on a 4-point scale, giving maximum scores of 21 for anxiety and depression. Scores of 11 or more on either subscale are considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7, 'normal.'", 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with a baseline and at least one post-baseline result within each treatment group.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Hamilton Anxiety (HAMA) Rating Scale Total Score at Endpoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Duloxetine', 'description': '60 to 120 mg, capsules, oral, once a day for 15 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'placebo capsules, oral, once a day for 15 weeks'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '24.50', 'spread': '5.81', 'groupId': 'OG000'}, {'value': '24.24', 'spread': '5.16', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline', 'categories': [{'measurements': [{'value': '-14.42', 'spread': '9.05', 'groupId': 'OG000'}, {'value': '-11.62', 'spread': '8.31', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.024', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.56', 'ciLowerLimit': '-4.78', 'ciUpperLimit': '-0.34', 'pValueComment': 'p-value is for Change from Baseline', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Change = Treatment + Pooled Investigator + Baseline', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 15', 'description': 'The HAMA scale measures anxiety symptoms accompanying Major Depressive Disorder (MDD). Each item of the 14-item HAMA was scored from 0 (not present) to 4 (very severe), with a resulting maximum total score of 56.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with a baseline and at least one post-baseline result within each treatment group.'}, {'type': 'SECONDARY', 'title': 'Mean Clinical Global Impressions (CGI) Improvement Score at Endpoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Duloxetine', 'description': '60 to 120 mg, capsules, oral, once a day for 15 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'placebo capsules, oral, once a day for 15 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '2.08', 'spread': '0.97', 'groupId': 'OG000'}, {'value': '2.54', 'spread': '1.20', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.004', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.44', 'ciLowerLimit': '-0.74', 'ciUpperLimit': '-0.15', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Week 15', 'description': "Measures clinician's perception of patient improvement at the time of assessment compared with the start of treatment. Scores range from 1 (very much better) to 7 (very much worse).", 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with at least one post-baseline result within each treatment group.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Brief Pain Inventory (BPI) - Short Form Severity (BPI-S) and Interference (BPI-I) Scores at Endpoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Duloxetine', 'description': '60 to 120 mg, capsules, oral, once a day for 15 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'placebo capsules, oral, once a day for 15 weeks'}], 'classes': [{'title': 'Severity of Worst Pain Baseline', 'categories': [{'measurements': [{'value': '3.39', 'spread': '2.84', 'groupId': 'OG000'}, {'value': '4.22', 'spread': '3.03', 'groupId': 'OG001'}]}]}, {'title': 'Severity of Worst Pain Change', 'categories': [{'measurements': [{'value': '-1.78', 'spread': '2.44', 'groupId': 'OG000'}, {'value': '-1.88', 'spread': '2.78', 'groupId': 'OG001'}]}]}, {'title': 'Severity of Least Pain Baseline', 'categories': [{'measurements': [{'value': '1.17', 'spread': '1.51', 'groupId': 'OG000'}, {'value': '1.51', 'spread': '1.81', 'groupId': 'OG001'}]}]}, {'title': 'Severity of Least Pain Change', 'categories': [{'measurements': [{'value': '-0.67', 'spread': '1.32', 'groupId': 'OG000'}, {'value': '-0.45', 'spread': '1.70', 'groupId': 'OG001'}]}]}, {'title': 'Severity of Average Pain Baseline', 'categories': [{'measurements': [{'value': '2.36', 'spread': '2.26', 'groupId': 'OG000'}, {'value': '2.77', 'spread': '2.20', 'groupId': 'OG001'}]}]}, {'title': 'Severity of Average Pain Change', 'categories': [{'measurements': [{'value': '-1.25', 'spread': '1.94', 'groupId': 'OG000'}, {'value': '-0.97', 'spread': '2.06', 'groupId': 'OG001'}]}]}, {'title': 'Severity of Pain Right Now Baseline', 'categories': [{'measurements': [{'value': '2.21', 'spread': '2.58', 'groupId': 