Ignite Creation Date:
2025-12-26 @ 1:19 PM
Ignite Modification Date:
2026-02-21 @ 6:44 PM
Study NCT ID:
NCT02933606
Status:
COMPLETED
Last Update Posted:
2023-02-27
First Post:
2016-09-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Phase II Study of BNC210 in 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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'BNC210clinicalstudies@bionomics.com.au', 'phone': '+61 8 8150 7400', 'title': 'VP Clinical Development', 'organization': 'Bionomics Limited'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': "BNC210 suspension that is dependent on concomitant food intake did not achieve expected exposure levels in the trial participants. However, a planned pharmacometrics analysis established a model of CAPS-5 scores versus plasma exposure and predicted a target exposure for future trials (O'Connor S., SOBP Conference Poster, 2019). A new tablet formulation is being evaluated in a second BNC210 Phase 2 PTSD trial (NCT04951076) and substantially higher exposures are expected in the participants."}}, 'adverseEventsModule': {'timeFrame': '15 Weeks', 'eventGroups': [{'id': 'EG000', 'title': 'BNC210 600 mg b.i.d.', 'description': 'Suspension administered orally for 12 weeks.', 'otherNumAtRisk': 48, 'deathsNumAtRisk': 48, 'otherNumAffected': 31, 'seriousNumAtRisk': 48, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'BNC210 300 mg b.i.d.', 'description': 'Suspension administered orally for 12 weeks.', 'otherNumAtRisk': 48, 'deathsNumAtRisk': 48, 'otherNumAffected': 42, 'seriousNumAtRisk': 48, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'BNC210 150 mg b.i.d.', 'description': 'Suspension administered orally for 12 weeks.', 'otherNumAtRisk': 47, 'deathsNumAtRisk': 47, 'otherNumAffected': 30, 'seriousNumAtRisk': 47, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Placebo b.i.d.', 'description': 'Suspension administered orally for 12 weeks.', 'otherNumAtRisk': 49, 'deathsNumAtRisk': 49, 'otherNumAffected': 45, 'seriousNumAtRisk': 49, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 47, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 47, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 9, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dry Mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 47, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 9, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 15, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 47, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 17, 'numAffected': 12}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 7, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 47, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 47, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 5, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Viral Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 47, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 47, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Acute Abdomen', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Elevated Liver Function Tests', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Clinician-Administered PTSD Scale for the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) (CAPS-5), Total Symptom Severity Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'BNC210 600 mg b.i.d.', 'description': 'Suspension administered orally for 12 weeks.'}, {'id': 'OG001', 'title': 'BNC210 300 mg b.i.d.', 'description': 'Suspension administered orally for 12 weeks.'}, {'id': 'OG002', 'title': 'BNC210 150 mg b.i.d.', 'description': 'Suspension administered orally for 12 weeks.'}, {'id': 'OG003', 'title': 'Placebo b.i.d.', 'description': 'Suspension administered orally for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '15.26', 'groupId': 'OG000', 'lowerLimit': '11.2', 'upperLimit': '19.3'}, {'value': '16.62', 'groupId': 'OG001', 'lowerLimit': '12.3', 'upperLimit': '20.9'}, {'value': '19.76', 'groupId': 'OG002', 'lowerLimit': '15.5', 'upperLimit': '24.0'}, {'value': '14.57', 'groupId': 'OG003', 'lowerLimit': '9.8', 'upperLimit': '19.4'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '12 weeks.', 'description': 'Investigator-rated PTSD symptom severity.