Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2026-04-09 @ 7:44 AM
Study NCT ID:
NCT01987960
Status:
TERMINATED
Last Update Posted:
2017-03-13
First Post:
2013-11-13
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Brexpiprazole as an Adjunctive Treatment to Paroxetine or Sertraline in Adult Patients Suffering From Post-traumatic Stress Disorder (PTSD)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}], 'ancestors': [{'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000591922', 'term': 'brexpiprazole'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'LundbeckClinicalTrials@Lundbeck.com', 'title': 'H. Lundbeck', 'organization': 'A/S'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'As the study was terminated limited efficacy and safety data were collected from the randomized patients. The data are descriptive and the primary and key secondary efficacy analyses were not done.'}}, 'adverseEventsModule': {'timeFrame': 'Period 2: Baseline to Week 16 (randomized period)', 'eventGroups': [{'id': 'EG000', 'title': 'Brexpiprazole + PAR/SER (Randomized Period)', 'otherNumAtRisk': 23, 'otherNumAffected': 3, 'seriousNumAtRisk': 23, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo + PAR/SER (Randomized Period)', 'otherNumAtRisk': 17, 'otherNumAffected': 8, 'seriousNumAtRisk': 17, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Accidental overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Tendon rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Hypercholesterolaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Disturbance in attention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Galactorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'PTSD Symptoms Using CAPS-2 Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Period 2 Absolute Mean at Baseline; Placebo and PAR/SER', 'description': 'Period 2 absolute mean value at Baseline; Randomized placebo adjunct to open-label treatment with a commercially available approved treatment for PTSD (PAR/SER); randomized period.\n\nPlacebo: Once daily, tablets, orally'}, {'id': 'OG001', 'title': 'Period 2 Absolute Mean at Baseline; Brexpiprazole and PAR/SER', 'description': 'Period 2 absolute mean value at Baseline; Randomized brexpiprazole adjunct to open-label treatment with a commercially available approved treatment for PTSD (PAR/SER). Brexpiprazole dosing was 1mg/day for one week, followed by 2mg/day for 3 weeks. Thereafter the dose was flexible and could be adjusted from 1 to 3 mg/day; randomized period.\n\nBrexpiprazole: 1 to 3 mg/day, once daily dose, tablets, orally'}, {'id': 'OG002', 'title': 'Period 2 Absolute Mean at Week 12; Placebo and PAR/SER', 'description': 'Period 2 absolute mean value at Week 12; Randomized placebo adjunct to open-label treatment with a commercially available approved treatment for PTSD (PAR/SER); randomized period.\n\nPlacebo: Once daily, tablets, orally\n\nAbsolute values at Week 12 in Period 2 (Study Week 24)'}, {'id': 'OG003', 'title': 'Period 2 Absolute Mean at Week 12; Brexpiprazole and PAR/SER', 'description': 'Period 2 absolute mean value at Week 12; Randomized brexpiprazole adjunct to open-label treatment with a commercially available approved treatment for PTSD (PAR/SER). Brexpiprazole dosing was 1mg/day for one week, followed by 2mg/day for 3 weeks. Thereafter the dose was flexible and could be adjusted from 1 to 3 mg/day; randomized period.\n\nBrexpiprazole: 1 to 3 mg/day, once daily dose, tablets, orally\n\nAbsolute values at Week 12 in Period 2 (Study Week 24)'}], 'classes': [{'categories': [{'measurements': [{'value': '82.82', 'spread': '12.94', 'groupId': 'OG000'}, {'value': '83.43', 'spread': '13.12', 'groupId': 'OG001'}, {'value': '69.67', 'spread': '20.26', 'groupId': 'OG002'}, {'value': '69.18', 'spread': '18.17', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Period 2: Baseline to Week 12 (of randomized period)', 'description': 'Clinician-Administered PTSD Scale Part 2 (CAPS-2): 17 items in criteria B, C and D (Corresponding to CAPS-2) will be administered to provide a total score. They are rated on a 5 point scale for frequency from 0 (never or none) to 4 (daily or almost every day), and intensity from 0 (none) to 4 (extreme). The sum of the 17 items gives a toal score ranging from 0 to 136, with a higher score indicating greater symptom severity.', 'unitOfMeasure': 'Score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Due to the low number of enrolled patients eligible for randomization and the sponsor's early termination of the study, the data presented are descriptive i.e. the primary and key secondary efficacy analyses were not done"}, {'type': 'SECONDARY', 'title': 'Global Clinical Impression Severity of Illness (CGI-S) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Period 2 Absolute Mean at Baseline; Placebo and PAR/SER', 'description': 'Period 2 absolute mean value at Baseline; Randomized placebo adjunct to open-label treatment with a commercially available approved treatment for PTSD (PAR/SER); randomized period.