Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2025-12-27 @ 11:10 PM
Study NCT ID:
NCT04855760
Status:
COMPLETED
Last Update Posted:
2025-02-11
First Post:
2021-04-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety of REL-1017 for Major Depressive Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003865', 'term': 'Depressive Disorder, Major'}], 'ancestors': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'info@relmada.com', 'phone': '786-638-7384', 'title': 'Marco Pappagallo, MD', 'organization': 'Relmada Therapeutics'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'A Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) that starts or worsens at any time after initiation of study drug collected up to 1 month post treatment (Day 395) as collected in the Safety Analysis Set.', 'description': 'A TEAE is defined as an AE that starts or worsens at any time after initiation of study drug collected up to 1 month post treatment (Day 395) as collected in the Safety Analysis Set.', 'eventGroups': [{'id': 'EG000', 'title': 'REL-1017', 'description': 'Total participants in Open Label Study\n\nREL-1017: REL-1017 tablet', 'otherNumAtRisk': 624, 'deathsNumAtRisk': 624, 'otherNumAffected': 142, 'seriousNumAtRisk': 624, 'deathsNumAffected': 0, 'seriousNumAffected': 8}], 'otherEvents': [{'term': 'COVID-19', 'notes': 'Not related to study drug.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 624, 'numEvents': 62, 'numAffected': 60}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 624, 'numEvents': 77, 'numAffected': 61}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Upper respiratory tract infections', 'notes': 'Not related to study drug.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 624, 'numEvents': 67, 'numAffected': 53}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}], 'seriousEvents': [{'term': 'Coronary artery disease', 'notes': 'Not related to study drug.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 624, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Tachycardia', 'notes': 'Not related to study drug.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 624, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Alcohol abuse', 'notes': 'Not related to study drug.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 624, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Anxiety', 'notes': 'Not related to study drug.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 624, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Anaphylactic reaction', 'notes': 'Not related to study drug.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 624, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Bacteraemia', 'notes': 'Not related to study drug.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 624, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pyelonephritis', 'notes': 'Not related to study drug.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 624, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hyperglycaemia', 'notes': 'Not related to study drug.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 624, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hyperreflexia', 'notes': 'Not related to study drug.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 624, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Tremor', 'notes': 'Not related to study drug.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 624, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Sepsis', 'notes': 'Not related to study drug.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 624, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Safety and Tolerability of REL-1017 as Incidence of Treatment Emergent Adverse Events (TEAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '624', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'REL-1017', 'description': 'Total participants in Open Label Study\n\nREL-1017: REL-1017 tablet'}], 'classes': [{'categories': [{'measurements': [{'value': '350', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '52 weeks', 'description': 'Subjects with at least one Treatment Emergent Adverse Events (TEAEs)', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set: All participants who received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': "Change in the QT Interval With Fridericia's Correction (QTcF) Interval From Baseline to Month 3", 'denoms': [{'units': 'Participants', 'counts': [{'value': '534', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'REL-1017', 'description': 'Total participants in Open Label Study\n\nREL-1017: REL-1017 tablet'}], 'classes': [{'categories': [{'measurements': [{'value': '4.11', 'spread': '14.54', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 Month', 'description': "Cardiac Safety of REL-1017 as measured by the Change in the QT interval with Fridericia's correction (QTcF) Interval From Baseline to Month 3.\n\nA negative change from baseline indicates shortening of the QTcF.", 'unitOfMeasure': 'ms', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set: All participants who received at least 1 dose of study drug and were assessed for the secondary safety endpoint at both Baseline and Month 3.'}, {'type': 'SECONDARY', 'title': "Change in the QT Interval With Fridericia's Correction (QTcF) Interval From Baseline to Month 6", 'denoms': [{'units': 'Participants', 'counts': [{'value': '435', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'REL-1017', 'description': 'Total participants in Open Label Study\n\nREL-1017: REL-1017 tablet'}], 'classes': [{'categories': [{'measurements': [{'value': '2.70', 'spread': '15.26', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 Month', 'description': "Cardiac Safety of REL-1017 as measured by the Change in the QT interval with Fridericia's correction (QTcF) Interval From Baseline to Month 6.