Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2026-03-04 @ 12:44 PM
Study NCT ID:
NCT03228394
Status:
COMPLETED
Last Update Posted:
2023-07-19
First Post:
2017-07-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Clinical Trial of Intravenous (IV) Ganaxolone in Women With Postpartum Depression
Sponsor:
Organization:
Raw JSON
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'phone': '484-801-4670', 'title': 'Marinus Clinical Trials Submission Manager', 'organization': 'Marinus Pharmaceuticals, Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Baseline up to 71 days', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo Cohort 1', 'description': 'IV infusion of PBO at rate of 16 mL/h for 48 hours, then 8 mL/h for 12 hours', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 1, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Ganaxolone Cohort 1', 'description': 'IV infusion of GNX at rate of 4 mg/h (16 mL/h) for 48 hours, then 2 mg/h for 12 hours', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 2, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Placebo Cohort 2', 'description': 'IV infusion of PBO at rate of 16 mL/h for 48 hours, then 8 mL/h for 12 hours', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 3, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Ganaxolone Cohort 2', 'description': 'IV infusion of GNX at rate of 8 mg/h for 48 hours, then 4 mg/h (8 mL/h) for 12 hours', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 5, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Placebo Cohort 3', 'description': 'IV bolus of 24 mL PBO over 2 minutes; then 24 mL/h for 48 hours and then 12 mL/h for 12 hours', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 3, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Ganaxolone Cohort 3', 'description': 'IV bolus of 12 mg (24mL) GNX over 2 minutes; then GNX at 12 mg/h (24 mL/h) for 48 hours and then 6 mg/h (12 mL/h) for 12 hours', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 8, 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'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}], 'seriousEvents': [{'term': 'Suicide Attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Hamilton Depression Rating Scale 17-item Version (HAMD17) Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '14', 'groupId': 'OG006'}, {'value': '15', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Cohort 1', 'description': 'IV infusion of PBO at rate of 16 mL/h for 48 hours, then 8 mL/h for 12 hours'}, {'id': 'OG001', 'title': 'Ganaxolone Cohort 1', 'description': 'IV infusion of GNX at rate of 4 mg/h (16 mL/h) for 48 hours, then 2 mg/h for 12 hours'}, {'id': 'OG002', 'title': 'Placebo Cohort 2', 'description': 'IV infusion of PBO at rate of 16 mL/h for 48 hours, then 8 mL/h for 12 hours'}, {'id': 'OG003', 'title': 'Ganaxolone Cohort 2', 'description': 'IV infusion of GNX at rate of 8 mg/h for 48 hours, then 4 mg/h (8 mL/h) for 12 hours'}, {'id': 'OG004', 'title': 'Placebo Cohort 3', 'description': 'IV bolus of 24 mL PBO over 2 minutes; then 24 mL/h for 48 hours and then 12 mL/h for 12 hours'}, {'id': 'OG005', 'title': 'Ganaxolone Cohort 3', 'description': 'IV bolus of 12 mg (24mL) GNX over 2 minutes; then GNX at 12 mg/h (24 mL/h) for 48 hours and then 6 mg/h (12 mL/h) for 12 hours'}, {'id': 'OG006', 'title': 'Placebo Cohort 6', 'description': 'IV infusion of PBO at rate of 40 mL/h for 6 hours; then 900 mg PBO (4 capsules) orally at dinner for 28 days'}, {'id': 'OG007', 'title': 'Ganaxolone Cohort 6', 'description': 'IV infusion of GNX at rate of 20 mg/h (40 mL/h) for 6 hours followed by 900 mg (4 capsules) orally at dinner for 28 days'}], 'classes': [{'title': 'Day 3 post-infusion (60 hours post start of infusion)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '-13.0', 'spread': '10.10', 'groupId': 'OG000'}, {'value': '-12.0', 'spread': '6.82', 'groupId': 'OG001'}, {'value': '-14.0', 'spread': '9.10', 'groupId': 'OG002'}, {'value': '-14.3', 'spread': '10.23', 'groupId': 'OG003'}, {'value': '-11.0', 'spread': '6.58', 'groupId': 'OG004'}, {'value': '-11.3', 'spread': '7.04', 'groupId': 'OG005'}]}]}, {'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '14', 'groupId': 'OG006'}, {'value': '15', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '-13.6', 'spread': '11.51', 'groupId': 'OG006'}, {'value': '-11.5', 'spread': '11.43', 'groupId': 'OG007'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Day 3 post-infusion (60 hours post start of infusion) for Cohorts 1 to 3 and Baseline and Day 29 for Cohort 6', 'description': 'The HAMD17 was a 17-item clinician-rated instrument used to assess the range of symptoms that were most frequently observed in participants with major depression. All items were scored on an ordinal scale between 0 and 4 (8 items) or 0 and 2 (9 items) of increasing severity. Each of 17 items was rated by clinician with rating of 0: absent, 1: doubtful to mild, 2: mild to moderate, 3: moderate to severe, and 4: very severe. A total score (0 to 52) was calculated by adding scores of all 17 items, where 0 indicated no depression and 52 indicated severe depression. Higher score represented more severe condition. Baseline was defined as the Day 1 assessment before study drug infusion. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent-to-treat (mITT) population: Included all participants in the safety set who had ≥1 post-randomization efficacy assessment. Only those participants with data available at the specified data points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in HAMD17 Total Score at Indicated Time Points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '17', 'groupId': 'OG006'}, {'value': '16', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Cohort 1', 'description': 'IV infusion of PBO at rate of 16 mL/h for 48 hours, then 8 mL/h for 12 hours'}, {'id': 'OG001', 'title': 'Ganaxolone Cohort 1', 'description': 'IV infusion of GNX at rate of 4 mg/h (16 mL/h) for 48 hours, then 2 mg/h for 12 hours'}, {'id': 'OG002', 'title': 'Placebo Cohort 2', 'description': 'IV infusion of PBO at rate of 16 mL/h for 48 hours, then 8 mL/h for 12 hours'}, {'id': 'OG003', 'title': 'Ganaxolone Cohort 2', 'description': 'IV infusion of GNX at rate of 8 mg/h for 48 hours, then 4 mg/h (8 mL/h) for 12 hours'}, {'id': 'OG004', 'title': 'Placebo Cohort 3', 'description': 'IV bolus of 24 mL PBO over 2 minutes; then 24 mL/h for 48 hours and then 12 mL/h for 12 hours'}, {'id': 'OG005', 'title': 'Ganaxolone Cohort 3', 'description': 'IV bolus of 12 mg (24mL) GNX over 2 minutes; then GNX at 12 mg/h (24 mL/h) for 48 hours and then 6 mg/h (12 mL/h) for 12 hours'}, {'id': 'OG006', 'title': 'Placebo Cohort 6', 'description': 'IV infusion of PBO at rate of 40 mL/h for 6 hours; then 900 mg PBO (4 capsules) orally at dinner for 28 days'}, {'id': 'OG007', 'title': 'Ganaxolone Cohort 6', 'description': 'IV infusion of GNX at rate of 20 mg/h (40 mL/h) for 6 hours followed by 900 mg (4 capsules) orally at dinner for 28 days'}], 'classes': [{'title': 'Day 1 post-infusion (6 hours post start of infusion)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '17', 'groupId': 'OG006'}, {'value': '16', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '-3.2', 'spread': '6.85', 'groupId': 'OG006'}, {'value': '-6.1', 'spread': '9.97', 'groupId': 'OG007'}]}]}, {'title': 'Day 1 (12 hours post start of infusion)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '-3.8', 'spread': '7.18', 'groupId': 'OG000'}, {'value': '-2.4', 'spread': '1.52', 'groupId': 'OG001'}, {'value': '-3.2', 'spread': '6.44', 'groupId': 'OG002'}, {'value': '-2.7', 'spread': '5.59', 'groupId': 'OG003'}, {'value': '-1.9', 'spread': '4.20', 'groupId': 'OG004'}, {'value': '0.3', 'spread': '2.92', 'groupId': 'OG005'}]}]}, {'title': 