\n\nPlacebo: Once daily, tablets, orally'}, {'id': 'OG001', 'title': 'Period 2 Absolute Mean at Baseline; Brexpiprazole and PAR/SER', 'description': 'Period 2 absolute mean value at Baseline; Randomized brexpiprazole adjunct to open-label treatment with a commercially available approved treatment for PTSD (PAR/SER). Brexpiprazole dosing was 1mg/day for one week, followed by 2mg/day for 3 weeks. Thereafter the dose was flexible and could be adjusted from 1 to 3 mg/day; randomized period.\n\nBrexpiprazole: 1 to 3 mg/day, once daily dose, tablets, orally'}, {'id': 'OG002', 'title': 'Period 2 Absolute Mean at Week 12; Placebo and PAR/SER', 'description': 'Period 2 absolute mean value at Week 12; Randomized placebo adjunct to open-label treatment with a commercially available approved treatment for PTSD (PAR/SER) Placebo: Once daily, tablets, orally Absolute values at Week 12 in Period 2 (Study Week 24); randomized period.'}, {'id': 'OG003', 'title': 'Period 2 Absolute Mean at Week 12; Brexpiprazole and PAR/SER', 'description': 'Period 2 absolute mean value at Week 12; Randomized brexpiprazole adjunct to open-label treatment with a commercially available approved treatment for PTSD (PAR/SER); randomized period.\n\nBrexpiprazole dosing was 1mg/day for one week, followed by 2mg/day for 3 weeks. Thereafter the dose was flexible and could be adjusted from 1 to 3 mg/day. Brexpiprazole: 1 to 3 mg/day, once daily dose, tablets, orally Absolute values at Week 12 in Period 2 (Study Week 24).'}], 'classes': [{'categories': [{'measurements': [{'value': '4.24', 'spread': '0.83', 'groupId': 'OG000'}, {'value': '4.54', 'spread': '0.73', 'groupId': 'OG001'}, {'value': '3.73', 'spread': '1.10', 'groupId': 'OG002'}, {'value': '3.94', 'spread': '0.83', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Period 2: Baseline to Week 12 (of randomized period)', 'description': "Clinical Global Impression - Severity of Illness (CGI-S) The CGI-S provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (Normal - not at all ill) to 7 (among the most extremely ill patients).", 'unitOfMeasure': 'Score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Due to the low number of enrolled patients eligible for randomization and the sponsor's early termination of the study, the data presented are descriptive i.e. the primary and key secondary efficacy analyses were not done."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Period 1 Placebo and PAR/SER', 'description': 'Placebo adjunct to open-label treatment with a commercially available approved treatment for PTSD (PAR/SER).\n\nPlacebo: Once daily, tablets, orally'}, {'id': 'FG001', 'title': 'Period 2 Placebo and PAR/SER (Randomized Period)', 'description': 'Randomized placebo adjunct to open-label treatment with a commercially available approved treatment for PTSD (PAR/SER); randomized period.\n\nPlacebo: Once daily, tablets, orally'}, {'id': 'FG002', 'title': 'Period 2 Brexpiprazole and PAR/SER (Randomized Period)', 'description': 'Randomized brexpiprazole adjunct to open-label treatment with a commercially available approved treatment for PTSD (PAR/SER). Brexpiprazole dosing was 1mg/day for one week, followed by 2mg/day for 3 weeks. Thereafter the dose was flexible and could be adjusted from 1 to 3 mg/day; randomized period\n\nBrexpiprazole: 1 to 3 mg/day, once daily dose, tablets, orally'}, {'id': 'FG003', 'title': 'Period 3 Placebo and PAR/SER', 'description': 'Continuation of treatment with placebo adjunct to open-label treatment with a commercially available approved treatment for PTSD (PAR/SER) from Period 1.