\n\nA negative change from baseline indicates shortening of the QTcF.", 'unitOfMeasure': 'ms', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set: All participants who received at least 1 dose of study drug and were assessed for the secondary safety endpoint at both Baseline and Month 6.'}, {'type': 'SECONDARY', 'title': "Change in the QT Interval With Fridericia's Correction (QTcF) Interval From Baseline to Month 12", 'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'REL-1017', 'description': 'Total participants in Open Label Study\n\nREL-1017: REL-1017 tablet'}], 'classes': [{'categories': [{'measurements': [{'value': '2.59', 'spread': '13.77', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 Month', 'description': "Cardiac Safety of REL-1017 as measured by the Change in the QT interval with Fridericia's correction (QTcF) Interval From Baseline to Month 12.\n\nA negative change from baseline indicates shortening of the QTcF.", 'unitOfMeasure': 'ms', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set: All participants who received at least 1 dose of study drug and were assessed for the secondary safety endpoint at both Baseline and Month 12.'}, {'type': 'SECONDARY', 'title': 'Change in Diastolic Blood Pressure From Baseline to Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '505', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'REL-1017', 'description': 'Total participants in Open Label Study\n\nREL-1017: REL-1017 tablet'}], 'classes': [{'categories': [{'measurements': [{'value': '0.5', 'spread': '7.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 Month', 'description': 'Cardiac Safety of REL-1017 as measured by the Diastolic Blood Pressure (Supine/Semi-Supine) From Baseline to Month 3.\n\nA negative change from baseline indicates a reduction in Diastolic Blood Pressure.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set: All participants who received at least 1 dose of study drug and were assessed for the secondary safety endpoint at both Baseline and Month 3.'}, {'type': 'SECONDARY', 'title': 'Change in Diastolic Blood Pressure From Baseline to Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'REL-1017', 'description': 'Total participants in Open Label Study\n\nREL-1017: REL-1017 tablet'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.2', 'spread': '8.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 Month', 'description': 'Cardiac Safety of REL-1017 as measured by the Diastolic Blood Pressure (Supine/Semi-Supine) From Baseline to Month 12.\n\nA negative change from baseline indicates a reduction in Diastolic Blood Pressure.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set: All participants who received at least 1 dose of study drug and were assessed for the secondary safety endpoint at both Baseline and Month 12.'}, {'type': 'SECONDARY', 'title': 'Change in Systolic Blood Pressure From Baseline to Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '505', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'REL-1017', 'description': 'Total participants in Open Label Study\n\nREL-1017: REL-1017 tablet'}], 'classes': [{'categories': [{'measurements': [{'value': '0.4', 'spread': '9.9', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 Month', 'description': 'Cardiac Safety of REL-1017 as measured by the Systolic Blood Pressure (Supine/Semi-Supine) From Baseline to Month 3.\n\nA negative change from baseline indicates a reduction in Systolic Blood Pressure.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set: All participants who received at least 1 dose of study drug and were assessed for the secondary safety endpoint at both Baseline and Month 3.'}, {'type': 'SECONDARY', 'title': 'Change in Systolic Blood Pressure From Baseline to Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'REL-1017', 'description': 'Total participants in Open Label Study\n\nREL-1017: REL-1017 tablet'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'spread': '10.9', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 Month', 'description': 'Cardiac Safety of REL-1017 as measured by the Systolic Blood Pressure (Supine/Semi-Supine) From Baseline to Month 12.\n\nA negative change from baseline indicates a reduction in Systolic Blood Pressure.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set: All participants who received at least 1 dose of study drug and were assessed for the secondary safety endpoint at both Baseline and Month 12.'}, {'type': 'SECONDARY', 'title': 'Change in Heart Rate From Baseline to Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '505', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'REL-1017', 'description': 'Total participants in Open Label Study\n\nREL-1017: REL-1017 tablet'}], 'classes': [{'categories': [{'measurements': [{'value': '0.8', 'spread': '9.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 Month', 'description': 'Cardiac Safety of REL-1017 as measured by the Heart Rate (Supine/Semi-Supine) From Baseline to Month 3.\n\nA negative change from baseline indicates a reduction in Heart Rate.', 'unitOfMeasure': 'beats/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set: All participants who received at least 1 dose of study drug and were assessed for the secondary safety endpoint at both Baseline and Month 3.'}, {'type': 'SECONDARY', 'title': 'Change in Heart Rate From Baseline to Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'REL-1017', 'description': 'Total participants in Open Label Study\n\nREL-1017: REL-1017 tablet'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.1', 'spread': '9.