'Day 2 (24 hours post start of infusion)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '17', 'groupId': 'OG006'}, {'value': '16', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '-8.0', 'spread': '9.80', 'groupId': 'OG000'}, {'value': '-3.8', 'spread': '5.31', 'groupId': 'OG001'}, {'value': '-6.4', 'spread': '7.33', 'groupId': 'OG002'}, {'value': '-10.1', 'spread': '8.90', 'groupId': 'OG003'}, {'value': '-5.2', 'spread': '7.89', 'groupId': 'OG004'}, {'value': '-3.4', 'spread': '4.13', 'groupId': 'OG005'}, {'value': '-5.1', 'spread': '5.07', 'groupId': 'OG006'}, {'value': '-7.8', 'spread': '8.07', 'groupId': 'OG007'}]}]}, {'title': 'Day 3 post-infusion (48 hours post start of infusion)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '-10.8', 'spread': '12.09', 'groupId': 'OG000'}, {'value': '-11.0', 'spread': '3.67', 'groupId': 'OG001'}, {'value': '-10.5', 'spread': '9.26', 'groupId': 'OG002'}, {'value': '-13.7', 'spread': '11.68', 'groupId': 'OG003'}, {'value': '-8.7', 'spread': '7.15', 'groupId': 'OG004'}, {'value': '-11.2', 'spread': '4.98', 'groupId': 'OG005'}]}]}, {'title': 'Day 4 (72 hours post start of infusion)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '16', 'groupId': 'OG006'}, {'value': '13', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '-12.8', 'spread': '14.73', 'groupId': 'OG000'}, {'value': '-10.2', 'spread': '10.06', 'groupId': 'OG001'}, {'value': '-14.5', 'spread': '9.12', 'groupId': 'OG002'}, {'value': '-17.3', 'spread': '9.22', 'groupId': 'OG003'}, {'value': '-14.0', 'spread': '6.72', 'groupId': 'OG004'}, {'value': '-10.5', 'spread': '8.57', 'groupId': 'OG005'}, {'value': '-7.8', 'spread': '6.83', 'groupId': 'OG006'}, {'value': '-7.0', 'spread': '6.16', 'groupId': 'OG007'}]}]}, {'title': 'Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '13', 'groupId': 'OG006'}, {'value': '15', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '-8.7', 'spread': '8.99', 'groupId': 'OG006'}, {'value': '-8.7', 'spread': '9.17', 'groupId': 'OG007'}]}]}, {'title': 'Day 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '11', 'groupId': 'OG006'}, {'value': '11', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '-13.3', 'spread': '11.79', 'groupId': 'OG000'}, {'value': '-6.2', 'spread': '5.72', 'groupId': 'OG001'}, {'value': '-9.7', 'spread': '9.67', 'groupId': 'OG002'}, {'value': '-14.0', 'spread': '12.56', 'groupId': 'OG003'}, {'value': '-8.2', 'spread': '7.80', 'groupId': 'OG004'}, {'value': '-8.9', 'spread': '9.65', 'groupId': 'OG005'}, {'value': '-13.6', 'spread': '7.58', 'groupId': 'OG006'}, {'value': '-13.6', 'spread': '9.84', 'groupId': 'OG007'}]}]}, {'title': 'Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '16', 'groupId': 'OG006'}, {'value': '13', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '-11.6', 'spread': '8.38', 'groupId': 'OG006'}, {'value': '-12.7', 'spread': '9.72', 'groupId': 'OG007'}]}]}, {'title': 'Day 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '15', 'groupId': 'OG006'}, {'value': '15', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '-12.3', 'spread': '10.50', 'groupId': 'OG006'}, {'value': '-12.7', 'spread': '9.55', 'groupId': 'OG007'}]}]}, {'title': 'Day 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '12', 'groupId': 'OG006'}, {'value': '15', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '-17.0', 'spread': '12.46', 'groupId': 'OG000'}, {'value': '-11.0', 'spread': '9.62', 'groupId': 'OG001'}, {'value': '-13.3', 'spread': '6.48', 'groupId': 'OG002'}, {'value': '-16.5', 'spread': '10.10', 'groupId': 'OG003'}, {'value': '-9.1', 'spread': '8.70', 'groupId': 'OG004'}, {'value': '-11.1', 'spread': '12.25', 'groupId': 'OG005'}, {'value': '-13.5', 'spread': '10.76', 'groupId': 'OG006'}, {'value': '-13.0', 'spread': '10.11', 'groupId': 'OG007'}]}]}, {'title': 'Day 57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '12', 'groupId': 'OG006'}, {'value': '12', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '-16.0', 'spread': '9.70', 'groupId': 'OG006'}, {'value': '-12.0', 'spread': '9.49', 'groupId': 'OG007'}]}]}, {'title': 'Day 71', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '12', 'groupId': 'OG006'}, {'value': '13', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '-19.0', 'spread': '7.87', 'groupId': 'OG006'}, {'value': '-14.8', 'spread': '11.52', 'groupId': 'OG007'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day1 post-infusion(6hours post start of infusion), Day1(12hours post start of infusion), Day2(24hours post start of infusion),Day3 post-infusion(48hours post start of infusion),Day4(72hours post start of infusion),Days 8,11,15,22,36,57 and 71', 'description': 'The HAMD17 was a 17-item clinician-rated instrument used to assess the range of symptoms that were most frequently observed in participants with major depression. All items were scored on an ordinal scale between 0 and 4 (8 items) or 0 and 2 (9 items) of increasing severity. Each of 17 items was rated by clinician with rating of 0: absent, 1: doubtful to mild, 2: mild to moderate, 3: moderate to severe, and 4: very severe. A total score (0 to 52) was calculated by adding scores of all 17 items, where 0 indicated no depression and 52 indicated severe depression. Higher score represented more severe condition. Baseline was defined as the Day 1 assessment before study drug infusion. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population. Only those participants with data available at the specified data points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With HAMD17 Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '17', 'groupId': 'OG006'}, {'value': '16', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Cohort 1', 'description': 'IV infusion of PBO at rate of 16 mL/h for 48 hours, then 8 mL/h for 12 hours'}, {'id': 'OG001', 'title': 'Ganaxolone Cohort 1', 'description': 'IV infusion of GNX at rate of 4 mg/h (16 mL/h) for 48 hours, then 2 mg/h for 12 hours'}, {'id': 'OG002', 'title': 'Placebo Cohort 2', 'description': 'IV infusion of PBO at rate of 16 mL/h for 48 hours, then 8 mL/h for 12 hours'}, {'id': 'OG003', 'title': 'Ganaxolone Cohort 2', 'description': 'IV infusion of GNX at rate of 8 mg/h for 48 hours, then 4 mg/h (8 mL/h) for 12 hours'}, {'id': 'OG004', 'title': 'Placebo Cohort 3', 'description': 'IV bolus of 24 mL PBO over 2 minutes; then 24 mL/h for 48 hours and then 12 mL/h for 12 hours'}, {'id': 'OG005', 'title': 'Ganaxolone Cohort 3', 'description': 'IV bolus of GNX 12 mg (24mL) over 2 min; then 12 mg/h (24mL/h) for 48hrs.'}, {'id': 'OG006', 'title': 'Placebo Cohort 6', 'description': 'IV infusion of PBO at rate of 40 mL/h for 6 hours; then 900 mg PBO (4 capsules) orally at dinner for 28 days'}, {'id': 'OG007', 'title': 'Ganaxolone Cohort 6', 'description': 'IV infusion of GNX at rate of 20 mg/h (40 mL/h) for 6 hours followed by 900 mg (4 capsules) orally at dinner for 28 days'}], 'classes': [{'title': 'Day 1 post-infusion (6 hours post start of infusion): Responder', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '17', 'groupId': 'OG006'}, {'value': '16', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}]}]}, {'title': 'Day 1 (12 hours post start of infusion): Responder', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Day 2 (24 hours post start of infusion): Responder', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '17', 'groupId': 'OG006'}, {'value': '16', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}]}]}, {'title': 'Day 3 post-infusion (48 hours post start of infusion): Responder', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}]}, {'title': 'Day 3 post-infusion (60 hours post start of infusion): Responder', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}]}, {'title': 'Day 4 (72 hours post start of