Ignite Creation Date:
2025-12-24 @ 10:53 PM
Ignite Modification Date:
2026-02-18 @ 3:46 AM
Study NCT ID:
NCT01944969
Status:
TERMINATED
Last Update Posted:
2018-10-17
First Post:
2013-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Long-term Safety and Tolerability Study of Brexpiprazole as Adjunctive Treatment in Patients With Major Depressive Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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': 'C000591922', 'term': 'brexpiprazole'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'LundbeckClinicalTrials@lundbeck.com', 'phone': '+45 36301311', 'title': 'H. Lundbeck A/S', 'organization': 'H. Lundbeck A/S'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Because the study was terminated, few efficacy data were collected. These data have not been reported in accordance with the ICH E3 regarding abbreviated clinical study reports. Furthermore, no firm conclusions can be drawn regarding safety.'}}, 'adverseEventsModule': {'timeFrame': 'From baseline to Week 52', 'eventGroups': [{'id': 'EG000', 'title': 'Brexpiprazole and ADT', 'description': 'Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant (ADT)\n\nBrexpiprazole: 1, 2, or 3 mg/day, once daily dose, tablets, orally', 'otherNumAtRisk': 26, 'otherNumAffected': 5, 'seriousNumAtRisk': 26, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Accidental overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Lethargy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Treatment-Emergent Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Brexpiprazole and ADT', 'description': 'Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant (ADT)\n\nBrexpiprazole: 1, 2, or 3 mg/day, once daily dose, tablets, orally'}], 'classes': [{'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From baseline to Week 52', 'description': 'Number of participants with Treatment-Emergent Adverse Events', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Withdrawals', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Brexpiprazole and ADT', 'description': 'Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant (ADT)\n\nBrexpiprazole: 1, 2, or 3 mg/day, once daily dose, tablets, orally'}], 'classes': [{'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From baseline to Week 52', 'description': 'Number of withdrawals', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': '26 patients were withdrawn; the reason for withdrawal was not poor tolerability, but mainly (23 patients) because the study was terminated. Please see withdrawn reasons in the participant flow section for the other reasons.'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Risk of Suicidality Assessed Using the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Brexpiprazole and ADT', 'description': 'Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant (ADT)\n\nBrexpiprazole: 1, 2, or 3 mg/day, once daily dose, tablets, orally'}], 'classes': [{'title': 'No suicidal ideation or behaviour', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}]}]}, {'title': 'Any non-suicidal self-injurious behavior', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Suicidal Ideation', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Preparatory action towards imminent suicidal', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Not fatal suicide attempt', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Completed suicide', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From baseline to Week 52', 'description': 'The Columbia Suicide Severity Rating Scale (eC-SSRS) is a semi-structured interview developed to systematically assess suicidal ideation and behaviour of patients participating in a clinical study. The C-SSRS has 5 questions addressing suicidal ideation, 5 sub-questions assessing the intensity of ideation, and 4 questions addressing suicidal behaviour. The electronic C-SSRS (eC-SSRS) is a patient-rated electronic version using interactive voice response technology. A structured CSSRS script of standardised questions, follow-up prompts, error-handling and scoring conventions is used for administration.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'all-patients treated set (APTS)'}, {'type': 'SECONDARY', 'title': 'Change in Depressive Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Brexpiprazole and ADT', 'description': 'Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant (ADT)\n\nBrexpiprazole: 1,2, or 3 mg/day, once daily dose, tablets, orally'}], 'timeFrame': 'From baseline to Week 52', 'description': 'The Montgomery and Aasberg Depression Rating Scale (MADRS) total score', 'reportingStatus': 'POSTED', 'populationDescription': 'None of the patients completed the study. A total of 26 patients were enrolled when the study was prematurely terminated(Planned: 1184 patients). No data were collected because none of the 26 patients that were enrolled completed the study because of early termination.'}, {'type': 'SECONDARY', 'title': 'Proportion of Patients in Remission', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Brexpiprazole and ADT', 'description': 'Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant (ADT)\n\nBrexpiprazole: 1, 2, or 3 mg/day, once daily dose, tablets, orally'}], 'timeFrame': 'From baseline to Week 52', 'description': 'Based on a pre-specified MADRS total score', 'reportingStatus': 'POSTED', 'populationDescription': 'No patients completed the study. Only 26 patients were enrolled at prematurely study termination (Planned: 1184 patients). No data were collected because none of the 26 patients that were enrolled completed the study because of early termination.'