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 Month', 'description': 'Cardiac Safety of REL-1017 as measured by the Heart Rate (Supine/Semi-Supine) From Baseline to Month 12.\n\nA negative change from baseline indicates a reduction in Heart Rate.', 'unitOfMeasure': 'beats/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set: All participants who received at least 1 dose of study drug and were assessed for the secondary safety endpoint at both Baseline and Month 12.'}, {'type': 'SECONDARY', 'title': 'Change in Weight From Baseline to Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '545', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'REL-1017', 'description': 'Total participants in Open Label Study\n\nREL-1017: REL-1017 tablet'}], 'classes': [{'categories': [{'measurements': [{'value': '0.32', 'spread': '4.45', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 Month', 'description': 'Overall Safety of REL-1017 as measured by Weight From Baseline to Month 3.\n\nA negative change from baseline indicates a reduction in Weight.', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set: All participants who received at least 1 dose of study drug and were assessed for the secondary safety endpoint at both Baseline and Month 3.'}, {'type': 'SECONDARY', 'title': 'Change in Weight From Baseline to Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'REL-1017', 'description': 'Total participants in Open Label Study\n\nREL-1017: REL-1017 tablet'}], 'classes': [{'categories': [{'measurements': [{'value': '0.33', 'spread': '5.56', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 Month', 'description': 'Overall Safety of REL-1017 as measured by Weight From Baseline to Month 12.\n\nA negative change from baseline indicates a reduction in Weight.', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set: All participants who received at least 1 dose of study drug and were assessed for the secondary safety endpoint at both Baseline and Month 12.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in the MADRS10 Total Score From Baseline to Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '536', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'REL-1017', 'description': 'Total participants in Open Label Study\n\nREL-1017: REL-1017 tablet'}], 'classes': [{'categories': [{'measurements': [{'value': '-20.1', 'spread': '10.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 Month', 'description': 'Therapeutic efficacy of REL-1017 in the Montgomery-Asberg Depression Rating Scale (MADRS10) A higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60 with scores above 34 indicating severe depression.\n\nA negative change from baseline indicates improvement.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) at Month 3: All participants who received at least 1 dose of study drug and had at least one post-Baseline efficacy assessment, irrespective of any deviation from the protocol or premature discontinuation at Month 3.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in the MADRS10 Total Score From Baseline to Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'REL-1017', 'description': 'Total participants in Open Label Study\n\nREL-1017: REL-1017 tablet'}], 'classes': [{'categories': [{'measurements': [{'value': '-21.6', 'spread': '10.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 Month', 'description': 'Therapeutic efficacy of REL-1017 in the Montgomery-Asberg Depression Rating Scale (MADRS10) A higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60 with scores above 34 indicating severe depression.\n\nA negative change from baseline indicates improvement.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) at Month 12: All participants who received at least 1 dose of study drug and had at least one post-Baseline efficacy assessment, irrespective of any deviation from the protocol or premature discontinuation at Month 12.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'REL-1017', 'description': 'Roll-over participants received 25 mg REL-1017 (one 25 mg REL-1017 tablet), orally, per day, either as a monotherapy or in addition to their ongoing antidepressant (ADT), rolling over from the monotherapy study REL-1017-303 or the adjunctive therapy studies REL-1017-301 and REL-1017-302, respectively.\n\nDe Novo participants received a 75 mg REL-1017 loading dose (three 25 mg REL-1017 tablets) on Day-1 of the 365-day treatment period. From Day-2 to Day-365, participants received 25 mg REL-1017 either as monotherapy or as adjunctive therapy.\n\nREL-1017: REL-1017 tablet'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '627'}]}, {'type': 'Dosed', 'achievements': [{'groupId': 'FG000', 'numSubjects': '624'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '182'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '445'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '21'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '116'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '21'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '49'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Non-Compliance with Study Drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}]}, {'type': 'Non-Compliance with Study Schedule', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Study Completed by Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '202'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '624', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'REL-1017', 'description': 'Total participants in Open Label Study, including:\n\nRoll-over participants, rolling over from the monotherapy study REL-1017-303 or the adjunctive therapy studies REL-1017-301 and REL-1017-302, respectively.