Ignite Creation Date:
2025-12-24 @ 7:59 PM
Ignite Modification Date:
2025-12-28 @ 10:52 PM
Study NCT ID:
NCT00694304
Status:
COMPLETED
Last Update Posted:
2014-04-01
First Post:
2008-06-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Open-label Safety Extension Study of 2.5, 5 and 10 mg of Vortioxetine (Lu AA21004) in Long-term Treatment of Major Depressive Disorder in Adults
Sponsor:
Organization:
Raw JSON
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Lundbeck A/S', 'organization': 'H. Lundbeck A/S'}, 'certainAgreement': {'otherDetails': 'The main publication has to be published before any sub-publications. H. Lundbeck A/S follows the Vancouver declaration with respect to authorship.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Serious Adverse Events: 52-week open label period and 4-week safety follow-up period Other Adverse Events: 52-week open label period', 'eventGroups': [{'id': 'EG000', 'title': 'Vortioxetine 2.5, 5, or 10 mg/Day', 'otherNumAtRisk': 535, 'otherNumAffected': 256, 'seriousNumAtRisk': 535, 'seriousNumAffected': 18}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 535, 'numAffected': 106}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '12.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 535, 'numAffected': 27}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '12.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 535, 'numAffected': 56}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '12.1'}, {'term': 'Accidental overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 535, 'numAffected': 29}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '12.1'}, {'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 535, 'numAffected': 31}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '12.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 535, 'numAffected': 34}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '12.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 535, 'numAffected': 82}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '12.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 535, 'numAffected': 38}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '12.1'}], 'seriousEvents': [{'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 535, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '12.1'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 535, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '12.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 535, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '12.1'}, {'term': 'Intentional overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 535, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '12.1'}, {'term': 'Road traffic accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 535, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '12.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 535, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '12.1'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 535, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '12.1'}, {'term': 'Benign salivary gland neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 535, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '12.1'}, {'term': 'Adjustment disorder with mixed anxiety and depressed mood', 'stats': [{'groupId': 'EG000', 'numAtRisk': 535, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '12.1'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 535, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '12.1'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 535, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '12.1'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 535, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '12.1'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 535, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '12.1'}, {'term': 'Menorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 366, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '12.1'}, {'term': 'Dermatitis herpetiformis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 535, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '12.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Patients With Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '535', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Vortioxetine 2.5, 5, or 10 mg/Day', 'description': 'tablets; orally'}], 'classes': [{'title': 'Patients With AEs', 'categories': [{'measurements': [{'value': '391', 'groupId': 'OG000'}]}]}, {'title': 'Patients With SAEs', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}]}]}, {'title': 'Patients With AEs Leading to Withdrawal', 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to end of the 4-week safety follow-up period', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'APTS'}, {'type': 'PRIMARY', 'title': 'Percentage of Patients Who Withdrew Due to Intolerance to Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '535', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Vortioxetine 2.5, 5, or 10 mg/Day', 'description': 'tablets; orally'}], 'classes': [{'categories': [{'measurements': [{'value': '7.7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Week 52', 'unitOfMeasure': 'percentage of patients', 'reportingStatus': 'POSTED', 'populationDescription': 