infusion): Responder', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '16', 'groupId': 'OG006'}, {'value': '13', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}]}]}, {'title': 'Day 8: Responder', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '13', 'groupId': 'OG006'}, {'value': '15', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}]}]}, {'title': 'Day 11: Responder', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '11', 'groupId': 'OG006'}, {'value': '11', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}]}]}, {'title': 'Day 15: Responder', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '16', 'groupId': 'OG006'}, {'value': '13', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}]}]}, {'title': 'Day 22: Responder', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '15', 'groupId': 'OG006'}, {'value': '15', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG006'}, {'value': '8', 'groupId': 'OG007'}]}]}, {'title': 'Day 29: Responder', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '14', 'groupId': 'OG006'}, {'value': '15', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG006'}, {'value': '7', 'groupId': 'OG007'}]}]}, {'title': 'Day 36: Responder', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '12', 'groupId': 'OG006'}, {'value': '15', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '8', 'groupId': 'OG007'}]}]}, {'title': 'Day 57: Responder', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '12', 'groupId': 'OG006'}, {'value': '12', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}]}]}, {'title': 'Day 71: Responder', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '12', 'groupId': 'OG006'}, {'value': '13', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG006'}, {'value': '9', 'groupId': 'OG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day1 post-infusion (6 hours post start of infusion [SOI]), Day 1 (12 hours post SOI), Day 2 (24 hours post SOI),Day 3 post-infusion (48 hours post SOI), Day 3 post-infusion (60 hours post SOI), Day 4 (72 hours post SOI), Days 8,11,15,22,29,36,57 and 71', 'description': 'HAMD17 Response was defined as ≥50% reduction from Baseline in total score. The HAMD17 was a 17-item clinician-rated instrument used to assess the range of symptoms that were most frequently observed in participants with major depression. All items were scored on an ordinal scale between 0 and 4 (8 items) or 0 and 2 (9 items) of increasing severity. Each of 17 items was rated by clinician with rating of 0: absent, 1: doubtful to mild, 2: mild to moderate, 3: moderate to severe, and 4: very severe. A total score (0 to 52) was calculated by adding scores of all 17 items, where 0 indicated no depression and 52 indicated severe depression. Higher score represented more severe condition. Number of participants with HAMD17 response is presented.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population. Only those participants with data available at the specified data points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With HAMD17 Remission', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '17', 'groupId': 'OG006'}, {'value': '16', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Cohort 1', 'description': 'IV infusion of PBO at rate of 16 mL/h for 48 hours, then 8 mL/h for 12 hours'}, {'id': 'OG001', 'title': 'Ganaxolone Cohort 1', 'description': 'IV infusion of GNX at rate of 4 mg/h (16 mL/h) for 48 hours, then 2 mg/h for 12 hours'}, {'id': 'OG002', 'title': 'Placebo Cohort 2', 'description': 'IV infusion of PBO at rate of 16 mL/h for 48 hours, then 8 mL/h for 12 hours'}, {'id': 'OG003', 'title': 'Ganaxolone Cohort 2', 'description': 'IV infusion of GNX at rate of 8 mg/h for 48 hours, then 4 mg/h (8 mL/h) for 12 hours'}, {'id': 'OG004', 'title': 'Placebo Cohort 3', 'description': 'IV bolus of 24 mL PBO over 2 minutes; then 24 mL/h for 48 hours and then 12 mL/h for 12 hours'}, {'id': 'OG005', 'title': 'Ganaxolone Cohort 3', 'description': 'IV bolus of 12 mg (24mL) GNX over 2 minutes; then GNX at 12 mg/h (24 mL/h) for 48 hours and then 6 mg/h (12 mL/h) for 12 hours'}, {'id': 'OG006', 'title': 'Placebo Cohort 6', 'description': 'IV infusion of PBO at rate of 40 mL/h for 6 hours; then 900 mg PBO (4 capsules) orally at dinner for 28 days'}, {'id': 'OG007', 'title': 'Ganaxolone Cohort 6', 'description': 'IV infusion of GNX at rate of 20 mg/h (40 mL/h) for 6 hours followed by 900 mg (4 capsules) orally at dinner for 28 days'}], 'classes': [{'title': 'Day 1 post-infusion (6 hours post start of infusion): Remission', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '17', 'groupId': 'OG006'}, {'value': '16', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}]}]}, {'title': 'Day 1 (12 hours post start of infusion): Remission', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Day 2 (24 hours post start of infusion): Remission', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '17', 'groupId': 'OG006'}, {'value': '16', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}]}]}, {'title': 'Day 3 post-infusion (48 hours post start of infusion): Remission', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}]}, {'title': 'Day 3 post-infusion (60 hours post start of infusion): Remission', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}]}, {'title': 'Day 4 (72 hours post start of infusion): Remission', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '16', 'groupId': 'OG006'}, {'value': '13', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Day 8: Remission', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '13', 'groupId': 'OG006'}, {'value': '15', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}]}]}, {'title': 'Day 11: Remission', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '11', 'groupId': 'OG006'}, {'value': '11', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}]}]}, {'title': 'Day 15: Remission', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '16', 'groupId': 'OG006'}, {'value': '13', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}]}]}, {'title': 'Day 22: Remission', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '15', 'groupId': 'OG006'}, {'value': '15', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}]}]}, {'title': 'Day 29: Remission', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '14', 'groupId': 'OG006'}, {'value': '15', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}]}]}, {'title': 'Day 34: Remission', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '12', 'groupId': 'OG006'}, {'value': '15', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}]}]}, {'title': 'Day 57: Remission', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '12', 'groupId': 'OG006'}, {'value': '12', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}]}]}, {'title': 'Day 71: Remission', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '12', 'groupId': 'OG006'}, {'value': '13', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day1 post-infusion (6 hours post start of infusion [SOI]), Day 1 (12 hours post SOI), Day2 (24 hours post SOI), Day 3 post-infusion (48 hours post SOI), Day 3 post-infusion (60 hours post SOI), Day 4 (72 hours post SOI), Days 8,11,15,22,29,34,57 and 71', 'description': 'HAMD17 Remission was defined as total score ≤7. The HAMD17 was a 17-item clinician-rated instrument used to assess the range of symptoms that were most frequently observed in participants with major depression. All items were scored on an ordinal scale between 0 and 4 (8 items) or 0 and 2 (9 items) of increasing severity. Each of 17 items was rated by clinician with rating of 0: absent, 1: doubtful to mild, 2: mild to moderate, 3: moderate to severe, and 4: very severe. A total score (0 to 52) was calculated by adding scores of all 17 items, where 0 indicated no depression and 