}, {'type': 'SECONDARY', 'title': 'Change in Clinical Global Impression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Brexpiprazole and ADT', 'description': 'Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant (ADT)\n\nBrexpiprazole: 1, 2, or 3 mg/day, once daily dose, tablets, orally'}], 'timeFrame': 'From baseline to Week 52', 'description': 'Clinical Global Impression - Severity of illness (CGI-S) score', 'reportingStatus': 'POSTED', 'populationDescription': 'No patients completed the study. Only 26 patients were enrolled at prematurely study termination (Planned: 1184 patients). No data were collected because none of the 26 patients that were enrolled completed the study because of early termination.'}, {'type': 'SECONDARY', 'title': 'Change in Health-related Quality of Life', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Brexpiprazole and ADT', 'description': 'Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant (ADT)\n\nBrexpiprazole: 1, 2, or 3 mg/day, once daily dose, tablets, orally'}], 'timeFrame': 'From baseline to Week 52', 'description': 'Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-(SF)) total score', 'reportingStatus': 'POSTED', 'populationDescription': 'No patients completed the study. Only 26 patients were enrolled at prematurely study termination (Planned: 1184 patients). No data were collected because none of the 26 patients that were enrolled completed the study because of early termination.'}, {'type': 'SECONDARY', 'title': 'Change in Health-related Quality of Life', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Brexpiprazole', 'description': 'Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant (ADT)\n\nBrexpiprazole: 1, 2, or 3 mg/day, once daily dose, tablets, orally'}], 'timeFrame': 'Baseline and Week 52', 'description': "The EuroQoL 5 Dimensions 5L version (EQ-5D-5L) Visual Analogue Scale (VAS) is a patient-reported assessment designed to measure the patient's wellbeing. It consists of 5 descriptive items (mobility, self-care, usual activities, pain/discomfort, and depression/anxiety) and a visual analogue scale (VAS) of the overall health state. Each descriptive item is rated on a 5-point index ranging from 1 (no problems) to 5 (extreme problems) and a single summary index (from 0 to 1) can be calculated. The VAS ranges from 0 (worst imaginable health state) to 100 (best imaginable health state).", 'reportingStatus': 'POSTED', 'populationDescription': 'No patients completed the study. Only 26 patients were enrolled at prematurely study termination (Planned: 1184 patients). No data were collected because none of the 26 patients that were enrolled completed the study because of early termination.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Brexpiprazole and ADT', 'description': 'Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant (ADT)\n\nBrexpiprazole: 1, 2, or 3 mg/day, once daily dose, tablets, orally'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Non-compliance with IMP', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Administrative or other reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '23'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Brexpiprazole and ADT', 'description': 'Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant (ADT)\n\nBrexpiprazole: 1, 2, or 3 mg/day, once daily dose, tablets, orally'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '23', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '66.12', 'spread': '10.03', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '21', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}, {'title': 'Slovakia', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'Sweden', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'Estonia', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}, {'title': 'Finland', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'whyStopped': 'The study was terminated because the lead-in study (14571A) in elderly was terminated; see Detailed Description.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-18', 'studyFirstSubmitDate': '2013-09-13', 'resultsFirstSubmitDate': '2015-08-17', 'studyFirstSubmitQcDate': '2013-09-13', 'lastUpdatePostDateStruct': {'date': '2018-10-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-02-04', 'studyFirstPostDateStruct': {'date': '2013-09-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-03-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Treatment-Emergent Adverse Events', 'timeFrame': 'From baseline to Week 52', 'description': 'Number of participants with Treatment-Emergent Adverse Events'}, {'measure': 'Number of Withdrawals', 'timeFrame': 'From baseline to Week 52', 'description': 'Number of withdrawals'}], 'secondaryOutcomes': [{'measure': 'Number of Patients With Risk of Suicidality Assessed Using the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS)', 'timeFrame': 'From baseline to Week 52', 'description': 'The Columbia Suicide Severity Rating Scale (eC-SSRS) is a semi-structured interview developed to systematically assess suicidal ideation and behaviour of patients participating in a clinical study. The C-SSRS has 5 questions addressing suicidal ideation, 5 sub-questions assessing the intensity of ideation, and 4 questions addressing suicidal behaviour. The electronic C-SSRS (eC-SSRS) is a patient-rated electronic version using interactive voice response technology. A structured CSSRS script of standardised questions, follow-up prompts, error-handling and scoring conventions is used for administration.'