Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2025-12-26 @ 2:03 AM
Study NCT ID:
NCT06235905
Status:
COMPLETED
Last Update Posted:
2025-10-21
First Post:
2024-01-23
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Open-Label of SPN-820 in Adults With Major Depressive Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003865', 'term': 'Depressive Disorder, Major'}], 'ancestors': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000711091', 'term': 'NV-5138'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'gceresoliborroni@supernus.com', 'phone': '3018382521', 'title': 'Senior Director Clinical Development', 'organization': 'Navitorpharma'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Treatment Emergent Adverse Events (TEAEs) were collected after the first dose of study medication up to 12 days (i.e., safety follow up phone call 5 days after the last dose of study medication).', 'description': 'Treatment Emergent Adverse Event (TEAE) is an adverse event (AE) with a start date on or after the first dose of study medication is taken, or that worsened following first administration of study medication.', 'eventGroups': [{'id': 'EG000', 'title': 'SPN-820 (2400 mg)', 'description': 'SPN-820 (2400 mg) oral capsules\n\nParticipants received SPN-820 6 x 400 mg capsules administered orally every 3 days for a 7-day treatment period.', 'otherNumAtRisk': 40, 'deathsNumAtRisk': 40, 'otherNumAffected': 25, 'seriousNumAtRisk': 40, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.1'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 8, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.1'}, {'term': 'Cognitive Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.1'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.1'}, {'term': 'Paraesthesia oral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 5, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.1'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline to Each Time Point in the Hamilton Depression Rating Scale-6 Items (HAM-D6) Total Score (HAM-D6).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SPN-820 (2400 mg)', 'description': 'SPN-820 (2400 mg) oral capsules\n\nParticipants received SPN-820 6 x 400 mg capsules administered orally every 3 days for a 7-day treatment period.'}], 'classes': [{'title': 'Day 1 - 2 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-6.1', 'spread': '3.90', 'groupId': 'OG000'}]}]}, {'title': 'Day 1 - 4 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-7.2', 'spread': '3.96', 'groupId': 'OG000'}]}]}, {'title': 'Day 1 - 8 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-7.5', 'spread': '3.59', 'groupId': 'OG000'}]}]}, {'title': 'Day 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-7.8', 'spread': '3.58', 'groupId': 'OG000'}]}]}, {'title': 'Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-8.7', 'spread': '3.47', 'groupId': 'OG000'}]}]}, {'title': 'Day 4 - Predose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-7.2', 'spread': '3.04', 'groupId': 'OG000'}]}]}, {'title': 'Day 4 - 2 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-8.9', 'spread': '3.45', 'groupId': 'OG000'}]}]}, {'title': 'Day 4 - 4 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-9.5', 'spread': '3.33', 'groupId': 'OG000'}]}]}, {'title': 'Day 4 - 8 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-9.7', 'spread': '3.33', 'groupId': 'OG000'}]}]}, {'title': 'Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-9.3', 'spread': '3.37', 'groupId': 'OG000'}]}]}, {'title': 'Day 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-9.8', 'spread': '3.22', 'groupId': 'OG000'}]}]}, {'title': 'Day 7 - Predose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-9.2', 'spread': '3.38', 'groupId': 'OG000'}]}]}, {'title': 'Day 7 - 2 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-9.9', 'spread': '3.09', 'groupId': 'OG000'}]}]}, {'title': 'Day 7 - 4 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-9.7', 'spread': '3.11', 'groupId': 'OG000'}]}]}, {'title': 'Day 7 - 8 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-10.2', 'spread': '3.21', 'groupId': 'OG000'}]}]}, {'title': 'Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-9.8', 'spread': '3.15', 'groupId': 'OG000'}]}]}, {'title': 'Day 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-9.9', 'spread': '2.67', 'groupId': 'OG000'}]}]}, {'title': 'Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-9.6', 'spread': '3.18', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '10 days (end of study)', 'description': 'The HAM-D6 scale consists of 6 items: five of them (depressed mood, work and activities, feeling of guilt, anxiety, psychic, retardation) are scored on a scale of 0 to 4, and one item (somatic symptoms general) is scored on a scale 0 to 2. The total score is the sum of the 6 items ranging from 0 to 22, higher scores indicate severe depression, and lower scores are better outcomes.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) Population: the FAS includes all participants who receive at least one dose of study medication and have a baseline and at least one post-baseline measurement of HAM-D6.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Each Time Point in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SPN-820 (2400 mg)', 'description': 'SPN-820 (2400 mg) oral capsules\n\nParticipants received SPN-820 6 x 400 mg capsules administered orally every 3 days for a 7-day treatment period.'