Ignite Creation Date:
2025-12-24 @ 11:59 AM
Ignite Modification Date:
2025-12-31 @ 8:44 PM
Study NCT ID:
NCT02116361
Status:
COMPLETED
Last Update Posted:
2017-12-19
First Post:
2014-04-15
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
OnabotulinumtoxinA as Treatment for Major Depressive Disorder in Adult Females
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': 'D019274', 'term': 'Botulinum Toxins, Type A'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D001905', 'term': 'Botulinum Toxins'}, {'id': 'D008666', 'term': 'Metalloendopeptidases'}, {'id': 'D010450', 'term': 'Endopeptidases'}, {'id': 'D010447', 'term': 'Peptide Hydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D045726', 'term': 'Metalloproteases'}, {'id': 'D001426', 'term': 'Bacterial Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D001427', 'term': 'Bacterial Toxins'}, {'id': 'D014118', 'term': 'Toxins, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'lum_arlene@allergan.com', 'phone': '714-246-5548', 'title': 'Arlene Lum, PMP', 'organization': 'Allergan, Inc'}, 'certainAgreement': {'otherDetails': 'A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'The Safety Population was used to assess AEs and SAEs and consisted of all randomized patients who received at least 1 injection of the study treatment', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo (Normal Saline) for onabotulinumtoxinA 50 U', 'description': 'Placebo (normal saline) for onabotulinumtoxinA 50 U injected into protocol-specified areas on Day 1.', 'otherNumAtRisk': 67, 'otherNumAffected': 21, 'seriousNumAtRisk': 67, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': 'onabotulinumtoxinA 50 U', 'description': 'OnabotulinumtoxinA 50 U injected into protocol-specified areas on Day 1.', 'otherNumAtRisk': 65, 'otherNumAffected': 18, 'seriousNumAtRisk': 65, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Placebo (Normal Saline) for onabotulinumtoxinA 30 U', 'description': 'Placebo (normal saline) for onabotulinumtoxinA 30 U injected into protocol-specified areas on Day 1.', 'otherNumAtRisk': 58, 'otherNumAffected': 10, 'seriousNumAtRisk': 58, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'onabotulinumtoxinA 30 U', 'description': 'OnabotulinumtoxinA 30 U injected into protocol-specified areas on Day 1.', 'otherNumAtRisk': 65, 'otherNumAffected': 21, 'seriousNumAtRisk': 65, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.1'}, {'term': 'URI', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 9}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.1'}, {'term': 'Eyelid Ptosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 4}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.1'}], 'seriousEvents': [{'term': 'Fibula Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.1'}, {'term': 'Foot Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.1'}, {'term': 'Ligament Rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.1'}, {'term': 'Hallucination, Auditory', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.1'}, {'term': 'Suicidal Ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.1'}, {'term': 'Varicose Vein', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.1'}, {'term': 'Sudden Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.1'}, {'term': 'Benign Breast Neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.1'}, {'term': 'Cerebrovascular Accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Baseline Values for the Clinic 10-Item Montgomery-Asberg Depression Rating Scale (MADRS) Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}, {'value': '65', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (Normal Saline) for onabotulinumtoxinA 30 U', 'description': 'Placebo (normal saline) for onabotulinumtoxinA 30 U injected into protocol-specified areas on Day 1.'}, {'id': 'OG001', 'title': 'onabotulinumtoxinA 30 U', 'description': 'OnabotulinumtoxinA 30 U injected into protocol-specified areas on Day 1.'}, {'id': 'OG002', 'title': 'Placebo (Normal Saline) for onabotulinumtoxinA 50 U', 'description': 'Placebo (normal saline) for onabotulinumtoxinA 50 U injected into protocol-specified areas on Day 1.'}, {'id': 'OG003', 'title': 'onabotulinumtoxinA 50 U', 'description': 'OnabotulinumtoxinA 50 U injected into protocol-specified areas on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '31.4', 'spread': '3.99', 'groupId': 'OG000'}, {'value': '32.0', 'spread': '4.12', 'groupId': 'OG001'}, {'value': '32.4', 'spread': '5.34', 'groupId': 'OG002'}, {'value': '32.0', 'spread': '4.44', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': "The MADRS is a 10-item scale completed by clinic personnel that assesses the subject's symptoms of depression. 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A negative change from baseline indicates an improvement in symptoms and a positive change from baseline indicates a worsening.", 'unitOfMeasure': 'Scores on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent to Treat: Enrolled subjects who received treatment with data at the noted time point'}, {'type': 'PRIMARY', 'title': 'Change From Baseline Values in the Clinic 10-Item Montgomery-Asberg Depression Rating Scale (MADRS) Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}, {'value': '65', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (Normal Saline) for onabotulinumtoxinA 30 U', 'description': 'Placebo (normal saline) for onabotulinumtoxinA 30 U injected into protocol-specified areas on Day 1.'}, {'id': 'OG001', 'title': 'onabotulinumtoxinA 30 U', 'description': 'OnabotulinumtoxinA 30 U injected into protocol-specified areas on Day 1.'}, {'id': 'OG002', 'title': 'Placebo (Normal Saline) for onabotulinumtoxinA 50 U', 'description': 'Placebo (normal saline) for onabotulinumtoxinA 50 U injected into protocol-specified areas on Day 1.'}, {'id': 'OG003', 'title': 'onabotulinumtoxinA 50 U', 'description': 'OnabotulinumtoxinA 50 U injected into protocol-specified areas on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '-7.9', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '-11.6', 'spread': '1.4', 'groupId': 'OG001'}, {'value': '-12.9', 'spread': '1.2', 'groupId': 'OG002'}, {'value': '-11.5', 'spread': '1.2', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 6', 'description': "The MADRS is a 10-item scale completed by clinic personnel that assesses the subject's symptoms of depression. Each question is answered on a 7-point scale ranging from no symptoms to worst possible symptoms. The total score is summed for all responses and ranges from 0 to 60. 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Scores range from 1 to 7, from normal (1, not at all ill) to among the most extremely ill patients (7). 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Scores range from 1 to 7, from normal (1, not at all ill) to among the most extremely ill patients (7). 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The total scores range from 0 to 53. A higher total score indicates more severe depression. A negative change from baseline indicates an improvement in symptoms and a positive change from baseline indicates a worsening.', 'unitOfMeasure': 'Scores on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent to Treat: Enrolled subjects who received treatment with data at the noted time point'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Values in the Clinic Hamilton Depression Rating Scale 17-Item Version (HAM-D17)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (Normal Saline) for onabotulinumtoxinA 30 U', 'description': 'Placebo (normal saline) for onabotulinumtoxinA 30 U injected into protocol-specified areas on Day 1.'}, {'id': 'OG001', 'title': 'onabotulinumtoxinA 30 U', 'description': 'OnabotulinumtoxinA 30 U injected into protocol-specified areas on Day 1.'}, {'id': 'OG002', 'title': 'Placebo (Normal Saline) for onabotulinumtoxinA 50 U', 'description': 'Placebo (normal saline) for onabotulinumtoxinA 50 U injected into protocol-specified areas on Day 1.'}, {'id': 'OG003', 'title': 'onabotulinumtoxinA 50 U', 'description': 'OnabotulinumtoxinA 50 U injected into protocol-specified areas on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '-11.5', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '-13.4', 'spread': '1.1', 'groupId': 'OG001'}, {'value': '-16.1', 'spread': '0.8', 'groupId': 'OG002'}, {'value': '-17.4', 'spread': '0.8', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '24 Weeks', 'description': 'The HAM-D17 is assessed by the clinician based on subject interview. 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