52 indicated severe depression. Higher score represented more severe condition. Number of participants with HAMD17 remission is presented', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population. Only those participants with data available at the specified data points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Edinburgh Postnatal Depression Scale (EPDS) Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '17', 'groupId': 'OG006'}, {'value': '16', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Cohort 1', 'description': 'IV infusion of PBO at rate of 16 mL/h for 48 hours, then 8 mL/h for 12 hours'}, {'id': 'OG001', 'title': 'Ganaxolone Cohort 1', 'description': 'IV infusion of GNX at rate of 4 mg/h (16 mL/h) for 48 hours, then 2 mg/h for 12 hours'}, {'id': 'OG002', 'title': 'Placebo Cohort 2', 'description': 'IV infusion of PBO at rate of 16 mL/h for 48 hours, then 8 mL/h for 12 hours'}, {'id': 'OG003', 'title': 'Ganaxolone Cohort 2', 'description': 'IV infusion of GNX at rate of 8 mg/h for 48 hours, then 4 mg/h (8 mL/h) for 12 hours'}, {'id': 'OG004', 'title': 'Placebo Cohort 3', 'description': 'IV bolus of 24 mL PBO over 2 minutes; then 24 mL/h for 48 hours and then 12 mL/h for 12 hours'}, {'id': 'OG005', 'title': 'Ganaxolone Cohort 3', 'description': 'IV bolus of GNX 12 mg (24mL) over 2 min; then 12 mg/h (24mL/h) for 48hrs.'}, {'id': 'OG006', 'title': 'Placebo Cohort 6', 'description': 'IV infusion of PBO at rate of 40 mL/h for 6 hours; then 900 mg PBO (4 capsules) orally at dinner for 28 days'}, {'id': 'OG007', 'title': 'Ganaxolone Cohort 6', 'description': 'IV infusion of GNX at rate of 20 mg/h (40 mL/h) for 6 hours followed by 900 mg (4 capsules) orally at dinner for 28 days'}], 'classes': [{'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '17', 'groupId': 'OG006'}, {'value': '16', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '-1.9', 'spread': '2.87', 'groupId': 'OG006'}, {'value': '-5.4', 'spread': '6.61', 'groupId': 'OG007'}]}]}, {'title': 'Day 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '17', 'groupId': 'OG006'}, {'value': '16', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '-4.9', 'spread': '4.76', 'groupId': 'OG006'}, {'value': '-7.5', 'spread': '5.81', 'groupId': 'OG007'}]}]}, {'title': 'Day 3 post-infusion (60 hours post start of infusion)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '-8.8', 'spread': '14.64', 'groupId': 'OG000'}, {'value': '-8.0', 'spread': '8.63', 'groupId': 'OG001'}, {'value': '-10.8', 'spread': '6.66', 'groupId': 'OG002'}, {'value': '-10.8', 'spread': '6.32', 'groupId': 'OG003'}, {'value': '-12.2', 'spread': '6.21', 'groupId': 'OG004'}, {'value': '-10.9', 'spread': '6.06', 'groupId': 'OG005'}]}]}, {'title': 'Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '15', 'groupId': 'OG006'}, {'value': '16', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '-6.7', 'spread': '6.01', 'groupId': 'OG006'}, {'value': '-9.6', 'spread': '5.62', 'groupId': 'OG007'}]}]}, {'title': 'Day 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '-13.5', 'spread': '11.47', 'groupId': 'OG000'}, {'value': '-8.0', 'spread': '4.12', 'groupId': 'OG001'}, {'value': '-9.6', 'spread': '6.99', 'groupId': 'OG002'}, {'value': '-11.5', 'spread': '8.02', 'groupId': 'OG003'}, {'value': '-8.8', 'spread': '6.63', 'groupId': 'OG004'}, {'value': '-8.2', 'spread': '7.35', 'groupId': 'OG005'}]}]}, {'title': 'Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '17', 'groupId': 'OG006'}, {'value': '15', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '-8.0', 'spread': '6.02', 'groupId': 'OG006'}, {'value': '-11.3', 'spread': '5.06', 'groupId': 'OG007'}]}]}, {'title': 'Day 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '13', 'groupId': 'OG006'}, {'value': '15', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '-8.2', 'spread': '7.37', 'groupId': 'OG006'}, {'value': '-11.2', 'spread': '6.13', 'groupId': 'OG007'}]}]}, {'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '17', 'groupId': 'OG006'}, {'value': '16', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '-10.9', 'spread': '8.14', 'groupId': 'OG006'}, {'value': '-10.0', 'spread': '7.33', 'groupId': 'OG007'}]}]}, {'title': 'Day 34', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '-14.5', 'spread': '10.08', 'groupId': 'OG000'}, {'value': '-8.6', 'spread': '5.32', 'groupId': 'OG001'}, {'value': '-9.8', 'spread': '5.83', 'groupId': 'OG002'}, {'value': '-13.4', 'spread': '5.81', 'groupId': 'OG003'}, {'value': '-9.1', 'spread': '5.88', 'groupId': 'OG004'}, {'value': '-8.8', 'spread': '8.27', 'groupId': 'OG005'}]}]}, {'title': 'Day 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '12', 'groupId': 'OG006'}, {'value': '14', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '-11.8', 'spread': '6.57', 'groupId': 'OG006'}, {'value': '-12.4', 'spread': '6.57', 'groupId': 'OG007'}]}]}, {'title': 'Day 57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '12', 'groupId': 'OG006'}, {'value': '12', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '-11.8', 'spread': '6.79', 'groupId': 'OG006'}, {'value': '-9.4', 'spread': '8.50', 'groupId': 'OG007'}]}]}, {'title': 'Day 71', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '12', 'groupId': 'OG006'}, {'value': '13', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '-14.0', 'spread': '5.62', 'groupId': 'OG006'}, {'value': '-11.5', 'spread': '7.34', 'groupId': 'OG007'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 1, Day 2, Day 3 post-infusion (60 hours post start of infusion), Day 8, Day 11, Day 15, Day 22, Day 29, Day 34, Day 36, Day 57 and Day 71', 'description': 'The EPDS is a validated 10-question depression assessment for postpartum women, which includes anxiety symptoms and excludes constitutional symptoms associated with depression common in the postpartum period, such as changes in sleeping patterns. It consists of 10 multiple choice questions with scores for each question ranging from 0-3. Questions 1, 2, \\& 4 are scored 0, 1, 2 or 3 with top box scored as 0 and the bottom box scored as 3. Questions 3 and 5 to 10 are reverse scored, with the top box scored as a 3 and the bottom box scored as 0. Scores are then summed for a total score, which ranges from 0: no depression to 30: severe depression. Higher score indicates severe depression. Baseline was defined as the Day 1 assessment before study drug infusion. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population. Only those participants with data available at the specified data points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Spielberger State-Trait Anxiety Inventory 6-item Version (STAI6) Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '17', 'groupId': 'OG006'}, {'value': '16', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Cohort 1', 'description': 'IV infusion of PBO at rate of 16 mL/h for 48 hours, then 8 mL/h for 12 hours'}, {'id': 'OG001', 'title': 'Ganaxolone Cohort 1', 'description': 'IV infusion of GNX at rate of 4 mg/h (16 mL/h) for 48 hours, then 2 mg/h for 12 hours'}, {'id': 'OG002', 'title': 'Placebo Cohort 2', 'description': 'IV infusion of PBO at rate of 16 mL/h for 48 hours, then 8 mL/h for 12 hours'}, {'id': 'OG003', 'title': 'Ganaxolone Cohort 2', 'description': 'IV infusion of GNX at rate of 8 mg/h for 48 hours, then 4 mg/h (8 mL/h) for 12 hours'}, {'id': 'OG004', 'title': 'Placebo Cohort 3', 'description': 'IV bolus of 24 mL PBO over 2 minutes; then 24 mL/h for 48 hours and then 12 mL/h for 12 hours'}, {'id': 'OG005', 'title': 'Ganaxolone Cohort 3', 'description': 'IV bolus of GNX 12 mg (24mL) over 2 min; then 12 mg/h (24mL/h) for 48hrs.'