}], 'classes': [{'title': 'Day 1 - 4 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-16.6', 'spread': '10.06', 'groupId': 'OG000'}]}]}, {'title': 'Day 4 - Predose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-16.6', 'spread': '9.05', 'groupId': 'OG000'}]}]}, {'title': 'Day 4 - 4 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-21.2', 'spread': '9.93', 'groupId': 'OG000'}]}]}, {'title': 'Day 7 - Predose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-21.2', 'spread': '9.83', 'groupId': 'OG000'}]}]}, {'title': 'Day 7 - 4 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-23.3', 'spread': '10.60', 'groupId': 'OG000'}]}]}, {'title': 'Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-22.9', 'spread': '9.98', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '10 days (end of study)', 'description': 'MADRS is a 10-item scale (Reported sadness, Apparent sadness, Inner tension, Reduced sleep, Reduced appetite, Concentration difficulties, Lassitude, Inability to feel, Pessimist thoughts, and Suicidal thoughts) where each item is scored from 0 to 6. The total score is the sum of the 10 items ranging from 0 to 60 where higher scores indicate more severe depression, and lower scores are better outcomes.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) Population: the FAS includes all participants who receive at least one dose of study medication and have a baseline and at least one post-baseline measurement of HAM-D6.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Each Time Point in the Clinical Global Impression - Severity of Illness Score (CGI-S).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SPN-820 (2400 mg)', 'description': 'SPN-820 (2400 mg) oral capsules\n\nParticipants received SPN-820 6 x 400 mg capsules administered orally every 3 days for a 7-day treatment period.'}], 'classes': [{'title': 'Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.5', 'spread': '1.08', 'groupId': 'OG000'}]}]}, {'title': 'Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.2', 'spread': '1.21', 'groupId': 'OG000'}]}]}, {'title': 'Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.4', 'spread': '1.35', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '10 days (end of study)', 'description': 'CGI-S is a single-item clinician rating of the clinician\'s assessment of the severity of symptoms in relation to the clinician\'s total experience with patients with that condition. The CGI-I is rated on a 7-point scale from 1 to 7, where 1 = "normal not at all ill" and 7 = "among the most extremely ill patients". Successful therapy is indicated by a lower overall score.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) Population: the FAS includes all participants who receive at least one dose of study medication and have a baseline and at least one post-baseline measurement of HAM-D6.'}, {'type': 'SECONDARY', 'title': 'Suicidal Ideation and Behavior as Measured by the Columbia-Suicide Severity Rating Scale (C-SSRS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SPN-820 (2400 mg)', 'description': 'SPN-820 (2400 mg) oral capsules\n\nParticipants received SPN-820 6 x 400 mg capsules administered orally every 3 days for a 7-day treatment period.'}], 'classes': [{'title': 'Day 1 (Baseline) - Suicidal Ideation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Day 1 (Baseline) - Behavior', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Day 4 - Suicidal Ideation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Day 4 - Suicidal Behavior', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Day 7 - Suicidal Ideation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Day 7 - Suicidal Behavior', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Day 10 - Suicidal Ideation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 10 - Suicidal Behavior', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '10 days (end of study)', 'description': 'C-SSRS assessment included "yes" or "no" responses for 5 questions, each related to suicidal ideation (wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with any methods, active suicidal ideation with some intent, active suicidal ideation with specific plan) and suicidal behavior (preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, suicide). Number of participants with a response of \'yes\' to any suicidal ideation or suicidal behavior item as measured by C-SSRS is reported.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants reported here is based on the Safety Population, which includes participants who took at least one dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Incidence of Treatment Emergent Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SPN-820 (2400 mg)', 'description': 'SPN-820 (2400 mg) oral capsules\n\nParticipants received SPN-820 6 x 400 mg capsules administered orally every 3 days for a 7-day treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '62.5', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '10 days (end of study)', 'description': 'The incidence of treatment-emergent adverse events (TEAEs) was measured as the percent of participants who took at least one dose of SPN-820 and reported at least one adverse event during 10 days of adjunct treatment. The percent is calculated by dividing "the number of participants who reported at least one Adverse Event" by "the number of participants in the Safety Population" and then multiplying the product by 100. The higher the percent, the higher the incidence.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants reported here is based on the Safety Population, which includes participants who took at least one dose of study medication.