}, {'measure': 'Change in Depressive Symptoms', 'timeFrame': 'From baseline to Week 52', 'description': 'The Montgomery and Aasberg Depression Rating Scale (MADRS) total score'}, {'measure': 'Proportion of Patients in Remission', 'timeFrame': 'From baseline to Week 52', 'description': 'Based on a pre-specified MADRS total score'}, {'measure': 'Change in Clinical Global Impression', 'timeFrame': 'From baseline to Week 52', 'description': 'Clinical Global Impression - Severity of illness (CGI-S) score'}, {'measure': 'Change in Health-related Quality of Life', 'timeFrame': 'From baseline to Week 52', 'description': 'Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-(SF)) total score'}, {'measure': 'Change in Health-related Quality of Life', 'timeFrame': 'Baseline and Week 52', 'description': "The EuroQoL 5 Dimensions 5L version (EQ-5D-5L) Visual Analogue Scale (VAS) is a patient-reported assessment designed to measure the patient's wellbeing. It consists of 5 descriptive items (mobility, self-care, usual activities, pain/discomfort, and depression/anxiety) and a visual analogue scale (VAS) of the overall health state. Each descriptive item is rated on a 5-point index ranging from 1 (no problems) to 5 (extreme problems) and a single summary index (from 0 to 1) can be calculated. The VAS ranges from 0 (worst imaginable health state) to 100 (best imaginable health state)."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Major Depressive Disorder']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.clinicaltrialsregister.eu/ctr-search/trial/2012-004169-42/results', 'label': 'EudraCT (EMA) Result Posting'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the long-term safety and tolerability of brexpiprazole as adjunctive treatment in patients with Major Depressive Disorder (MDD)', 'detailedDescription': 'This extension safety study was terminated early because one of the lead-in studies (14571A) in elderly was terminated and because the Sponsor considered that sufficient long-term safety data has already been collected in the development programme in the population aged 18-65 yrs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* The patient is judged to benefit from adjunctive treatment with brexpiprazole according to the clinical opinion of the investigator.\n* The patient had MDD at entry in lead-in brexpiprazole studies, NCT01838681 / 14570A or NCT01837797 / 14571A, diagnosed according to DSM-IV-TR™.\n* The patient agrees to protocol-defined use of effective contraception.\n\nExclusion Criteria:\n\n* The patient has a disease or takes medication that could, in the investigator's opinion, interfere with the assessments of safety, tolerability, or efficacy, or interfere with the conduct or interpretation of the study.\n* The patient has been diagnosed with a psychiatric disorder other than MDD during the lead-in studies NCT01838681 / 14570A or NCT01837797 / 14571A.\n* The patient, in the opinion of the investigator or according to C-SSRS, is at significant risk of suicide.\n* The patient has any relevant medical history or current presence of systemic disease.\n* The patient has, at the Baseline Visit an abnormal ECG that is, in the investigator's opinion, clinically significant.\n* The patient has a moderate or severe ongoing adverse event related to study medication from the lead-in studies considered of potential safety risk by the investigator.\n* The patient is, in the investigator's opinion, unlikely to comply with the protocol or is unsuitable for any reason.\n\nOther inclusion and exclusion criteria may apply."}, 'identificationModule': {'nctId': 'NCT01944969', 'briefTitle': 'Long-term Safety and Tolerability Study of Brexpiprazole as Adjunctive Treatment in Patients With Major Depressive Disorder', 'organization': {'class': 'INDUSTRY', 'fullName': 'H. Lundbeck A/S'}, 'officialTitle': 'Interventional, Open-label, Long-term Extension Study to Evaluate the Safety and Tolerability of Brexpiprazole as Adjunctive Treatment in Patients With Major Depressive Disorder', 'orgStudyIdInfo': {'id': '14767B'}, 'secondaryIdInfos': [{'id': '2012-004169-42', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Brexpiprazole', 'description': 'Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant (ADT)', 'interventionNames': ['Drug: Brexpiprazole']}], 'interventions': [{'name': 'Brexpiprazole', 'type': 'DRUG', 'description': '1, 2, or 3 mg/day, once daily dose, tablets, orally. Uptitration in weekly steps from 0.5 mg/day (patients ≥65) or 1 mg/day (patients 18-64 years)', 'armGroupLabels': ['Brexpiprazole']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32806', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'US008', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}], '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'}, 'collaborators': [{'name': 'Otsuka Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}