}, {'id': 'OG006', 'title': 'Placebo Cohort 6', 'description': 'IV infusion of PBO at rate of 40 mL/h for 6 hours; then 900 mg PBO (4 capsules) orally at dinner for 28 days'}, {'id': 'OG007', 'title': 'Ganaxolone Cohort 6', 'description': 'IV infusion of GNX at rate of 20 mg/h (40 mL/h) for 6 hours followed by 900 mg (4 capsules) orally at dinner for 28 days'}], 'classes': [{'title': 'Day 1 (12 hours post start of infusion)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '17', 'groupId': 'OG006'}, {'value': '16', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '-8.9', 'spread': '20.09', 'groupId': 'OG000'}, {'value': '-4.2', 'spread': '13.44', 'groupId': 'OG001'}, {'value': '-14.5', 'spread': '14.48', 'groupId': 'OG002'}, {'value': '-12.01', 'spread': '11.25', 'groupId': 'OG003'}, {'value': '-10.7', 'spread': '10.52', 'groupId': 'OG004'}, {'value': '-11.3', 'spread': '19.51', 'groupId': 'OG005'}, {'value': '-9.4', 'spread': '14.78', 'groupId': 'OG006'}, {'value': '-17.7', 'spread': '20.28', 'groupId': 'OG007'}]}]}, {'title': 'Day 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '17', 'groupId': 'OG006'}, {'value': '16', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '-9.2', 'spread': '15.00', 'groupId': 'OG000'}, {'value': '-8.7', 'spread': '13.25', 'groupId': 'OG001'}, {'value': '-15.0', 'spread': '11.23', 'groupId': 'OG002'}, {'value': '-14.2', 'spread': '17.88', 'groupId': 'OG003'}, {'value': '-12.7', 'spread': '10.04', 'groupId': 'OG004'}, {'value': '-12.0', 'spread': '13.07', 'groupId': 'OG005'}, {'value': '-12.9', 'spread': '11.42', 'groupId': 'OG006'}, {'value': '-19.0', 'spread': '17.96', 'groupId': 'OG007'}]}]}, {'title': 'Day 3 post-infusion (60 hours post start of infusion)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '-11.7', 'spread': '33.39', 'groupId': 'OG000'}, {'value': '-22.0', 'spread': '18.65', 'groupId': 'OG001'}, {'value': '-18.2', 'spread': '12.95', 'groupId': 'OG002'}, {'value': '-21.0', 'spread': '16.46', 'groupId': 'OG003'}, {'value': '-24.3', 'spread': '16.11', 'groupId': 'OG004'}, {'value': '-24.0', 'spread': '15.85', 'groupId': 'OG005'}]}]}, {'title': 'Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '-20.0', 'spread': '23.73', 'groupId': 'OG000'}, {'value': '-20.7', 'spread': '19.78', 'groupId': 'OG001'}, {'value': '-21.0', 'spread': '13.77', 'groupId': 'OG002'}, {'value': '-22.9', 'spread': '17.14', 'groupId': 'OG003'}, {'value': '-25.0', 'spread': '13.99', 'groupId': 'OG004'}, {'value': '-22.3', 'spread': '17.78', 'groupId': 'OG005'}]}]}, {'title': 'Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '15', 'groupId': 'OG006'}, {'value': '16', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '-10.2', 'spread': '18.88', 'groupId': 'OG006'}, {'value': '-15.6', 'spread': '15.57', 'groupId': 'OG007'}]}]}, {'title': 'Day 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '-21.7', 'spread': '25.17', 'groupId': 'OG000'}, {'value': '-18.7', 'spread': '20.22', 'groupId': 'OG001'}, {'value': '-16.9', 'spread': '13.06', 'groupId': 'OG002'}, {'value': '-20.8', 'spread': '17.17', 'groupId': 'OG003'}, {'value': '-17.0', 'spread': '16.74', 'groupId': 'OG004'}, {'value': '-16.0', 'spread': '15.93', 'groupId': 'OG005'}]}]}, {'title': 'Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '16', 'groupId': 'OG006'}, {'value': '14', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '-12.3', 'spread': '20.39', 'groupId': 'OG006'}, {'value': '-17.4', 'spread': '19.00', 'groupId': 'OG007'}]}]}, {'title': 'Day 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '17', 'groupId': 'OG006'}, {'value': '15', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '-15.9', 'spread': '15.88', 'groupId': 'OG006'}, {'value': '-21.8', 'spread': '16.08', 'groupId': 'OG007'}]}]}, {'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '13', 'groupId': 'OG006'}, {'value': '15', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '-20.8', 'spread': '13.89', 'groupId': 'OG006'}, {'value': '-18.9', 'spread': '18.72', 'groupId': 'OG007'}]}]}, {'title': 'Day 34', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '-20.8', 'spread': '27.54', 'groupId': 'OG000'}, {'value': '-16.0', 'spread': '21.53', 'groupId': 'OG001'}, {'value': '-16.1', 'spread': '13.55', 'groupId': 'OG002'}, {'value': '-24.4', 'spread': '13.80', 'groupId': 'OG003'}, {'value': '-18.7', 'spread': '13.90', 'groupId': 'OG004'}, {'value': '-17.7', 'spread': '20.37', 'groupId': 'OG005'}]}]}, {'title': 'Day 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '12', 'groupId': 'OG006'}, {'value': '14', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '-21.9', 'spread': '9.69', 'groupId': 'OG006'}, {'value': '-21.7', 'spread': '19.07', 'groupId': 'OG007'}]}]}, {'title': 'Day 57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '12', 'groupId': 'OG006'}, {'value': '12', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '-21.7', 'spread': '12.67', 'groupId': 'OG006'}, {'value': '-13.3', 'spread': '25.23', 'groupId': 'OG007'}]}]}, {'title': 'Day 71', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '12', 'groupId': 'OG006'}, {'value': '13', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '-31.7', 'spread': '16.97', 'groupId': 'OG006'}, {'value': '-21.0', 'spread': '16.91', 'groupId': 'OG007'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 1 (12 hours post start of infusion), Day 2, Day 3 post-infusion (60 hours post start of infusion), Day 4, Day 8, Day 11, Day 15, Day 22, Day 29, Day 34, Day 36, Day 57 and Day 71', 'description': 'The STAI6 is a 6-item self-rated instrument used to assess anxiety state. The STAI6 questions included: 1. "I feel calm"; 2. "I am tense"; 3. "I feel upset"; 4. "I am relaxed"; 5. "I feel content"; 6. "I am worried". Each of these questions were rated as: a) "not at all"; b) "somewhat"; c) "moderately"; d) "very much". For questions 2, 3, and 6, the scoring was a = 1, b = 2, c = 3, and d = 4. For the other 3 questions, the scoring was a = 4, b = 3, c = 2, and d = 1. The STAI6 score was the result of first totaling the 6 individual item scores, and then prorating by a multiplication factor of 20/6 to acquire a score range of 20 (low anxiety) to 80 (high anxiety). Higher score indicated higher level of anxiety. Baseline was defined as the Day 1 assessment before study drug infusion. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population. Only those participants with data available at the specified data points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Response to Clinical Global Impression-Improvement (CGI-I) Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '17', 'groupId': 'OG006'}, {'value': '16', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Cohort 1', 'description': 'IV infusion of PBO at rate of 16 mL/h for 48 hours, then 8 mL/h for 12 hours'}, {'id': 'OG001', 'title': 'Ganaxolone Cohort 1', 'description': 'IV infusion of GNX at rate of 4 mg/h (16 mL/h) for 48 hours, then 2 mg/h for 12 hours'}, {'id': 'OG002', 'title': 'Placebo Cohort 2', 'description': 'IV infusion of PBO at rate of 16 mL/h for 48 hours, then 8 mL/h for 12 hours'}, {'id': 'OG003', 'title': 'Ganaxolone Cohort 2', 'description': 'IV infusion of GNX at rate of 8 mg/h for 48 hours, then 4 mg/h (8 mL/h) for 12 hours'}, {'id': 'OG004', 'title': 'Placebo Cohort 3', 'description': 'IV bolus of 24 mL PBO over 2 minutes; then 24 mL/h for 48 hours and then 12 mL/h for 12 hours'}, {'id': 'OG005', 'title': 'Ganaxolone Cohort 3', 'description': 'IV bolus of GNX 12 mg (24mL) over 2 min; then 12 mg/h (24mL/h) for 48hrs.'