\n\nThe range for the Clinician-Administered PTSD Scale for the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) (CAPS-5)Total Symptom Severity Score is 0-80, with a higher score meaning a higher severity of disease.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Post-Traumatic Stress Disorder (PTSD) Checklist for the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) (PCL-5).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'BNC210 600 mg b.i.d.', 'description': 'Suspension administered orally for 12 weeks.'}, {'id': 'OG001', 'title': 'BNC210 300 mg b.i.d.', 'description': 'Suspension administered orally for 12 weeks.'}, {'id': 'OG002', 'title': 'BNC210 150 mg b.i.d.', 'description': 'Suspension administered orally for 12 weeks.'}, {'id': 'OG003', 'title': 'Placebo b.i.d.', 'description': 'Suspension administered orally for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '25.02', 'groupId': 'OG000', 'lowerLimit': '19.1', 'upperLimit': '31.0'}, {'value': '20.99', 'groupId': 'OG001', 'lowerLimit': '15.3', 'upperLimit': '26.7'}, {'value': '29.97', 'groupId': 'OG002', 'lowerLimit': '23.5', 'upperLimit': '36.4'}, {'value': '24.65', 'groupId': 'OG003', 'lowerLimit': '17.8', 'upperLimit': '31.5'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '12 weeks.', 'description': 'Self-reported PTSD symptom severity.\n\nThe range for the Post-Traumatic Stress Disorder (PTSD) Checklist for the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) (PCL-5) Symptom Severity Score is 0-80, with a higher score meaning a higher severity of disease.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Montgomery- Åsberg Depression Rating Scale (MADRS).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'BNC210 600 mg b.i.d.', 'description': 'Suspension administered orally for 12 weeks.'}, {'id': 'OG001', 'title': 'BNC210 300 mg b.i.d.', 'description': 'Suspension administered orally for 12 weeks.'}, {'id': 'OG002', 'title': 'BNC210 150 mg b.i.d.', 'description': 'Suspension administered orally for 12 weeks.'}, {'id': 'OG003', 'title': 'Placebo b.i.d.', 'description': 'Suspension administered orally for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.48', 'groupId': 'OG000', 'lowerLimit': '6.7', 'upperLimit': '12.3'}, {'value': '10.25', 'groupId': 'OG001', 'lowerLimit': '7.7', 'upperLimit': '12.8'}, {'value': '12.16', 'groupId': 'OG002', 'lowerLimit': '9.4', 'upperLimit': '14.9'}, {'value': '8.94', 'groupId': 'OG003', 'lowerLimit': '6.1', 'upperLimit': '11.8'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '12 weeks.', 'description': 'Depression severity.\n\nThe range for the Montgomery- Åsberg Depression Rating Scale (MADRS) is 0-60, with a higher score meaning a higher severity of disease.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Hamilton Anxiety Rating Scale (HAM-A).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'BNC210 600 mg b.i.d.', 'description': 'Suspension administered orally for 12 weeks.'}, {'id': 'OG001', 'title': 'BNC210 300 mg b.i.d.', 'description': 'Suspension administered orally for 12 weeks.'}, {'id': 'OG002', 'title': 'BNC210 150 mg b.i.d.', 'description': 'Suspension administered orally for 12 weeks.'}, {'id': 'OG003', 'title': 'Placebo b.i.d.', 'description': 'Suspension administered orally for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.03', 'groupId': 'OG000', 'lowerLimit': '6.6', 'upperLimit': '11.5'}, {'value': '9.94', 'groupId': 'OG001', 'lowerLimit': '7.6', 'upperLimit': '12.3'}, {'value': '10.55', 'groupId': 'OG002', 'lowerLimit': '8.1', 'upperLimit': '13.0'}, {'value': '7.94', 'groupId': 'OG003', 'lowerLimit': '5.3', 'upperLimit': '10.6'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '12 weeks', 'description': 'Anxiety severity.\n\nThe range for the Hamilton Anxiety Rating Scale (HAM-A) is 0-56, with a higher score meaning a higher severity of disease.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Clinical Global Impressions - Severity Scale (CGI-S).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'BNC210 600 mg b.i.d.', 'description': 'Suspension administered orally for 12 weeks.'