\n\nDe Novo participants receiving REL1017 as either monotherapy or as adjunctive therapy.\n\nREL-1017: REL-1017 tablet'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '42.9', 'spread': '13.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '433', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '191', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '162', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '442', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '24', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '95', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '474', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Safety Analysis Set: All participants who received at least 1 dose of study drug.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-03-04', 'size': 588412, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-04-17T15:01', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 627}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'nctId': 'NCT06009003', 'statusForNctId': 'TEMPORARILY_NOT_AVAILABLE', 'hasExpandedAccess': True}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2023-07-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-22', 'studyFirstSubmitDate': '2021-04-19', 'resultsFirstSubmitDate': '2024-07-16', 'studyFirstSubmitQcDate': '2021-04-19', 'lastUpdatePostDateStruct': {'date': '2025-02-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-07-16', 'studyFirstPostDateStruct': {'date': '2021-04-22', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-08-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in the MADRS10 Total Score From Baseline to Month 3', 'timeFrame': '3 Month', 'description': 'Therapeutic efficacy of REL-1017 in the Montgomery-Asberg Depression Rating Scale (MADRS10) A higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60 with scores above 34 indicating severe depression.\n\nA negative change from baseline indicates improvement.'}, {'measure': 'Change in the MADRS10 Total Score From Baseline to Month 12', 'timeFrame': '12 Month', 'description': 'Therapeutic efficacy of REL-1017 in the Montgomery-Asberg Depression Rating Scale (MADRS10) A higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60 with scores above 34 indicating severe depression.\n\nA negative change from baseline indicates improvement.'}], 'primaryOutcomes': [{'measure': 'Safety and Tolerability of REL-1017 as Incidence of Treatment Emergent Adverse Events (TEAEs)', 'timeFrame': '52 weeks', 'description': 'Subjects with at least one Treatment Emergent Adverse Events (TEAEs)'}], 'secondaryOutcomes': [{'measure': "Change in the QT Interval With Fridericia's Correction (QTcF) Interval From Baseline to Month 3", 'timeFrame': '3 Month', 'description': "Cardiac Safety of REL-1017 as measured by the Change in the QT interval with Fridericia's correction (QTcF) Interval From Baseline to Month 3.\n\nA negative change from baseline indicates shortening of the QTcF."}, {'measure': "Change in the QT Interval With Fridericia's Correction (QTcF) Interval From Baseline to Month 6", 'timeFrame': '6 Month', 'description': "Cardiac Safety of REL-1017 as measured by the Change in the QT interval with Fridericia's correction (QTcF) Interval From Baseline to Month 6.\n\nA negative change from baseline indicates shortening of the QTcF."}, {'measure': "Change in the QT Interval With Fridericia's Correction (QTcF) Interval From Baseline to Month 12", 'timeFrame': '12 Month', 'description': "Cardiac Safety of REL-1017 as measured by the Change in the QT interval with Fridericia's correction (QTcF) Interval From Baseline to Month 12.\n\nA negative change from baseline indicates shortening of the QTcF."}, {'measure': 'Change in Diastolic Blood Pressure From Baseline to Month 3', 'timeFrame': '3 Month', 'description': 'Cardiac Safety of REL-1017 as measured by the Diastolic Blood Pressure (Supine/Semi-Supine) From Baseline to Month 3.\n\nA negative change from baseline indicates a reduction in Diastolic Blood Pressure.'}, {'measure': 'Change in Diastolic Blood Pressure From Baseline to Month 12', 'timeFrame': '12 Month', 'description': 'Cardiac Safety of REL-1017 as measured by the Diastolic Blood Pressure (Supine/Semi-Supine) From Baseline to Month 12.\n\nA negative change from baseline indicates a reduction in Diastolic Blood Pressure.'}, {'measure': 'Change in Systolic Blood Pressure From Baseline to Month 3', 'timeFrame': '3 Month', 'description': 'Cardiac Safety of REL-1017 as measured by the Systolic Blood Pressure (Supine/Semi-Supine) From Baseline to Month 3.\n\nA negative change from baseline indicates a reduction in Systolic Blood Pressure.'}, {'measure': 'Change in Systolic Blood Pressure From Baseline to Month 12', 'timeFrame': '12 Month', 'description': 'Cardiac Safety of REL-1017 as measured by the Systolic Blood Pressure (Supine/Semi-Supine) From Baseline to Month 12.\n\nA negative change from baseline indicates a reduction in Systolic Blood Pressure.'}, {'measure': 'Change in Heart Rate From Baseline to Month 3', 'timeFrame': '3 Month', 'description': 'Cardiac Safety of REL-1017 as measured by the Heart Rate (Supine/Semi-Supine) From Baseline to Month 3.\n\nA negative change from baseline indicates a reduction in Heart Rate.'}, {'measure': 'Change in Heart Rate From Baseline to Month 12', 'timeFrame': '12 Month', 'description': 'Cardiac Safety of REL-1017 as measured by the Heart Rate (Supine/Semi-Supine) From Baseline to Month 12.