}, {'id': 'OG006', 'title': 'Placebo Cohort 6', 'description': 'IV infusion of PBO at rate of 40 mL/h for 6 hours; then 900 mg PBO (4 capsules) orally at dinner for 28 days'}, {'id': 'OG007', 'title': 'Ganaxolone Cohort 6', 'description': 'IV infusion of GNX at rate of 20 mg/h (40 mL/h) for 6 hours followed by 900 mg (4 capsules) orally at dinner for 28 days'}], 'classes': [{'title': 'Day 1 (12 hours post start of infusion): Very much or much improved', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '17', 'groupId': 'OG006'}, {'value': '16', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '7', 'groupId': 'OG007'}]}]}, {'title': 'Day 1 (12 hours post start of infusion): Minimally or not improved', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '17', 'groupId': 'OG006'}, {'value': '16', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '14', 'groupId': 'OG006'}, {'value': '9', 'groupId': 'OG007'}]}]}, {'title': 'Day 2: Very much or much improved', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '17', 'groupId': 'OG006'}, {'value': '16', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '9', 'groupId': 'OG007'}]}]}, {'title': 'Day 2: Minimally or not improved', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '17', 'groupId': 'OG006'}, {'value': '16', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}, {'value': '14', 'groupId': 'OG006'}, {'value': '7', 'groupId': 'OG007'}]}]}, {'title': 'Day 3 post-infusion (60 hours post start of infusion): Very much or much improved', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}]}]}, {'title': 'Day 3 post-infusion (60 hours post start of infusion): Minimally or not improved', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}]}, {'title': 'Day 4: Very much or much improved', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}]}]}, {'title': 'Day 4: Minimally or not improved', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}]}, {'title': 'Day 8: Very much or much improved', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '15', 'groupId': 'OG006'}, {'value': '15', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG006'}, {'value': '9', 'groupId': 'OG007'}]}]}, {'title': 'Day 8: Minimally or not improved', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '15', 'groupId': 'OG006'}, {'value': '15', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}]}]}, {'title': 'Day 11: Very much or much improved', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}]}, {'title': 'Day 11: Minimally or not improved', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}]}, {'title': 'Day 15: Very much or much improved', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '16', 'groupId': 'OG006'}, {'value': '15', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG006'}, {'value': '13', 'groupId': 'OG007'}]}]}, {'title': 'Day 15: Minimally or not improved', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '16', 'groupId': 'OG006'}, {'value': '15', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}]}]}, {'title': 'Day 22: Very much or much improved', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '15', 'groupId': 'OG006'}, {'value': '15', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}]}]}, {'title': 'Day 22: Minimally or not improved', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '15', 'groupId': 'OG006'}, {'value': '15', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}]}]}, {'title': 'Day 29: Very much or much improved', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '16', 'groupId': 'OG006'}, {'value': '16', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG006'}, {'value': '12', 'groupId': 'OG007'}]}]}, {'title': 'Day 29: Minimally or not improved', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '16', 'groupId': 'OG006'}, {'value': '16', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}]}]}, {'title': 'Day 34: Very much or much improved', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}]}, {'title': 'Day 34: Minimally or not improved', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}]}, {'title': 'Day 36: Very much or much improved', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '12', 'groupId': 'OG006'}, {'value': '14', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG006'}, {'value': '11', 'groupId': 'OG007'}]}]}, {'title': 'Day 36: Minimally or not improved', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '12', 'groupId': 'OG006'}, {'value': '14', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}]}]}, {'title': 'Day 57: Very much or much improved', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '12', 'groupId': 'OG006'}, {'value': '12', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG006'}, {'value': '8', 'groupId': 'OG007'}]}]}, {'title': 'Day 57: Minimally or not improved', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '12', 'groupId': 'OG006'}, {'value': '12', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}]}]}, {'title': 'Day 71: Very much or much improved', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '12', 'groupId': 'OG006'}, {'value': '13', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}]}]}, {'title': 'Day 71: Minimally or not improved', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '12', 'groupId': 'OG006'}, {'value': '13', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 (12 hours post start of infusion), Day 2, Day 3 post-infusion (60 hours post start of infusion), Day 4, Day 8, Day 11, Day 15, Day 22, Day 29, Day 34, Day 36, Day 57 and Day 71', 'description': 'The CGI-I scale is a clinician-rated 7-point scale used to assess how much the participant\'s illness had improved or worsened relative to a Baseline state at the beginning of the intervention. It was rated as: 1. "very much improved"; 2. "much improved"; 3. "minimally improved"; 4. "no change"; 5. "minimally worse"; 6. "much worse"; 7. "very much worse". Higher scores indicated worse condition. Response was defined as \\>50% decrease from Baseline in CGI-I total score.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population. Only those participants with data available at the specified data points were analyzed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo Cohort 1', 'description': 'Intravenous (IV) infusion of placebo (PBO) at rate of 16 milliliter per hour (mL/h) for 48 hours, then 8 mL/h for 12 hours'}, {'id': 'FG001', 'title': 'Ganaxolone Cohort 1', 'description': 'IV infusion of ganaxolone (GNX) at rate of 4 milligram per hour (mg/h) (16 mL/h) for 48 hours, then 2 mg/h for 12 hours'}, {'id': 'FG002', 'title': 'Placebo Cohort 2', 'description': 'IV infusion of PBO at rate of 16 mL/h for 48 hours, then 8 mL/h for 12 hours.'}, {'id': 'FG003', 'title': 'Ganaxolone Cohort 2', 'description': 'IV infusion of GNX at rate of 8 mg/h for 48 hours, then 4 mg/h (8 mL/h) for 12 hours'}, {'id': 'FG004', 'title': 'Placebo Cohort 3', 'description': 'IV bolus of 24 mL PBO over 2 minutes; then 24 mL for 48 hours and then 12 mL/h for 12 hours.'}, {'id': 'FG005', 'title': 'Ganaxolone Cohort 3', 'description': 'IV bolus of 12 mg (24mL) GNX over 2 minutes; then GNX at 12 mg/h (24 mL/h) for 48 hours and then 6 mg/h (12 mL/h) for 12 hours.'