}, {'id': 'OG001', 'title': 'BNC210 300 mg b.i.d.', 'description': 'Suspension administered orally for 12 weeks.'}, {'id': 'OG002', 'title': 'BNC210 150 mg b.i.d.', 'description': 'Suspension administered orally for 12 weeks.'}, {'id': 'OG003', 'title': 'Placebo b.i.d.', 'description': 'Suspension administered orally for 12 weeks.'}], 'classes': [{'categories': [{'title': 'Normal, not at all ill', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}, {'title': 'Borderline mentally ill', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}, {'title': 'Mildly ill', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}, {'title': 'Moderately ill', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}, {'title': 'Markedly ill', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}, {'title': 'Severely ill', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}, {'title': 'Among the most extremely ill patients', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 weeks', 'description': "Clinician's assessment of global symptom severity using the Clinical Global Impressions - Severity Scale (CGI-S).", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Clinical Global Impressions - Improvement Scale (CGI-I).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'BNC210 600 mg b.i.d.', 'description': 'Suspension administered orally for 12 weeks.'}, {'id': 'OG001', 'title': 'BNC210 300 mg b.i.d.', 'description': 'Suspension administered orally for 12 weeks.'}, {'id': 'OG002', 'title': 'BNC210 150 mg b.i.d.', 'description': 'Suspension administered orally for 12 weeks.'}, {'id': 'OG003', 'title': 'Placebo b.i.d.', 'description': 'Suspension administered orally for 12 weeks.'}], 'classes': [{'categories': [{'title': 'Very Much Improved/Much Improved', 'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}, {'title': 'Other', 'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 weeks', 'description': "Clinician's assessment of global symptom improvement using the Clinical Global Impressions - Improvement Scale (CGI-I).", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Patient Global Impressions - Severity Scale (PGI-S).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'BNC210 600 mg b.i.d.', 'description': 'Suspension administered orally for 12 weeks.'}, {'id': 'OG001', 'title': 'BNC210 300 mg b.i.d.', 'description': 'Suspension administered orally for 12 weeks.'}, {'id': 'OG002', 'title': 'BNC210 150 mg b.i.d.', 'description': 'Suspension administered orally for 12 weeks.'}, {'id': 'OG003', 'title': 'Placebo b.i.d.', 'description': 'Suspension administered orally for 12 weeks.'}], 'classes': [{'categories': [{'title': 'Normal', 'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}, {'title': 'Mild', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}, {'title': 'Moderate', 'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}, {'title': 'Severe', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 weeks.', 'description': 'Self-reported global symptom severity using the Patient Global Impressions - Severity Scale (CGI-S).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Patient Global Impression - Improvement Scale (PGI-I).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'BNC210 600 mg b.i.d.', 'description': 'Suspension administered orally for 12 weeks.'}, {'id': 'OG001', 'title': 'BNC210 300 mg b.i.d.', 'description': 'Suspension administered orally for 12 weeks.'}, {'id': 'OG002', 'title': 'BNC210 150 mg b.i.d.', 'description': 'Suspension administered orally for 12 weeks.'}, {'id': 'OG003', 'title': 'Placebo b.i.d.', 'description': 'Suspension administered orally for 12 weeks.'}], 'classes': [{'categories': [{'title': 'Very Much/Much Improved', 'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}, {'title': 'Other', 'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 weeks.', 'description': 'Self-reported global symptom improvement using the Patient Global Impression - Improvement Scale (PGI-I).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Assessment of Quality of Life (AQoL-8D).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'BNC210 600 mg b.i.d.', 'description': 'Suspension administered orally for 12 weeks.'