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'SPN-820 (2400 mg)', 'description': 'SPN-820 (2400 mg) oral capsules\n\nParticipants received SPN-820 6 x 400 mg capsules administered orally every 3 days for a 7-day treatment period.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'The number of participants reported here is based on the Safety Population which includes all participants who took at least one dose of study medication.', 'groupId': 'FG000', 'numSubjects': '40'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '38'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Non-compliant with protocol procedures', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'SPN-820 (2400 mg)', 'description': 'SPN-820 (2400 mg) oral capsules\n\nParticipants received SPN-820 6 x 400 mg capsules administered orally every 3 days for a 7-day treatment period.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '44.7', 'spread': '15.39', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '27', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '24', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '32', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'MADRS Total Score', 'classes': [{'categories': [{'measurements': [{'value': '33.1', 'spread': '5.41', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'The Montgomery-Åsberg Depression Rating Scale is a diagnostic questionnaire used to measure the severity of depressive episodes. It consists of 10 items (reported sadness, apparent sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, suicidal thoughts) and each question is scored from 0 to 6 for a total score ranging 0 to 60. Higher scores indicate more severe conditions.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'HAM-D6 Total Score', 'classes': [{'categories': [{'measurements': [{'value': '13.6', 'spread': '1.69', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'The Hamilton Depression Rating Scale - 6 Items is a diagnostic questionnaire used to measure the severity of depressive episodes. It consists of 6 items (depressed mood, work and activities, somatic symptoms general, feeling of guilt, anxiety psychic, retardation) and each question is scored from 0 to 4 except for one item, somatic symptoms general, which is scored from 0 - 2 for a total score ranging 0 to 22. Higher scores indicate more severe conditions.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'CGI-S', 'classes': [{'categories': [{'measurements': [{'value': '4.6', 'spread': '0.64', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': "The Clinical Global Impression - Severity of Illness is a single-item clinician rating of the clinician's assessment of the severity of symptoms in relation to the clinician's total experience with patients with that condition. CGI-S is evaluated by the Investigator on a 7- point scale with 1=Normal, 2=Borderline ill, 3=Mildly ill, 4=Moderately ill, 5=Markedly ill, 6=Severely ill, and 7=Extremely ill.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'The number of participants reported here is based on the Safety Population, which includes participants who took at least one dose of study medication.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-02-14', 'size': 3608249, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-09-10T11:26', 'hasProtocol': True}, {'date': '2024-08-23', 'size': 1006811, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-08-14T15:14', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Open-label'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-02-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2024-08-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-06', 'studyFirstSubmitDate': '2024-01-23', 'resultsFirstSubmitDate': '2025-10-06', 'studyFirstSubmitQcDate': '2024-01-23', 'lastUpdatePostDateStruct': {'date': '2025-10-21', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-10-06', 'studyFirstPostDateStruct': {'date': '2024-02-01', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-10-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-08-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline to Each Time Point in the Hamilton Depression Rating Scale-6 Items (HAM-D6) Total Score (HAM-D6).', 'timeFrame': '10 days (end of study)', 'description': 'The HAM-D6 scale consists of 6 items: five of them (depressed mood, work and activities, feeling of guilt, anxiety, psychic, retardation) are scored on a scale of 0 to 4, and one item (somatic symptoms general) is scored on a scale 0 to 2. The total score is the sum of the 6 items ranging from 0 to 22, higher scores indicate severe depression, and lower scores are better outcomes.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline to Each Time Point in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score.', 'timeFrame': '10 days (end of study)', 'description': 'MADRS is a 10-item scale (Reported sadness, Apparent sadness, Inner tension, Reduced sleep, Reduced appetite, Concentration difficulties, Lassitude, Inability to feel, Pessimist thoughts, and Suicidal thoughts) where each item is scored from 0 to 6. The total score is the sum of the 10 items ranging from 0 to 60 where higher scores indicate more severe depression, and lower scores are better outcomes.'