}, {'id': 'FG006', 'title': 'Placebo Cohort 6', 'description': 'IV infusion of PBO at rate of 40 mL/h for 6 hours; then 900 mg PBO (4 capsules) orally at dinner for 28 days'}, {'id': 'FG007', 'title': 'Ganaxolone Cohort 6', 'description': 'IV infusion of GNX at rate of 20 mg/h (40 mL/h) for 6 hours followed by 900 mg (4 capsules) orally at dinner for 28 days'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '14'}, {'groupId': 'FG003', 'numSubjects': '15'}, {'groupId': 'FG004', 'numSubjects': '10'}, {'groupId': 'FG005', 'numSubjects': '10'}, {'groupId': 'FG006', 'numSubjects': '17'}, {'groupId': 'FG007', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '12'}, {'groupId': 'FG003', 'numSubjects': '13'}, {'groupId': 'FG004', 'numSubjects': '10'}, {'groupId': 'FG005', 'numSubjects': '10'}, {'groupId': 'FG006', 'numSubjects': '12'}, {'groupId': 'FG007', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '5'}, {'groupId': 'FG007', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '2'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '3'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Noncompliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}, {'value': '10', 'groupId': 'BG005'}, {'value': '17', 'groupId': 'BG006'}, {'value': '16', 'groupId': 'BG007'}, {'value': '91', 'groupId': 'BG008'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo Cohort 1', 'description': 'IV infusion of PBO at rate of 16 mL/h for 48 hours, then 8 mL/h for 12 hours'}, {'id': 'BG001', 'title': 'Ganaxolone Cohort 1', 'description': 'IV infusion of GNX at rate of 4 mg/h (16 mL/h) for 48 hours, then 2 mg/h for 12 hours'}, {'id': 'BG002', 'title': 'Placebo Cohort 2', 'description': 'IV infusion of PBO at rate of 16 mL/h for 48 hours, then 8 mL/h for 12 hours'}, {'id': 'BG003', 'title': 'Ganaxolone Cohort 2', 'description': 'IV infusion of GNX at rate of 8 mg/h for 48 hours, then 4 mg/h (8 mL/h) for 12 hours'}, {'id': 'BG004', 'title': 'Placebo Cohort 3', 'description': 'IV bolus of 24 mL PBO over 2 minutes; then 24 mL/h for 48 hours and then 12 mL/h for 12 hours'}, {'id': 'BG005', 'title': 'Ganaxolone Cohort 3', 'description': 'IV bolus of 12 mg (24mL) GNX over 2 minutes; then GNX at 12 mg/h (24 mL/h) for 48 hours and then 6 mg/h (12 mL/h) for 12 hours'}, {'id': 'BG006', 'title': 'Placebo Cohort 6', 'description': 'IV infusion of PBO at rate of 40 mL/h for 6 hours; then 900 mg PBO (4 capsules) orally at dinner for 28 days'}, {'id': 'BG007', 'title': 'Ganaxolone Cohort 6', 'description': 'IV infusion of GNX at rate of 20 mg/h (40 mL/h) for 6 hours followed by 900 mg (4 capsules) orally at dinner for 28 days'}, {'id': 'BG008', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '25.3', 'spread': '2.22', 'groupId': 'BG000'}, {'value': '24.4', 'spread': '6.27', 'groupId': 'BG001'}, {'value': '26.4', 'spread': '6.02', 'groupId': 'BG002'}, {'value': '27.0', 'spread': '7.11', 'groupId': 'BG003'}, {'value': '26.4', 'spread': '5.70', 'groupId': 'BG004'}, {'value': '25.0', 'spread': '4.11', 'groupId': 'BG005'}, {'value': '24.9', 'spread': '5.10', 'groupId': 'BG006'}, {'value': '28.8', 'spread': '4.97', 'groupId': 'BG007'}, {'value': '26.30', 'spread': '3.495', 'groupId': 'BG008'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}, {'value': '10', 'groupId': 'BG005'}, {'value': '17', 'groupId': 'BG006'}, {'value': '16', 'groupId': 'BG007'}, {'value': '91', 'groupId': 'BG008'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}, {'value': '7', 'groupId': 'BG008'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}, {'value': '9', 'groupId': 'BG005'}, {'value': '17', 'groupId': 'BG006'}, {'value': '14', 'groupId': 'BG007'}, {'value': '84', 'groupId': 'BG008'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}]}]}], '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': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '2', 'groupId': 'BG008'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}, {'value': '8', 'groupId': 'BG005'}, {'value': '12', 'groupId': 'BG006'}, {'value': '8', 'groupId': 'BG007'}, {'value': '56', 'groupId': 'BG008'}]}, {'title': 'White', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '4', 'groupId': 'BG006'}, {'value': '8', 'groupId': 'BG007'}, {'value': '30', 'groupId': 'BG008'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '2', 'groupId': 'BG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-10-08', 'size': 4653533, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_002.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-07-04T10:55', 'hasProtocol': True}, {'date': '2019-06-07', 'size': 7692730, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_003.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-07-04T10:57', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 91}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'dispFirstSubmitDate': '2020-09-02', 'completionDateStruct': {'date': '2020-05-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-04', 'studyFirstSubmitDate': '2017-07-05', 'dispFirstSubmitQcDate': '2023-01-13', 'resultsFirstSubmitDate': '2022-05-24', 'studyFirstSubmitQcDate': '2017-07-20', 'dispFirstPostDateStruct': {'date': '2023-02-08', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2023-07-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-01-13', 'studyFirstPostDateStruct': {'date': '2017-07-24', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-02-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Hamilton Depression Rating Scale 17-item Version (HAMD17) Total Score', 'timeFrame': 'Baseline and Day 3 post-infusion (60 hours post start of infusion) for Cohorts 1 to 3 and Baseline and Day 29 for Cohort 6', 'description': 'The HAMD17 was a 17-item clinician-rated instrument used to assess the range of symptoms that were most frequently observed in participants with major depression. All items were scored on an ordinal scale between 0 and 4 (8 items) or 0 and 2 (9 items) of increasing severity. Each of 17 items was rated by clinician with rating of 0: absent, 1: doubtful to mild, 2: mild to moderate, 3: moderate to severe, and 4: very severe. A total score (0 to 52) was calculated by adding scores of all 17 items, where 0 indicated no depression and 52 indicated severe depression. Higher score represented more severe condition. Baseline was defined as the Day 1 assessment before study drug infusion. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in HAMD17 Total Score at Indicated Time Points', 'timeFrame': 'Baseline, Day1 post-infusion(6hours post start of infusion), Day1(12hours post start of infusion), Day2(24hours post start of infusion),Day3 post-infusion(48hours post start of infusion),Day4(72hours post start of infusion),Days 8,11,15,22,36,57 and 71', 'description': 'The HAMD17 was a 17-item clinician-rated instrument used to assess the range of symptoms that were most frequently observed in participants with major depression. All items were scored on an ordinal scale between 0 and 4 (8 items) or 0 and 2 (9 items) of increasing severity. Each of 17 items was rated by clinician with rating of 0: absent, 1: doubtful to mild, 2: mild to moderate, 3: moderate to severe, and 4: very severe. A total score (0 to 52) was calculated by adding scores of all 17 items, where 0 indicated no depression and 52 indicated severe depression. Higher score represented more severe condition. Baseline was defined as the Day 1 assessment before study drug infusion. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.'}, {'measure': 'Number of Participants With HAMD17 Response', 'timeFrame': 'Day1 post-infusion (6 hours post start of infusion [SOI]), Day 1 (12 hours post SOI), Day 2 (24 hours post SOI),Day 3 post-infusion (48 hours post SOI), Day 3 post-infusion (60 hours post SOI), Day 4 (72 hours post SOI), Days 8,11,15,22,29,36,57 and 71', 'description': 'HAMD17 Response was defined as ≥50% reduction from Baseline in total score. The HAMD17 was a 17-item clinician-rated instrument used to assess the range of symptoms that were most frequently observed in participants with major depression. All items were scored on an ordinal scale between 0 and 4 (8 items) or 0 and 2 (9 items) of increasing severity. Each of 17 items was rated by clinician with rating of 0: absent, 1: doubtful to mild, 2: mild to moderate, 3: moderate to severe, and 4: very severe. A total score (0 to 52) was calculated by adding scores of all 17 items, where 0 indicated no depression and 52 indicated severe depression. Higher score represented more severe condition. Number of participants with HAMD17 response is presented.'