}, {'id': 'OG001', 'title': 'BNC210 300 mg b.i.d.', 'description': 'Suspension administered orally for 12 weeks.'}, {'id': 'OG002', 'title': 'BNC210 150 mg b.i.d.', 'description': 'Suspension administered orally for 12 weeks.'}, {'id': 'OG003', 'title': 'Placebo b.i.d.', 'description': 'Suspension administered orally for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '77.95', 'groupId': 'OG000', 'lowerLimit': '71.4', 'upperLimit': '84.5'}, {'value': '76.79', 'groupId': 'OG001', 'lowerLimit': '70.3', 'upperLimit': '83.3'}, {'value': '85.47', 'groupId': 'OG002', 'lowerLimit': '78.0', 'upperLimit': '93.0'}, {'value': '81.05', 'groupId': 'OG003', 'lowerLimit': '73.3', 'upperLimit': '88.9'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '12 weeks.', 'description': 'Quality of Life.\n\nThe range for the Assessment of Quality of Life (AQoL-8D) score is 35-176, with a higher score meaning a lower quality of life.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Social Functioning: Sheehan Disability Scale (SDS).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'BNC210 600 mg b.i.d.', 'description': 'Suspension administered orally for 12 weeks.'}, {'id': 'OG001', 'title': 'BNC210 300 mg b.i.d.', 'description': 'Suspension administered orally for 12 weeks.'}, {'id': 'OG002', 'title': 'BNC210 150 mg b.i.d.', 'description': 'Suspension administered orally for 12 weeks.'}, {'id': 'OG003', 'title': 'Placebo b.i.d.', 'description': 'Suspension administered orally for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.84', 'groupId': 'OG000', 'lowerLimit': '6.2', 'upperLimit': '11.5'}, {'value': '6.66', 'groupId': 'OG001', 'lowerLimit': '4.0', 'upperLimit': '9.3'}, {'value': '10.32', 'groupId': 'OG002', 'lowerLimit': '7.5', 'upperLimit': '13.1'}, {'value': '8.47', 'groupId': 'OG003', 'lowerLimit': '5.3', 'upperLimit': '11.7'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '12 weeks.', 'description': 'Social functioning.\n\nThe range for the Total Score on the Sheehan Disability Scale (SDS) is 0-30, with a higher score meaning a higher degree of impairment.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Sleep Monitoring: Pittsburgh Sleep Quality Index (PSQI).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'BNC210 600 mg b.i.d.', 'description': 'Suspension administered orally for 12 weeks.'}, {'id': 'OG001', 'title': 'BNC210 300 mg b.i.d.', 'description': 'Suspension administered orally for 12 weeks.'}, {'id': 'OG002', 'title': 'BNC210 150 mg b.i.d.', 'description': 'Suspension administered orally for 12 weeks.'}, {'id': 'OG003', 'title': 'Placebo b.i.d.', 'description': 'Suspension administered orally for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.80', 'groupId': 'OG000', 'lowerLimit': '7.5', 'upperLimit': '10.1'}, {'value': '8.83', 'groupId': 'OG001', 'lowerLimit': '7.6', 'upperLimit': '10.1'}, {'value': '9.15', 'groupId': 'OG002', 'lowerLimit': '7.7', 'upperLimit': '10.6'}, {'value': '8.00', 'groupId': 'OG003', 'lowerLimit': '6.4', 'upperLimit': '9.6'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '12 weeks.', 'description': 'Sleep quality and duration.\n\nThe range for the Pittsburgh Sleep Quality Index (PSQI) score is 0-21, with a higher score meaning a worse level of sleep quality', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'CANTAB (Cambridge Neuropsychological Test Automated Battery) Cognitive Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'BNC210 600 mg b.i.d.', 'description': 'Suspension administered orally for 12 weeks.'}, {'id': 'OG001', 'title': 'BNC210 300 mg b.i.d.', 'description': 'Suspension administered orally for 12 weeks.'}, {'id': 'OG002', 'title': 'BNC210 150 mg b.i.d.', 'description': 'Suspension administered orally for 12 weeks.'