'APTS'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in MADRS Total Score After 52 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '329', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Vortioxetine 2.5, 5, or 10 mg/Day', 'description': 'tablets; orally'}], 'classes': [{'categories': [{'measurements': [{'value': '-7.35', 'spread': '8.21', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 52', 'description': 'The Montgomery Åsberg Depression Rating Scale (MADRS) is a depression rating scale consisting of 10 items, each rated 0 (no symptom) to 6 (severe symptom). The 10 items represent the core symptoms of depressive illness. The rating should be based on a clinical interview with the patient, moving from broadly phrased questions about symptoms to more detailed ones, which allow a precise rating of severity, covering the last 7 days. Total score from 0 to 60. The higher the score, the more severe.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS; observed cases (OC)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in HAM-D-24 Total Score After 52 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Vortioxetine 2.5, 5, or 10 mg/Day', 'description': 'tablets; orally'}], 'classes': [{'categories': [{'measurements': [{'value': '-6.86', 'spread': '8.45', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 52', 'description': 'The Hamilton Depression Scale - 24 Items (HAM-D-24) measures depression severity. Items are rated on a scale from 0 (symptoms not present) to a maximum of 2 to 4 (symptom extremely severe) for a total score range of 0 to 76. The higher the score, the more severe.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS; OC'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in HAM-A Total Score After 52 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Vortioxetine 2.5, 5, or 10 mg/Day', 'description': 'tablets; orally'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.44', 'spread': '7.08', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 52', 'description': 'The Hamilton Anxiety Rating Scale (HAM-A) consists of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behaviour at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic, and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total score from 0 to 56. The higher the score, the more severe.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS; OC'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in CGI-S Score After 52 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Vortioxetine 2.5, 5, or 10 mg/Day', 'description': 'tablets; orally'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.00', 'spread': '1.22', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 52', 'description': 'The Clinical Global Impression - Severity of Illness (CGI-S) is a 7-point scale rated from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). The investigator should use his/her total clinical experience with this patient population to judge how mentally ill the patient is at the time of rating.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS; OC'}, {'type': 'SECONDARY', 'title': 'Proportion of Responders at Week 52 (Response Defined as a >=50% Decrease in MADRS Total Score)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '329', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Vortioxetine 2.5, 5, or 10 mg/Day', 'description': 'tablets; orally'}], 'classes': [{'categories': [{'measurements': [{'value': '94.2', 'spread': '23.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 52', 'unitOfMeasure': 'percentage of patients', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS; OC; Baseline from lead-in study NCT00635219 / 11984A'}, {'type': 'SECONDARY', 'title': 'Proportion of Remitters at Week 52 (Remission Defined as a MADRS Total Score <=10)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '329', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Vortioxetine 2.5, 5, or 10 mg/Day', 'description': 'tablets; orally'}], 'classes': [{'categories': [{'measurements': [{'value': '83.0', 'spread': '37.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 52', 'unitOfMeasure': 'percentage of patients', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS; OC; Baseline from lead-in study NCT00635219 / 11984A'}, {'type': 'SECONDARY', 'title': 'Proportion of Patients With a MADRS Total Score >=22 After 52 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '329', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Vortioxetine 2.5, 5, or 10 mg/Day', 'description': 'tablets; orally'}], 'classes': [{'categories': [{'measurements': [{'value': '2.74', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 52', 'unitOfMeasure': 'percentage of patients', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS; OC'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in SDS Total Score After 52 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '285', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Vortioxetine 2.5, 5, or 10 mg/Day', 'description': 'tablets; orally'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.60', 'spread': '6.91', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 52', 'description': 'The Sheehan Disability Scale (SDS) comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scales, on which 0 = normal functioning and 10 = severe functional impairment. The three items may be summed into a single dimensional measure of global functional impairment that ranges from 0 (unimpaired) to 30 (highly impaired). The higher the score, the more severe.