}, {'measure': 'Change From Baseline to Each Time Point in the Clinical Global Impression - Severity of Illness Score (CGI-S).', 'timeFrame': '10 days (end of study)', 'description': 'CGI-S is a single-item clinician rating of the clinician\'s assessment of the severity of symptoms in relation to the clinician\'s total experience with patients with that condition. The CGI-I is rated on a 7-point scale from 1 to 7, where 1 = "normal not at all ill" and 7 = "among the most extremely ill patients". Successful therapy is indicated by a lower overall score.'}, {'measure': 'Suicidal Ideation and Behavior as Measured by the Columbia-Suicide Severity Rating Scale (C-SSRS)', 'timeFrame': '10 days (end of study)', 'description': 'C-SSRS assessment included "yes" or "no" responses for 5 questions, each related to suicidal ideation (wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with any methods, active suicidal ideation with some intent, active suicidal ideation with specific plan) and suicidal behavior (preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, suicide). Number of participants with a response of \'yes\' to any suicidal ideation or suicidal behavior item as measured by C-SSRS is reported.'}, {'measure': 'Incidence of Treatment Emergent Adverse Events', 'timeFrame': '10 days (end of study)', 'description': 'The incidence of treatment-emergent adverse events (TEAEs) was measured as the percent of participants who took at least one dose of SPN-820 and reported at least one adverse event during 10 days of adjunct treatment. The percent is calculated by dividing "the number of participants who reported at least one Adverse Event" by "the number of participants in the Safety Population" and then multiplying the product by 100. The higher the percent, the higher the incidence.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Major Depressive Disorder']}, 'descriptionModule': {'briefSummary': 'This study will evaluate of the efficacy and safety of SPN-820 in Adults With Major Depressive Disorder (MDD)', 'detailedDescription': 'This is an open-label study of adjunctive SPN-820 (2400 mg) administered orally once every 3 days in adults with MDD'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female subject, aged 18 to 65 years (inclusive) at screening.\n* Diagnosis of MDD according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) for either recurrent or single episode MDD without psychotic features that is confirmed by the Mini International Neuropsychiatric Interview (MINI) at screening.\n* MADRS total score of ≥22 for the current major depressive episode (MDE) at screening and baseline (day 1) before study medication (SM) administration.\n* CGI-S score of ≥4 (moderately ill or worse) at screening and baseline (day 1) before SM administration.\n* Stable, therapeutic dose of one of the following protocol-defined ADTs for the current MDE for ≥6 weeks prior to screening: citalopram, escitalopram, paroxetine, fluoxetine, sertraline, duloxetine, venlafaxine (immediate release or extended release), desvenlafaxine, vilazodone, levomilnacipran, vortioxetine, bupropion, or dextromethorphan/bupropion.\n* Stable therapeutic dose of the approved ADT throughout the study.\n\nExclusion Criteria:\n\n* MADRS total score improvement of ≥25% from the highest to the lowest score from screening to baseline.\n* Clinically significant abnormal laboratory profiles, vital sign measurements, or ECGs prior to baseline.\n* Lifetime history of psychotic disorder, including but not limited to schizophrenia, MDD with psychotic features, or bipolar I/II disorder with and without psychotic features.\n* Diagnosis within the last 12 months before screening or current diagnosis of PTSD, OCD, panic disorder, acute stress disorder, or has a history of intellectual disability, autism, or cluster A or B personality disorder.\n* Suicidal behavior or suicidal ideation of type 4 or type 5 based on the C-SSRS in the 1 year before screening; a history of suicide attempt in the last 2 years; or more than 2 lifetime suicide attempts.\n* History of substance use disorder within 6 months prior to screening or is currently using or has a positive result (urine drug screen) at screening or baseline for drugs of abuse.\n* History of alcohol use disorder within 6 months prior to screening.\n* In the investigator's opinion, is unlikely to comply with the protocol or is unsuitable for any other reason."}, 'identificationModule': {'nctId': 'NCT06235905', 'briefTitle': 'Open-Label of SPN-820 in Adults With Major Depressive Disorder', 'organization': {'class': 'INDUSTRY', 'fullName': 'Navitor Pharmaceuticals, Inc.'}, 'officialTitle': 'An Open-Label, Single-Group Study to Evaluate the Efficacy and Safety of SPN-820 in Adults With Major Depressive Disorder', 'orgStudyIdInfo': {'id': 'NAV-17A-008'}, 'secondaryIdInfos': [{'id': 'SPN-820', 'type': 'OTHER', 'domain': 'Supernus Pharmaceuticals'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'SPN-820 6 x 400 mg capsules', 'interventionNames': ['Drug: NV-5138']}], 'interventions': [{'name': 'NV-5138', 'type': 'DRUG', 'otherNames': ['SPN-820'], 'description': 'NV-5138 is a novel, orally bioavailable, mechanistic target of rapamycin complex 1 (mTORC1) signaling enhancer', 'armGroupLabels': ['SPN-820 6 x 400 mg capsules']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92591', 'city': 'Temecula', 'state': 'California', 'country': 'United States', 'facility': 'Viking Clinical Research', 'geoPoint': {'lat': 33.49364, 'lon': -117.14836}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Navitor Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Supernus Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}