}, {'id': 'OG003', 'title': 'Placebo b.i.d.', 'description': 'Suspension administered orally for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.06', 'groupId': 'OG000', 'lowerLimit': '-0.1', 'upperLimit': '0.2'}, {'value': '0.12', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '0.2'}, {'value': '0.18', 'groupId': 'OG002', 'lowerLimit': '0.1', 'upperLimit': '0.3'}, {'value': '0.02', 'groupId': 'OG003', 'lowerLimit': '-0.1', 'upperLimit': '0.2'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '12 Weeks', 'description': "The CANTAB global composite score is based on the Z scores for CANTAB outcome measures (PAL first attempt memory score (PALFAMS), PAL total errors adjusted (PALTEA), SWM between errors (SWMBE), SWM strategy (SWMS), RVP A' prime (RVPA), RVP median latency (RVPMDL). Specifically, the global composite score of cognitive function is as follows: CANTAB global composite score of cognitive function = (ZPALFAMS + ZPALTEA + ZSWMBE + ZSWMS + ZRVPA + ZRVPMDL) /8 (higher is better)\n\nA Z-score of 0 represents the population mean. A Z-score above 0 indicates cognition higher than the population mean and Z-score below 0 indicates cognition lower than the population mean", 'unitOfMeasure': 'Composite Z score', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'BNC210 600 mg b.i.d.', 'description': 'Suspension administered orally for 12 weeks.'}, {'id': 'FG001', 'title': 'BNC210 300 mg b.i.d.', 'description': 'Suspension administered orally for 12 weeks.'}, {'id': 'FG002', 'title': 'BNC210 150 mg b.i.d.', 'description': 'Suspension administered orally for 12 weeks.'}, {'id': 'FG003', 'title': 'Placebo b.i.d.', 'description': 'Suspension administered orally for 12 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '49'}, {'groupId': 'FG001', 'numSubjects': '48'}, {'groupId': 'FG002', 'numSubjects': '47'}, {'groupId': 'FG003', 'numSubjects': '49'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '39'}, {'groupId': 'FG002', 'numSubjects': '33'}, {'groupId': 'FG003', 'numSubjects': '30'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '14'}, {'groupId': 'FG003', 'numSubjects': '19'}]}]}], 'preAssignmentDetails': '193 participants were enrolled into the study and randomized to one of the 4 treatment arms. However, 1 participant withdrew from the study prior to beginning treatment with study IP and hence is not included in the overall number of 192 participants who received study IP and for which post-baseline assessments were performed.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}, {'value': '49', 'groupId': 'BG003'}, {'value': '192', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'BNC210 600 mg b.i.d.', 'description': 'Suspension administered orally for 12 weeks.'}, {'id': 'BG001', 'title': 'BNC210 300 mg b.i.d.', 'description': 'Suspension administered orally for 12 weeks.'}, {'id': 'BG002', 'title': 'BNC210 150 mg b.i.d.', 'description': 'Suspension administered orally for 12 weeks.'}, {'id': 'BG003', 'title': 'Placebo b.i.d.', 'description': 'Suspension administered orally for 12 weeks.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}, {'value': '49', 'groupId': 'BG003'}, {'value': '189', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}, {'value': '112', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}, {'value': '80', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '45', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}, {'value': '34', 'groupId': 'BG003'}, {'value': '135', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}, {'value': '38', 'groupId': 'BG003'}, {'value': '161', 'groupId': 'BG004'}]}]}, {'title': 'Australia', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '31', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-05-30', 'size': 1320838, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-12-15T00:58', 'hasProtocol': True}, {'date': '2018-09-27', 'size': 680014, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-12-15T01:00', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Double blind'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 193}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'dispFirstSubmitDate': '2020-03-05', 'completionDateStruct': {'date': '2018-07-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-23', 'studyFirstSubmitDate': '2016-09-01', 'dispFirstSubmitQcDate': '2020-03-05', 'resultsFirstSubmitDate': '2022-07-19', 'studyFirstSubmitQcDate': '2016-10-13', 'dispFirstPostDateStruct': {'date': '2020-03-10', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2023-02-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-02-23', 'studyFirstPostDateStruct': {'date': '2016-10-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinician-Administered PTSD Scale for the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) (CAPS-5), Total Symptom Severity Score', 'timeFrame': '12 weeks.', 'description': 'Investigator-rated PTSD symptom severity.