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS; OC'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Vortioxetine 2.5, 5, or 10 mg/Day', 'description': 'tablets; orally'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '535'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '328'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '207'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '42'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '35'}]}, {'type': 'Non-compliance With Study Product', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'Withdrawal of Consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '61'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '15'}]}, {'type': 'Administrative or Other Reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '32'}]}]}], 'recruitmentDetails': 'Patients eligible to participate in Study 11984B were patients who had completed lead-in Study NCT00635219 / 11984A immediately prior to inclusion into Study 11984B.', 'preAssignmentDetails': 'The study consisted of a 52-week open-label period and a 4-week Safety Follow-up Period.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '535', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Vortioxetine 2.5, 5, or 10 mg/Day', 'description': 'tablets; orally'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '45.7', 'spread': '12.3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '366', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '169', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'MADRS', 'classes': [{'categories': [{'measurements': [{'value': '13.5', 'spread': '8.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'The Montgomery Åsberg Depression Rating Scale (MADRS) is a depression rating scale consisting of 10 items, each rated 0 (no symptom) to 6 (severe symptom). The 10 items represent the core symptoms of depressive illness. The rating should be based on a clinical interview with the patient, moving from broadly phrased questions about symptoms to more detailed ones, which allow a precise rating of severity, covering the last 7 days. Total score from 0 to 60. The higher the score, the more severe.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'HAM-D-24', 'classes': [{'categories': [{'measurements': [{'value': '13.4', 'spread': '8.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'The Hamilton Depression Scale - 24 Items (HAM-D-24) measures depression severity. Items are rated on a scale from 0 (symptoms not present) to a maximum of 2 to 4 (symptom extremely severe) for a total score range of 0 to 76. The higher the score, the more severe.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'HAM-A', 'classes': [{'categories': [{'measurements': [{'value': '11.0', 'spread': '7.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'The Hamilton Anxiety Rating Scale (HAM-A) consists of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behaviour at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic, and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total score from 0 to 56. The higher the score, the more severe.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'CGI-S', 'classes': [{'categories': [{'measurements': [{'value': '2.7', 'spread': '1.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'The Clinical Global Impression - Severity of Illness (CGI-S) is a 7-point scale rated from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). The investigator should use his/her total clinical experience with this patient population to judge how mentally ill the patient is at the time of rating.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'SDS', 'classes': [{'categories': [{'measurements': [{'value': '12.42', 'spread': '8.13', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'The Sheehan Disability Scale (SDS) comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scales, on which 0 = normal functioning and 10 = severe functional impairment. The three items may be summed into a single dimensional measure of global functional impairment that ranges from 0 (unimpaired) to 30 (highly impaired). The higher the score, the more severe.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Age and Sex: all-patients-treated set (APTS) - all patients who took at least one dose of Vortioxetine after Baseline; MADRS, HAM-D-24, HAM-A, CGI-S and SDS: full-analysis set (FAS) - all patients in the APTS who had at least one valid post-Baseline assessment of the MADRS total score.