'OG000'}, {'value': '2.30', 'spread': '2.68', 'groupId': 'OG001'}]}]}, {'title': 'Severity of Pain Right Now Change', 'categories': [{'measurements': [{'value': '-1.41', 'spread': '2.29', 'groupId': 'OG000'}, {'value': '-0.77', 'spread': '2.54', 'groupId': 'OG001'}]}]}, {'title': 'Interference of Pain, General Activity, Baseline', 'categories': [{'measurements': [{'value': '2.60', 'spread': '2.81', 'groupId': 'OG000'}, {'value': '2.66', 'spread': '2.69', 'groupId': 'OG001'}]}]}, {'title': 'Interference of Pain, General Activity, Change', 'categories': [{'measurements': [{'value': '-1.43', 'spread': '2.40', 'groupId': 'OG000'}, {'value': '-1.06', 'spread': '2.43', 'groupId': 'OG001'}]}]}, {'title': 'Interference of Pain, Mood, Baseline', 'categories': [{'measurements': [{'value': '2.97', 'spread': '3.04', 'groupId': 'OG000'}, {'value': '3.40', 'spread': '2.87', 'groupId': 'OG001'}]}]}, {'title': 'Interference of Pain, Mood, Change', 'categories': [{'measurements': [{'value': '-1.49', 'spread': '2.71', 'groupId': 'OG000'}, {'value': '-1.44', 'spread': '2.57', 'groupId': 'OG001'}]}]}, {'title': 'Interference of Pain,Walking Ability, Baseline', 'categories': [{'measurements': [{'value': '1.31', 'spread': '2.07', 'groupId': 'OG000'}, {'value': '1.56', 'spread': '2.16', 'groupId': 'OG001'}]}]}, {'title': 'Interference of Pain,Walking Ability, Change', 'categories': [{'measurements': [{'value': '-0.63', 'spread': '2.01', 'groupId': 'OG000'}, {'value': '-0.47', 'spread': '1.95', 'groupId': 'OG001'}]}]}, {'title': 'Int. of Pain, Normal Work, Baseline', 'categories': [{'measurements': [{'value': '2.53', 'spread': '2.77', 'groupId': 'OG000'}, {'value': '2.44', 'spread': '2.67', 'groupId': 'OG001'}]}]}, {'title': 'Int. of Pain, Normal Work, Change', 'categories': [{'measurements': [{'value': '-1.25', 'spread': '2.54', 'groupId': 'OG000'}, {'value': '-0.96', 'spread': '2.43', 'groupId': 'OG001'}]}]}, {'title': 'Int. of Pain, Relations with Others, Baseline', 'categories': [{'measurements': [{'value': '2.01', 'spread': '2.59', 'groupId': 'OG000'}, {'value': '2.01', 'spread': '2.52', 'groupId': 'OG001'}]}]}, {'title': 'Int. of Pain, Relations with Others, Change', 'categories': [{'measurements': [{'value': '-1.07', 'spread': '2.22', 'groupId': 'OG000'}, {'value': '-0.88', 'spread': '2.07', 'groupId': 'OG001'}]}]}, {'title': 'Interference of Pain, Sleep, Baseline', 'categories': [{'measurements': [{'value': '2.55', 'spread': '3.09', 'groupId': 'OG000'}, {'value': '3.23', 'spread': '3.15', 'groupId': 'OG001'}]}]}, {'title': 'Interference of Pain, Sleep, Change', 'categories': [{'measurements': [{'value': '-1.16', 'spread': '2.56', 'groupId': 'OG000'}, {'value': '-1.45', 'spread': '2.68', 'groupId': 'OG001'}]}]}, {'title': 'Interference of Pain, Enjoyment of Life, Baseline', 'categories': [{'measurements': [{'value': '2.51', 'spread': '2.80', 'groupId': 'OG000'}, {'value': '2.62', 'spread': '2.37', 'groupId': 'OG001'}]}]}, {'title': 'Interference of Pain, Enjoyment of Life, Change', 'categories': [{'measurements': [{'value': '-1.27', 'spread': '2.73', 'groupId': 'OG000'}, {'value': '-0.99', 'spread': '2.20', 'groupId': 'OG001'}]}]}, {'title': 'Mean Interference Score, Baseline', 'categories': [{'measurements': [{'value': '2.36', 'spread': '2.46', 'groupId': 'OG000'}, {'value': '2.56', 'spread': '2.25', 'groupId': 'OG001'}]}]}, {'title': 'Mean Interference Score, Change', 'categories': [{'measurements': [{'value': '-1.18', 'spread': '2.13', 'groupId': 'OG000'}, {'value': '-1.04', 'spread': '1.84', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.125', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.41', 'ciLowerLimit': '-0.93', 'ciUpperLimit': '0.11', 'pValueComment': 'p-value is for Severity of Worst Pain Change.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Change = Treatment + Pooled Investigator + Baseline', 'testedNonInferiority': False}, {'pValue': '0.014', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.42', 'ciLowerLimit': '-0.75', 'ciUpperLimit': '-0.09', 'pValueComment': 'p-value is for Severity of Least Pain Change.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Change = Treatment + Pooled Investigator + Baseline', 'testedNonInferiority': False}, {'pValue': '0.012', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.52', 'ciLowerLimit': '-0.93', 'ciUpperLimit': '-0.11', 'pValueComment': 'p-value is for Severity of Average Pain Change.