\n\nThe range for the Clinician-Administered PTSD Scale for the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) (CAPS-5)Total Symptom Severity Score is 0-80, with a higher score meaning a higher severity of disease.'}], 'secondaryOutcomes': [{'measure': 'Post-Traumatic Stress Disorder (PTSD) Checklist for the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) (PCL-5).', 'timeFrame': '12 weeks.', 'description': 'Self-reported PTSD symptom severity.\n\nThe range for the Post-Traumatic Stress Disorder (PTSD) Checklist for the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) (PCL-5) Symptom Severity Score is 0-80, with a higher score meaning a higher severity of disease.'}, {'measure': 'Montgomery- Åsberg Depression Rating Scale (MADRS).', 'timeFrame': '12 weeks.', 'description': 'Depression severity.\n\nThe range for the Montgomery- Åsberg Depression Rating Scale (MADRS) is 0-60, with a higher score meaning a higher severity of disease.'}, {'measure': 'Hamilton Anxiety Rating Scale (HAM-A).', 'timeFrame': '12 weeks', 'description': 'Anxiety severity.\n\nThe range for the Hamilton Anxiety Rating Scale (HAM-A) is 0-56, with a higher score meaning a higher severity of disease.'}, {'measure': 'Clinical Global Impressions - Severity Scale (CGI-S).', 'timeFrame': '12 weeks', 'description': "Clinician's assessment of global symptom severity using the Clinical Global Impressions - Severity Scale (CGI-S)."}, {'measure': 'Clinical Global Impressions - Improvement Scale (CGI-I).', 'timeFrame': '12 weeks', 'description': "Clinician's assessment of global symptom improvement using the Clinical Global Impressions - Improvement Scale (CGI-I)."}, {'measure': 'Patient Global Impressions - Severity Scale (PGI-S).', 'timeFrame': '12 weeks.', 'description': 'Self-reported global symptom severity using the Patient Global Impressions - Severity Scale (CGI-S).'}, {'measure': 'Patient Global Impression - Improvement Scale (PGI-I).', 'timeFrame': '12 weeks.', 'description': 'Self-reported global symptom improvement using the Patient Global Impression - Improvement Scale (PGI-I).'}, {'measure': 'Assessment of Quality of Life (AQoL-8D).', 'timeFrame': '12 weeks.', 'description': 'Quality of Life.\n\nThe range for the Assessment of Quality of Life (AQoL-8D) score is 35-176, with a higher score meaning a lower quality of life.'}, {'measure': 'Social Functioning: Sheehan Disability Scale (SDS).', 'timeFrame': '12 weeks.', 'description': 'Social functioning.\n\nThe range for the Total Score on the Sheehan Disability Scale (SDS) is 0-30, with a higher score meaning a higher degree of impairment.'}, {'measure': 'Sleep Monitoring: Pittsburgh Sleep Quality Index (PSQI).', 'timeFrame': '12 weeks.', 'description': 'Sleep quality and duration.\n\nThe range for the Pittsburgh Sleep Quality Index (PSQI) score is 0-21, with a higher score meaning a worse level of sleep quality'}, {'measure': 'CANTAB (Cambridge Neuropsychological Test Automated Battery) Cognitive Assessment', 'timeFrame': '12 Weeks', 'description': "The CANTAB global composite score is based on the Z scores for CANTAB outcome measures (PAL first attempt memory score (PALFAMS), PAL total errors adjusted (PALTEA), SWM between errors (SWMBE), SWM strategy (SWMS), RVP A' prime (RVPA), RVP median latency (RVPMDL). Specifically, the global composite score of cognitive function is as follows: CANTAB global composite score of cognitive function = (ZPALFAMS + ZPALTEA + ZSWMBE + ZSWMS + ZRVPA + ZRVPMDL) /8 (higher is better)\n\nA Z-score of 0 represents the population mean. A Z-score above 0 indicates cognition higher than the population mean and Z-score below 0 indicates cognition lower than the population mean"}]}, 'oversightModule': {'isFdaRegulatedDrug': True}, 'conditionsModule': {'conditions': ['Post-Traumatic Stress Disorder']}, 'descriptionModule': {'briefSummary': 'This is a randomized, double-blind, placebo-controlled study, evaluating the effects of BNC210 versus placebo on the symptoms of Post-Traumatic Stress Disorder, as measured by the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5).