\n\nPlacebo: Once daily, tablets, orally'}], 'periods': [{'title': 'Period 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '417'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '231'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '186'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Non-compliance with IMP', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'administrative or other reason', 'reasons': [{'groupId': 'FG000', 'numSubjects': '75'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Withdrawal of consent before treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Period 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '17'}, {'groupId': 'FG002', 'numSubjects': '23'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '14'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Administrative or other reason', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Period 3', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '190'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '119'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '71'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '7'}]}, {'type': 'Non-compliance with IMP', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '6'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '9'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'Administrative or other reason', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '43'}]}]}], 'recruitmentDetails': '417 patients were enrolled to the study and 413 patients received open-label treatment with a commercially available treatment for PTSD (PAR/SER) in Period 1. Only 40 patients were randomized to Period 2, the randomized period, before the study was terminated; 190 patients entered Period 3. Data are only reported for the randomized period.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Period 2 Placebo and PAR/SER (Randomized Period)', 'description': 'Randomized placebo adjunct to open-label treatment with a commercially available approved treatment for PTSD (PAR/SER); randomized period.\n\nPlacebo: Once daily, tablets, orally'}, {'id': 'BG001', 'title': 'Period 2 Brexpiprazole and PAR/SER (Randomized Period)', 'description': 'Randomized brexpiprazole adjunct to open-label treatment with a commercially available approved treatment for PTSD (PAR/SER). Brexpiprazole dosing was 1mg/day for one week, followed by 2mg/day for 3 weeks. Thereafter the dose was flexible and could be adjusted from 1 to 3 mg/day; randomized period.\n\nBrexpiprazole: 1 to 3 mg/day, once daily dose, tablets, orally'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '42.9', 'spread': '11.8', 'groupId': 'BG000'}, {'value': '47.6', 'spread': '10.4', 'groupId': 'BG001'}, {'value': '45.6', 'spread': '11.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The all-patients-treated set (APTS) comprises all randomized patients who took at least one dose of brexpiprazole or placebo.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 417}}, 'statusModule': {'whyStopped': 'The study was terminated due to challenges with patient eligibility; the decision to terminate was not based on any safety concerns', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-23', 'studyFirstSubmitDate': '2013-11-13', 'resultsFirstSubmitDate': '2016-10-28', 'studyFirstSubmitQcDate': '2013-11-19', 'lastUpdatePostDateStruct': {'date': '2017-03-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-01-23', 'studyFirstPostDateStruct': {'date': '2013-11-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PTSD Symptoms Using CAPS-2 Total Score', 'timeFrame': 'Period 2: Baseline to Week 12 (of randomized period)', 'description': 'Clinician-Administered PTSD Scale Part 2 (CAPS-2): 17 items in criteria B, C and D (Corresponding to CAPS-2) will be administered to provide a total score. They are rated on a 5 point scale for frequency from 0 (never or none) to 4 (daily or almost every day), and intensity from 0 (none) to 4 (extreme). The sum of the 17 items gives a toal score ranging from 0 to 136, with a higher score indicating greater symptom severity.'}], 'secondaryOutcomes': [{'measure': 'Global Clinical Impression Severity of Illness (CGI-S) Score', 'timeFrame': 'Period 2: Baseline to Week 12 (of randomized period)', 'description': "Clinical Global Impression - Severity of Illness (CGI-S) The CGI-S provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (Normal - not at all ill) to 7 (among the most extremely ill patients)."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Post-traumatic Stress Disorder', 'PTSD']}, 'descriptionModule': {'briefSummary': 'To evaluate the efficacy of brexpiprazole as adjunctive treatment to paroxetine (PAR) or sertraline (SER) on PTSD symptoms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* The patient has PTSD, diagnosed according to DSM-IV-TR™ and confirmed by the Mini International Neuropsychiatric Interview (MINI).