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Change = Treatment + Pooled Investigator + Baseline', 'testedNonInferiority': False}, {'pValue': '0.002', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.69', 'ciLowerLimit': '-1.14', 'ciUpperLimit': '-0.25', 'pValueComment': 'p-value is for Severity of Pain Right Now Change.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Change = Treatment + Pooled Investigator + Baseline', 'testedNonInferiority': False}, {'pValue': '0.101', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.40', 'ciLowerLimit': '-0.87', 'ciUpperLimit': '0.08', 'pValueComment': 'p-value is for Interference of Pain, General Activity, Change.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Change = Treatment + Pooled Investigator + Baseline', 'testedNonInferiority': False}, {'pValue': '0.252', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.31', 'ciLowerLimit': '-0.83', 'ciUpperLimit': '0.22', 'pValueComment': 'p-value is for Interference of Pain, Mood, Change.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Change = Treatment + Pooled Investigator + Baseline', 'testedNonInferiority': False}, {'pValue': '0.149', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.30', 'ciLowerLimit': '-0.72', 'ciUpperLimit': '0.11', 'pValueComment': 'p-value is for Interference of Pain,Walking Ability, Change.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 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'Change = Treatment + Pooled Investigator + Baseline', 'testedNonInferiority': False}, {'pValue': '0.731', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.09', 'ciLowerLimit': '-0.63', 'ciUpperLimit': '0.44', 'pValueComment': 'p-value is for Interference of Pain, Sleep, Change.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Change = Treatment + Pooled Investigator + Baseline', 'testedNonInferiority': False}, {'pValue': '0.186', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.34', 'ciLowerLimit': '-0.85', 'ciUpperLimit': '0.17', 'pValueComment': 'p-value is for Interference of Pain, Enjoyment of Life, Change.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Change = Treatment + Pooled 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'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'China', 'categories': [{'measurements': [{'value': '108', 'groupId': 'BG000'}, {'value': '102', 'groupId': 'BG001'}, {'value': '210', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 210}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-11', 'completionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-11-19', 'studyFirstSubmitDate': '2008-12-03', 'resultsFirstSubmitDate': '2010-11-19', 'studyFirstSubmitQcDate': '2008-12-03', 'lastUpdatePostDateStruct': {'date': '2010-12-17', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-11-19', 'studyFirstPostDateStruct': {'date': '2008-12-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-12-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) Anxiety 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Each item is rated on a 4-point scale, giving maximum scores of 21 for anxiety and depression. Scores of 11 or more on either subscale are considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7, 'normal.'"}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in the Hamilton Anxiety (HAMA) Rating Scale Total Score at Endpoint', 'timeFrame': 'Baseline, Week 15', 'description': 'The HAMA scale measures anxiety symptoms accompanying Major Depressive Disorder (MDD). Each item of the 14-item HAMA was scored from 0 (not present) to 4 (very severe), with a resulting maximum total score of 56.'}, {'measure': 'Mean Clinical Global Impressions (CGI) Improvement Score at Endpoint', 'timeFrame': 'Week 15', 'description': "Measures clinician's perception of patient improvement at the time of assessment compared with the start of treatment. 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Interference scores: 0 (does not interfere) to 10 (completely interferes) on each question assessing interference of pain in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life.'}, {'measure': 'Change From Baseline in Sheehan Disability Scale (SDS) at Endpoint, Global Functioning Scores', 'timeFrame': 'Baseline, Week 15', 'description': "The SDS is completed by the patient and is used to assess the effect of the patient's symptoms on their work/social/family life. Total scores range from 0 to 30 with higher values indicating greater disruption in the patient's work/social/family life. Individual item scores range from 0-10, with higher numbers indicating greater disruption. Item 1 is for work/schoolwork, Item 2 is for social life/leisure activities, Item 3 is for family life/home responsibilities."