\n\nThe secondary objectives of the study are to evaluate the effects of BNC210 on anxiety, depression, global functioning and patient reported outcomes in patients with PTSD. Safety and tolerability of BNC210 will also be assessed. Study participants will receive 12 weeks of blinded treatment followed by a 3 week follow-up period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Signed and dated informed consent.\n* Male or female between 18 and 70 years of age, inclusive.\n* Diagnosed with current PTSD as defined by the CAPS-5 for DSM-5.\n* Currently not using any psychiatric medications except for:\n\n * No more than one selective serotonin reuptake inhibitor (SSRI) (fluvoxamine is excluded) or serotonin noradrenaline reuptake inhibitor (SNRI) within the licensed prescribing dose range. Subjects must have been on a stable dose for at least 3 months prior and through Screening, with the intent to remain on the same dose through to Week 16.\n * As needed (PRN) use of benzodiazepines (BZD) at a frequency not exceeding 2 days per week in the 3 months prior to Screening. The total dose must not exceed 30 mg/day in diazepam equivalents.\n* Subjects not currently receiving psychotherapy except long term supportive counseling or subjects that have received intensive regular psychotherapy for a minimum of three months prior to Screening.\n* Females of childbearing potential must have a negative serum pregnancy. Females not of childbearing potential must be postmenopausal. Sterilized male patients must be at least 1 year post-vasectomy to be considered of non-child bearing potential. Females and males of childbearing potential must agree to use two effective methods of contraception.\n\nKey Exclusion Criteria\n\n* Current and ongoing exposure to the trauma that caused the PTSD.\n* Failed more than three trials of antidepressant medication(s) prescribed for the treatment of PTSD. Each trial must have lasted at least 6 weeks to be considered a failed attempt. A trial that was terminated due to intolerability or side effects does not constitute a failed attempt.\n* The use of psychiatric medications within 2 weeks of Screening except for SSRIs, SNRIs or limited PRN BZD use as per inclusion criterion 4. Restricted psychiatric medications include (but are not limited to) antidepressants not allowed by inclusion criterion 4, antianxiety drugs (except limited BZD use per inclusion criterion 4), mood stabilizers, stimulants, antipsychotics, hypnotics and acetylcholinesterase inhibitors.\n* History of significant traumatic brain injury.\n* Depression as measured by Montgomery-Äsberg depression scale (MADRS) rating \\> 23.\n* Bipolar and psychotic disorders as identified at Screening using the MINI International Neuropsychiatry Interview (V7.0) (M.I.N.I).\n* A score ≥ 7 on the McLean Screening Instrument for Borderline Personality Disorder (MSI-BPD) at Screening.\n* History of seizure disorders, uncontrolled sleep apnoea or severe neurologic disease.\n* Increased risk of suicide, defined as:\n\n * Any previous suicide attempt disclosed by the participant at Screening using the Columbia Suicide Severity Rating Scale (C-SSRS).\n * Any suicidal ideation with intent (yes to item 4 and / or 5) or suicidal behavior in the past year, as captured at Screening using the C-SSRS.\n * A score \\> 4 on item 10 of the MADRS at Screening.\n* The use of alprazolam or flunitrazepam within 3 months of Screening.\n* Any clinically significant abnormalities in laboratory test results, vitals signs, or ECG at Screening.\n* Positive result for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C (HCV) at Screening.\n* Any moderate to severe substance use disorder (any type) in the 12 months prior to Screening as identified by the DSM-5 using the M.I.N.I (V7.0).\n* Current Australian serving Defense personnel or any member of the US military currently serving on active duty.\n* Participants involved with ongoing insurance or workplace claims that in the opinion of the Investigator are likely to have an impact on the mental health, presentation or capacity of the patient to engage in the study.'