\n* The patient has a Clinician-Administered PTSD Scale Part 2 (CAPS-2) total score ≥70 at Screening and Baseline Visits.\n* The reported duration of the PTSD is at least 3 months.\n\nExclusion Criteria:\n\n* The index traumatic event that led to development of PTSD took place more than 15 years before screening.\n* The patient has a severe personality disorder that in the investigator's opinion may interfere with the conduct of the study.\n* The patient is at significant suicidal risk.\n\nOther inclusion and exclusion criteria may apply."}, 'identificationModule': {'nctId': 'NCT01987960', 'briefTitle': 'Brexpiprazole as an Adjunctive Treatment to Paroxetine or Sertraline in Adult Patients Suffering From Post-traumatic Stress Disorder (PTSD)', 'organization': {'class': 'INDUSTRY', 'fullName': 'H. Lundbeck A/S'}, 'officialTitle': 'Interventional, Randomised, Double-blind, Parallel-group, Placebo-controlled, Flexible-dose Study of Brexpiprazole as Adjunctive Treatment to Paroxetine or Sertraline in Adult Patients Suffering From Post-traumatic Stress Disorder (PTSD)', 'orgStudyIdInfo': {'id': '14865A'}, 'secondaryIdInfos': [{'id': '2012-004982-41', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo adjunct to open-label treatment with a commercially available approved treatment for PTSD (PAR/SER)', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Brexpiprazole', 'description': 'Brexpiprazole adjunct to open-label treatment with a commercially available approved treatment for PTSD (PAR/SER). Brexpiprazole dosing was 1mg/day for one week, followed by 2mg/day for 3 weeks. Thereafter the dose was flexible and could be adjusted from 1 to 3 mg/day.', 'interventionNames': ['Drug: Brexpiprazole']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': 'Once daily, tablets, orally', 'armGroupLabels': ['Placebo']}, {'name': 'Brexpiprazole', 'type': 'DRUG', 'description': '1 to 3 mg/day, once daily dose, tablets, orally', 'armGroupLabels': ['Brexpiprazole']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90024', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'US004', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90102', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'US025', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92504', 'city': 'Riverside', 'state': 'California', 'country': 'United States', 'facility': 'US024', 'geoPoint': {'lat': 33.95335, 'lon': -117.39616}}, {'zip': '90103', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'US015', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'US008', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '34201', 'city': 'Bradenton', 'state': 'Florida', 'country': 'United States', 'facility': 'US002', 'geoPoint': {'lat': 27.49893, 'lon': -82.57482}}, {'zip': '32607', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'US006', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '32256', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'US016', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '33161', 'city': 'North Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'US020', 'geoPoint': {'lat': 25.89009, 'lon': -80.18671}}, {'zip': '33609', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'US017', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '46260', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'US012', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '02131', 'city': 'Roslindale', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'US021', 'geoPoint': {'lat': 42.29121, 'lon': -71.1245}}, {'zip': '89102', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'US019', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '03060', 'city': 'Nashua', 'state': 'New Hampshire', 'country': 'United States', 'facility': 'US007', 'geoPoint': {'lat': 42.76537, 'lon': -71.46757}}, {'zip': '10467', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'US001', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '45219', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'US009', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '45417', 'city': 'Dayton', 'state': 'Ohio', 'country': 'United States', 'facility': 'US005', 'geoPoint': {'lat': 39.75895, 'lon': -84.19161}}, {'zip': '97210', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'US010', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '19403', 'city': 'Norristown', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'US014', 'geoPoint': {'lat': 40.1215, 