\n\nA negative change from baseline indicates a reduction in Heart Rate.'}, {'measure': 'Change in Weight From Baseline to Month 3', 'timeFrame': '3 Month', 'description': 'Overall Safety of REL-1017 as measured by Weight From Baseline to Month 3.\n\nA negative change from baseline indicates a reduction in Weight.'}, {'measure': 'Change in Weight From Baseline to Month 12', 'timeFrame': '12 Month', 'description': 'Overall Safety of REL-1017 as measured by Weight From Baseline to Month 12.\n\nA negative change from baseline indicates a reduction in Weight.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['REL-1017'], 'conditions': ['Major Depressive Disorder']}, 'referencesModule': {'references': [{'pmid': '39999772', 'type': 'DERIVED', 'citation': 'Fava M, Pani L, De Martin S, Cutler AJ, Gorodetzky CW, Vocci FJ, Sapienza FL, Kosten TR, Kroger C, Champasa P, Guidetti C, Comai S, Mattarei A, Folli F, Bushnell D, Traversa S, Inturrisi CE, Manfredi PL, Pappagallo M. Long-Term Safety and Efficacy of Esmethadone in Patients With Major Depressive Disorder: Findings From a 12-Month Open-Label Study. J Clin Psychiatry. 2025 Feb 17;86(1):24m15438. doi: 10.4088/JCP.24m15438.'}]}, 'descriptionModule': {'briefSummary': 'This was a 1-year, multicenter, open-label, long-term study to assess the safety of REL-1017 once daily (QD) as monotherapy or as adjunctive treatment of Major Depressive Disorder. Adjunctive study participants continued to take their current antidepressant therapy in addition to the study drug for the duration of the treatment period.', 'detailedDescription': 'This was a multicenter, open-label, long-term study of REL-1017 to evaluate the long-term safety and long-term durability of response in patients with MDD. Patients who completed previous randomized, double-blind Phase 3 trials (NCT04688164, NCT04855747, NCT05081167) of REL-1017 as adjunctive therapy or monotherapy for MDD were asked to continue treatment with REL-1017 25 mg daily for up to 1 year. De novo patients who satisfied inclusion/exclusion criteria also were enrolled and received a 75 mg loading dose of REL-1017 on Day 1 followed by a maintenance dose of 25 mg REL-1017 daily for the remainder of the study (Days 2-365). When REL-1017 was administered as adjunctive treatment, patients continued to use a stable dosage of their concomitant antidepressants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adults 18 to 65 years, inclusive.\n* Diagnosed with Major Depressive Disorder (MDD) based on Structured Clinical Interview for DSM-5 (SCID-5) for MDD.\n* Current major depressive episode.\n\nExclusion Criteria:\n\n* Any current and primary psychiatric disorder other than Major Depressive Disorder.\n* History of bipolar I and II disorder, psychosis, and/or mania.\n* Acute or chronic condition that, in the Investigator's opinion, would limit the subject's ability to complete or participate in this clinical study."}, 'identificationModule': {'nctId': 'NCT04855760', 'acronym': 'RELIANCE-OLS', 'briefTitle': 'Safety of REL-1017 for Major Depressive Disorder', 'organization': {'class': 'INDUSTRY', 'fullName': 'Relmada Therapeutics, Inc.'}, 'officialTitle': 'A Phase 3, Multicenter, Open-Label Study to Assess the Long-Term Safety of REL-1017 as a Treatment of Major Depressive Disorder', 'orgStudyIdInfo': {'id': 'REL-1017-310'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'REL-1017', 'description': 'Roll-over participants received 25 mg REL-1017 (one 25 mg REL-1017 tablet), orally, per day, either as a monotherapy or in addition to their ongoing antidepressant (ADT), rolling over from the monotherapy study REL-1017-303 or the adjunctive therapy studies REL-1017-301 and REL-1017-302, respectively.\n\nDe Novo participants received a 75 mg REL-1017 loading dose (three 25 mg REL-1017 tablets) on Day-1 of the 365-day treatment period. From Day-2 to Day-365, participants received 25 mg REL-1017 either as monotherapy or as adjunctive therapy.', 'interventionNames': ['Drug: REL-1017']}], 'interventions': [{'name': 'REL-1017', 'type': 'DRUG', 'otherNames': ['Esmethadone HCl'], 'description': 'REL-1017 tablet', 'armGroupLabels': ['REL-1017']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33015', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Relmada Site', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33175', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Relmada Site', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '32801', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Relmada Site', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '32905', 'city': 'Palm Bay', 'state': 'Florida', 'country': 'United States', 'facility': 'Relmada Site', 'geoPoint': {'lat': 28.03446, 'lon': -80.58866}}, {'zip': '60634', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Relmada Site', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60640', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Relmada Site', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '02116', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Relmada Site', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02472', 'city': 'Watertown', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Relmada Site', 'geoPoint': {'lat': 42.37093, 'lon': -71.18283}}, {'zip': '10312', 'city': 'Staten Island', 'state': 'New York', 'country': 'United States', 'facility': 'Relmada Site', 'geoPoint': {'lat': 40.56233, 'lon': -74.13986}}], 'overallOfficials': [{'name': 'Marco Pappagallo, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Relmada Therapeutics'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Relmada Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}