}, 'identificationModule': {'nctId': 'NCT02933606', 'acronym': 'RESTORE', 'briefTitle': 'Phase II Study of BNC210 in PTSD', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bionomics Limited'}, 'officialTitle': 'A Randomized, Double-blind, Placebo-controlled Phase II Study of BNC210 in Adults With Post-Traumatic Stress Disorder (PTSD).', 'orgStudyIdInfo': {'id': 'BNC210.007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BNC210 600 mg b.i.d.', 'description': 'Suspension administered orally for 12 weeks.', 'interventionNames': ['Drug: BNC210']}, {'type': 'EXPERIMENTAL', 'label': 'BNC210 300 mg b.i.d.', 'description': 'Suspension administered orally for 12 weeks.', 'interventionNames': ['Drug: BNC210']}, {'type': 'EXPERIMENTAL', 'label': 'BNC210 150 mg b.i.d.', 'description': 'Suspension administered orally for 12 weeks.', 'interventionNames': ['Drug: BNC210']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo b.i.d.', 'description': 'Suspension administered orally for 12 weeks.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'BNC210', 'type': 'DRUG', 'armGroupLabels': ['BNC210 150 mg b.i.d.', 'BNC210 300 mg b.i.d.', 'BNC210 600 mg b.i.d.']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo b.i.d.']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92056', 'city': 'Oceanside', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.19587, 'lon': -117.37948}}, {'zip': '92270', 'city': 'Rancho Mirage', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.73974, 'lon': -116.41279}}, {'zip': '92374', 'city': 'Redlands', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.05557, 'lon': -117.18254}}, {'zip': '92506', 'city': 'Riverside', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.95335, 'lon': -117.39616}}, {'zip': '32607', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '32256', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '33309', 'city': 'Lauderhill', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 26.14036, 'lon': -80.21338}}, {'zip': '33161', 'city': 'North Miami', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 25.89009, 'lon': -80.18671}}, {'zip': '33334', 'city': 'Oakland Park', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 26.17231, 'lon': -80.13199}}, {'zip': '32801', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '60169', 'city': 'Hoffman Estates', 'state': 'Illinois', 'country': 'United States', 'geoPoint': {'lat': 42.04281, 'lon': -88.0798}}, {'zip': '66211', 'city': 'Overland Park', 'state': 'Kansas', 'country': 'United States', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}, {'zip': '02740', 'city': 'New Bedford', 'state': 'Massachusetts', 'country': 'United States', 'geoPoint': {'lat': 41.63526, 'lon': -70.92701}}, {'zip': '68526', 'city': 'Lincoln', 'state': 'Nebraska', 'country': 'United States', 'geoPoint': {'lat': 40.8, 'lon': -96.66696}}, {'zip': '89102', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '08009', 'city': 'Berlin', 'state': 'New Jersey', 'country': 'United States', 'geoPoint': {'lat': 39.79123, 'lon': -74.92905}}, {'zip': '44718', 'city': 'Canton', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 40.79895, 'lon': -81.37845}}, {'zip': '38119', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '75231', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '2751', 'city': 'Penrith', 'state': 'New South Wales', 'country': 'Australia', 'geoPoint': {'lat': -33.75, 'lon': 150.7}}, {'zip': '4066', 'city': 'Auchenflower', 'state': 'Queensland', 'country': 'Australia', 'geoPoint': {'lat': -27.47443, 'lon': 152.99213}}, {'zip': '4066', 'city': 'Toowong', 'state': 'Queensland', 'country': 'Australia', 'geoPoint': {'lat': -27.48333, 'lon': 152.98333}}, {'zip': '5112', 'city': 'Elizabeth Vale', 'state': 'South Australia', 'country': 'Australia', 'geoPoint': {'lat': -34.74857, 'lon': 138.66819}}, {'zip': '3004', 'city': 'St Kilda', 'state': 'Victoria', 'country': 'Australia', 'geoPoint': {'lat': -37.8676, 'lon': 144.98099}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bionomics Limited', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}