'lon': -75.3399}}, {'zip': '38119', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'US011', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '78731', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'US003', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '98104', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'US026', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'city': 'Tallinn', 'country': 'Estonia', 'facility': 'EE001', 'geoPoint': {'lat': 59.43696, 'lon': 24.75353}}, {'city': 'Helsinki', 'country': 'Finland', 'facility': 'FI002', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}, {'city': 'Helsinki', 'country': 'Finland', 'facility': 'FI003', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}, {'city': 'Kuopio', 'country': 'Finland', 'facility': 'FI001', 'geoPoint': {'lat': 62.89238, 'lon': 27.67703}}, {'city': 'Oulu', 'country': 'Finland', 'facility': 'FI006', 'geoPoint': {'lat': 65.01236, 'lon': 25.46816}}, {'city': 'Tampere', 'country': 'Finland', 'facility': 'FI005', 'geoPoint': {'lat': 61.49911, 'lon': 23.78712}}, {'city': 'Turku', 'country': 'Finland', 'facility': 'FI004', 'geoPoint': {'lat': 60.45148, 'lon': 22.26869}}, {'city': 'Fort de France', 'country': 'France', 'facility': 'FR002'}, {'city': 'Laxou', 'country': 'France', 'facility': 'FR003', 'geoPoint': {'lat': 48.68372, 'lon': 6.14929}}, {'city': 'Nîmes', 'country': 'France', 'facility': 'FR004', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}, {'city': 'Thuir', 'country': 'France', 'facility': 'FR005', 'geoPoint': {'lat': 42.6322, 'lon': 2.75577}}, {'city': 'Tours', 'country': 'France', 'facility': 'FR001', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}, {'city': 'Andria', 'country': 'Italy', 'facility': 'IT005', 'geoPoint': {'lat': 41.23117, 'lon': 16.29797}}, {'city': 'Catania', 'country': 'Italy', 'facility': 'IT004', 'geoPoint': {'lat': 37.49223, 'lon': 15.07041}}, {'city': 'Lecce', 'country': 'Italy', 'facility': 'IT003', 'geoPoint': {'lat': 40.35481, 'lon': 18.17244}}, {'city': 'Pisa', 'country': 'Italy', 'facility': 'IT001', 'geoPoint': {'lat': 43.70853, 'lon': 10.4036}}, {'city': 'Siena', 'country': 'Italy', 'facility': 'IT002', 'geoPoint': {'lat': 43.31822, 'lon': 11.33064}}, {'city': 'Bialystok', 'country': 'Poland', 'facility': 'PL003', 'geoPoint': {'lat': 53.13333, 'lon': 23.16433}}, {'city': 'Gdansk', 'country': 'Poland', 'facility': 'PL004', 'geoPoint': {'lat': 54.35227, 'lon': 18.64912}}, {'city': 'Gdansk', 'country': 'Poland', 'facility': 'PL005', 'geoPoint': {'lat': 54.35227, 'lon': 18.64912}}, {'city': 'Leszno', 'country': 'Poland', 'facility': 'PL001', 'geoPoint': {'lat': 51.84034, 'lon': 16.57494}}, {'city': 'Lublin', 'country': 'Poland', 'facility': 'PL002', 'geoPoint': {'lat': 51.25058, 'lon': 22.57009}}, {'city': 'Belgrade', 'country': 'Serbia', 'facility': 'RS006', 'geoPoint': {'lat': 44.80401, 'lon': 20.46513}}, {'city': 'Niš', 'country': 'Serbia', 'facility': 'RS004', 'geoPoint': {'lat': 43.32472, 'lon': 21.90333}}, {'city': 'Novi Kneževac', 'country': 'Serbia', 'facility': 'RS005', 'geoPoint': {'lat': 46.05, 'lon': 20.1}}, {'city': 'Bloemfontein', 'country': 'South Africa', 'facility': 'ZA006', 'geoPoint': {'lat': -29.12107, 'lon': 26.214}}, {'city': 'Cape Town', 'country': 'South Africa', 'facility': 'ZA002', 'geoPoint': {'lat': -33.92584, 'lon': 18.42322}}, {'city': 'Cape Town', 'country': 'South Africa', 'facility': 'ZA003', 'geoPoint': {'lat': -33.92584, 'lon': 18.42322}}, {'city': 'Cape Town', 'country': 'South Africa', 'facility': 'ZA004', 'geoPoint': {'lat': -33.92584, 'lon': 18.42322}}, {'city': 'Cape Town', 'country': 'South Africa', 'facility': 'ZA005', 'geoPoint': {'lat': -33.92584, 'lon': 18.42322}}, {'city': 'Durban', 'country': 'South Africa', 'facility': 'ZA008', 'geoPoint': {'lat': -29.8579, 'lon': 31.0292}}, {'city': 'Port Elizabeth', 'country': 'South Africa', 'facility': 'ZA007', 'geoPoint': {'lat': -33.96109, 'lon': 25.61494}}, {'city': 'Pretoria', 'country': 'South Africa', 'facility': 'ZA001', 'geoPoint': {'lat': -25.74486, 'lon': 28.18783}}, {'city': 'Pretoria', 'country': 'South Africa', 'facility': 'ZA009', 'geoPoint': {'lat': -25.74486, 'lon': 28.18783}}, {'city': 'Falun', 'country': 'Sweden', 'facility': 'SE001', 'geoPoint': {'lat': 60.60357, 'lon': 15.62597}}, {'city': 'Stockholm', 'country': 'Sweden', 'facility': 'SE002', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'city': 'Uppsala', 'country': 'Sweden', 'facility': 'SE003', 'geoPoint': {'lat': 59.85882, 'lon': 17.63889}}], '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'}}}}