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 535}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-02-17', 'studyFirstSubmitDate': '2008-06-06', 'resultsFirstSubmitDate': '2013-10-28', 'studyFirstSubmitQcDate': '2008-06-09', 'lastUpdatePostDateStruct': {'date': '2014-04-01', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-02-17', 'studyFirstPostDateStruct': {'date': '2008-06-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-04-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Patients With Adverse Events (AEs)', 'timeFrame': 'Baseline to end of the 4-week safety follow-up period'}, {'measure': 'Percentage of Patients Who Withdrew Due to Intolerance to Treatment', 'timeFrame': 'Baseline to Week 52'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in MADRS Total Score After 52 Weeks of Treatment', 'timeFrame': 'Baseline and Week 52', 'description': 'The Montgomery Åsberg Depression Rating Scale (MADRS) is a depression rating scale consisting of 10 items, each rated 0 (no symptom) to 6 (severe symptom). The 10 items represent the core symptoms of depressive illness. The rating should be based on a clinical interview with the patient, moving from broadly phrased questions about symptoms to more detailed ones, which allow a precise rating of severity, covering the last 7 days. Total score from 0 to 60. The higher the score, the more severe.'}, {'measure': 'Change From Baseline in HAM-D-24 Total Score After 52 Weeks of Treatment', 'timeFrame': 'Baseline and Week 52', 'description': 'The Hamilton Depression Scale - 24 Items (HAM-D-24) measures depression severity. Items are rated on a scale from 0 (symptoms not present) to a maximum of 2 to 4 (symptom extremely severe) for a total score range of 0 to 76. The higher the score, the more severe.'}, {'measure': 'Change From Baseline in HAM-A Total Score After 52 Weeks of Treatment', 'timeFrame': 'Baseline and Week 52', 'description': 'The Hamilton Anxiety Rating Scale (HAM-A) consists of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behaviour at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic, and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total score from 0 to 56. The higher the score, the more severe.'}, {'measure': 'Change From Baseline in CGI-S Score After 52 Weeks of Treatment', 'timeFrame': 'Baseline and Week 52', 'description': 'The Clinical Global Impression - Severity of Illness (CGI-S) is a 7-point scale rated from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). The investigator should use his/her total clinical experience with this patient population to judge how mentally ill the patient is at the time of rating.'}, {'measure': 'Proportion of Responders at Week 52 (Response Defined as a >=50% Decrease in MADRS Total Score)', 'timeFrame': 'Week 52'}, {'measure': 'Proportion of Remitters at Week 52 (Remission Defined as a MADRS Total Score <=10)', 'timeFrame': 'Week 52'}, {'measure': 'Proportion of Patients With a MADRS Total Score >=22 After 52 Weeks of Treatment', 'timeFrame': 'Baseline and Week 52'}, {'measure': 'Change From Baseline in SDS Total Score After 52 Weeks of Treatment', 'timeFrame': 'Baseline and Week 52', 'description': 'The Sheehan Disability Scale (SDS) comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scales, on which 0 = normal functioning and 10 = severe functional impairment. The three items may be summed into a single dimensional measure of global functional impairment that ranges from 0 (unimpaired) to 30 (highly impaired). The higher the score, the more severe.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Major Depressive Disorder', 'Long-term', 'Safety', 'Open-label'], 'conditions': ['Major Depressive Disorder']}, 'referencesModule': {'references': [{'pmid': '22978748', 'type': 'RESULT', 'citation': 'Baldwin DS, Hansen T, Florea I. Vortioxetine (Lu AA21004) in the long-term open-label treatment of major depressive disorder. Curr Med Res Opin. 2012 Oct;28(10):1717-24. doi: 10.1185/03007995.2012.725035. Epub 2012 Sep 17.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to evaluate long-term safety and tolerability of Vortioxetine over a period of 52 weeks in patients with Major Depressive Disorder (MDD) having completed 8-week acute treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Patients who completed 8-week short-term treatment study for Major Depressive Episode, NCT00635219 / 11984A\n\nExclusion Criteria:\n\n* Any current psychiatric disorder other than MDD as defined in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Ed., Text revision (DSM-IV TR)\n* Female patients of childbearing potential who are not using effective contraception\n* Use of any psychoactive medication\n\nOther protocol-defined inclusion and exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT00694304', 'briefTitle': 'Open-label Safety Extension Study of 2.5, 5 and 10 mg of Vortioxetine (Lu AA21004) in Long-term Treatment of Major Depressive Disorder in Adults', 'organization': {'class': 'INDUSTRY', 'fullName': 'H. Lundbeck A/S'}, 'officialTitle': 'A Long-term, Open-label, Flexible-dose, Extension Study Evaluating the Safety and Tolerability of [Vortioxetine] Lu AA21004 in Patients With Major Depressive Disorder', 'orgStudyIdInfo': {'id': '11984B'}, 'secondaryIdInfos': [{'id': 'EudraCT 2007-004992-21', 'type': 'REGISTRY', 'domain': 'EudraCT'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vortioxetine', 'interventionNames': ['Drug: Vortioxetine (Lu AA21004)']}], 'interventions': [{'name': 'Vortioxetine (Lu AA21004)', 'type': 'DRUG', 'otherNames': ['Brintellix'], 'description': '2.5, 5, or 10 mg/day; tablets; orally', 'armGroupLabels': ['Vortioxetine']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Email contact via H. Lundbeck A/S', 'role': 'STUDY_DIRECTOR', 'affiliation': 'LundbeckClinicalTrials@lundbeck.com'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'H. Lundbeck A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}