}, {'measure': 'Change From Baseline in Visual Analogue Scale (VAS) for Pain at Endpoint', 'timeFrame': 'Baseline, Week 15', 'description': 'VAS for pain consists of 6 questions that assess overall pain, headache, back pain, shoulder pain, pain interference with daily activities, and pain while awake. Participant rates pain on a 100 millimeter (mm) line between two anchors (0= no pain and 100=very severe pain).'}, {'measure': 'Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) Depression Subscale Score at Endpoint', 'timeFrame': 'Baseline, Week 15', 'description': "A 14-item questionnaire with 2 subscales: anxiety and depression. Each item is rated on a 4-point scale, giving maximum scores of 21 for anxiety and depression. Scores of 11 or more on either subscale are considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7, 'normal.'"}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['anxiety'], 'conditions': ['Generalized Anxiety Disorder']}, 'referencesModule': {'references': [{'pmid': '22088518', 'type': 'DERIVED', 'citation': 'Wu WY, Wang G, Ball SG, Desaiah D, Ang QQ. Duloxetine versus placebo in the treatment of patients with generalized anxiety disorder in China. Chin Med J (Engl). 2011 Oct;124(20):3260-8.'}]}, 'descriptionModule': {'briefSummary': 'This is a 15 week study comparing how well duloxetine and placebo treatments improve generalized anxiety disorder'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Psychiatric Diagnosis of generalized anxiety disorder (GAD)\n* Outpatients\n* Meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) diagnosis for GAD\n* Clinical Global Impression (CGI) of Severity Score of at least moderate\n* Sheehan Disability Scale (SDS) Global Functioning Impairment Score \\>= 12\n\nExclusion Criteria:\n\n* Pregnancy or breast feeding\n* Serious medical illness\n* Other primary psychiatric diagnoses, such as major depressive disorder or substance abuse disorder within the past 6 months\n* panic disorder, post-traumatic stress disorder (PTSD), or eating disorder in the last year\n* lifetime history of bipolar or psychosis\n* Any unstable serious medical condition for which duloxetine would not be allowed\n* Any use of medications that are not allowed'}, 'identificationModule': {'nctId': 'NCT00803361', 'briefTitle': 'Duloxetine for the Treatment of Generalized Anxiety Disorder', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'Duloxetine Versus Placebo in the Treatment of Patients With Generalized Anxiety Disorder in China', 'orgStudyIdInfo': {'id': '11517'}, 'secondaryIdInfos': [{'id': 'F1J-MC-HMFJ', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Duloxetine', 'interventionNames': ['Drug: Duloxetine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Duloxetine', 'type': 'DRUG', 'otherNames': ['Cymbalta', 'LY248686'], 'description': '60 to 120 mg, capsules, oral, once a day for 15 weeks', 'armGroupLabels': ['Duloxetine']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'placebo capsules, oral, once a day for 15 weeks', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100088', 'city': 'Beijing', 'country': 'China', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '510370', 'city': 'Guangzhou', 'country': 'China', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '310009', 'city': 'Hangzhou', 'country': 'China', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'zip': '650032', 'city': 'Kunming', 'country': 'China', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 25.03889, 'lon': 102.71833}}, {'zip': '210029', 'city': 'Nanjing', 'country': 'China', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'zip': '200065', 'city': 'Shanghai', 'country': 'China', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '710032', 'city': "Xi'an", 'country': 'China', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}], 'overallOfficials': [{'name': 'Call 1-877-CTLILLY(1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM - 5 PM Eastern time(UTC/GMT -5 hours, EST)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eli Lilly and Company'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Chief Medical Officer', 'oldOrganization': 'Eli Lilly'}}}}