}, {'measure': 'Number of Participants With HAMD17 Remission', 'timeFrame': 'Day1 post-infusion (6 hours post start of infusion [SOI]), Day 1 (12 hours post SOI), Day2 (24 hours post SOI), Day 3 post-infusion (48 hours post SOI), Day 3 post-infusion (60 hours post SOI), Day 4 (72 hours post SOI), Days 8,11,15,22,29,34,57 and 71', 'description': 'HAMD17 Remission was defined as total score ≤7. The HAMD17 was a 17-item clinician-rated instrument used to assess the range of symptoms that were most frequently observed in participants with major depression. All items were scored on an ordinal scale between 0 and 4 (8 items) or 0 and 2 (9 items) of increasing severity. Each of 17 items was rated by clinician with rating of 0: absent, 1: doubtful to mild, 2: mild to moderate, 3: moderate to severe, and 4: very severe. A total score (0 to 52) was calculated by adding scores of all 17 items, where 0 indicated no depression and 52 indicated severe depression. Higher score represented more severe condition. Number of participants with HAMD17 remission is presented'}, {'measure': 'Change From Baseline in Edinburgh Postnatal Depression Scale (EPDS) Total Score', 'timeFrame': 'Baseline, Day 1, Day 2, Day 3 post-infusion (60 hours post start of infusion), Day 8, Day 11, Day 15, Day 22, Day 29, Day 34, Day 36, Day 57 and Day 71', 'description': 'The EPDS is a validated 10-question depression assessment for postpartum women, which includes anxiety symptoms and excludes constitutional symptoms associated with depression common in the postpartum period, such as changes in sleeping patterns. It consists of 10 multiple choice questions with scores for each question ranging from 0-3. Questions 1, 2, \\& 4 are scored 0, 1, 2 or 3 with top box scored as 0 and the bottom box scored as 3. Questions 3 and 5 to 10 are reverse scored, with the top box scored as a 3 and the bottom box scored as 0. Scores are then summed for a total score, which ranges from 0: no depression to 30: severe depression. Higher score indicates severe depression. Baseline was defined as the Day 1 assessment before study drug infusion. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.'}, {'measure': 'Change From Baseline in Spielberger State-Trait Anxiety Inventory 6-item Version (STAI6) Total Score', 'timeFrame': 'Baseline, Day 1 (12 hours post start of infusion), Day 2, Day 3 post-infusion (60 hours post start of infusion), Day 4, Day 8, Day 11, Day 15, Day 22, Day 29, Day 34, Day 36, Day 57 and Day 71', 'description': 'The STAI6 is a 6-item self-rated instrument used to assess anxiety state. The STAI6 questions included: 1. "I feel calm"; 2. "I am tense"; 3. "I feel upset"; 4. "I am relaxed"; 5. "I feel content"; 6. "I am worried". Each of these questions were rated as: a) "not at all"; b) "somewhat"; c) "moderately"; d) "very much". For questions 2, 3, and 6, the scoring was a = 1, b = 2, c = 3, and d = 4. For the other 3 questions, the scoring was a = 4, b = 3, c = 2, and d = 1. The STAI6 score was the result of first totaling the 6 individual item scores, and then prorating by a multiplication factor of 20/6 to acquire a score range of 20 (low anxiety) to 80 (high anxiety). Higher score indicated higher level of anxiety. Baseline was defined as the Day 1 assessment before study drug infusion. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.'}, {'measure': 'Number of Participants With Response to Clinical Global Impression-Improvement (CGI-I) Scale', 'timeFrame': 'Day 1 (12 hours post start of infusion), Day 2, Day 3 post-infusion (60 hours post start of infusion), Day 4, Day 8, Day 11, Day 15, Day 22, Day 29, Day 34, Day 36, Day 57 and Day 71', 'description': 'The CGI-I scale is a clinician-rated 7-point scale used to assess how much the participant\'s illness had improved or worsened relative to a Baseline state at the beginning of the intervention. It was rated as: 1. "very much improved"; 2. "much improved"; 3. "minimally improved"; 4. "no change"; 5. "minimally worse"; 6. "much worse"; 7. "very much worse". Higher scores indicated worse condition. Response was defined as \\>50% decrease from Baseline in CGI-I total score.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Postpartum Care', 'Postpartum Depression'], 'conditions': ['Depression', 'Depressive Disorder', 'Depression, Postpartum', 'Behavioral Symptoms', 'Mood Disorders', 'Mental Disorders', 'Puerperal Disorders', 'Pregnancy Complications', 'Postpartum', 'PPD']}, 'descriptionModule': {'briefSummary': 'This study will evaluate the Safety, Pharmacokinetics and Efficacy of IV Administration of Ganaxolone in Women with Postpartum Depression', 'detailedDescription': "This study will explore whether ganaxolone is safe and well tolerated in women suffering from PPD. In addition, ganaxolone's efficacy in treating depressive symptoms will be assessed through a set of exploratory analyses. Plasma levels of ganaxolone will be determined through pharmacokinetic analysis. The study results will be used to select a ganaxolone dose and dosing regimen for further development in PPD."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Women with postpartum depression', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participant experienced a Major Depressive Episode, which started between the start of the third trimester and 4 weeks following delivery. The Major Depressive Episode must be diagnosed according to Mini International Neuropsychiatric Interview (MINI) 7.0 interview\n* Participant gave birth in the last 6 months\n* Participant has a Hamilton Depression Rating Scale 17-item version (HAMD17) score of ≥ 26 at screening\n* Participant must agree to stop breastfeeding from start of study treatment or must agree to temporarily cease giving breast milk to her infant(s)\n\nExclusion Criteria:\n\n* Current or past history of any psychotic illness, including Major Depressive Episode with psychotic features\n* History of suicide attempt within the past 3 years\n* Active suicidal ideation\n* History of bipolar I disorder\n* History of seizure disorder'}, 'identificationModule': {'nctId': 'NCT03228394', 'briefTitle': 'A Clinical Trial of Intravenous (IV) Ganaxolone in Women With Postpartum Depression', 'organization': {'class': 'INDUSTRY', 'fullName': 'Marinus Pharmaceuticals'}, 'officialTitle': 'A Phase 2A, Double-blind, Placebo-controlled, Multiple-dose Escalation Study to Evaluate Safety, Pharmacokinetics and Efficacy of Intravenously Administered Ganaxolone in Women With Postpartum Depression', 'orgStudyIdInfo': {'id': '1042-PPD-2002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ganaxolone', 'description': 'Intravenous', 'interventionNames': ['Drug: Ganaxolone']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Intravenous', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Ganaxolone', 'type': 'DRUG', 'description': 'Ganaxolone IV', 'armGroupLabels': ['Ganaxolone']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo IV', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72211', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Marinus Research Site', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '92626', 'city': 'Costa Mesa', 'state': 'California', 'country': 'United States', 'facility': 'Marinus Research Site', 'geoPoint': {'lat': 33.64113, 'lon': -117.91867}}, {'zip': '91945', 'city': 'Lemon Grove', 'state': 'California', 'country': 'United States', 'facility': 'Marinus Research Site', 'geoPoint': {'lat': 32.74255, 'lon': -117.03142}}, {'zip': '92103', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Marinus Research Site', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '32216', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Marinus Research Site', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '30331', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Marinus Research Site', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30030', 'city': 'Decatur', 'state': 'Georgia', 'country': 'United States', 'facility': 'Marinus Research Site', 'geoPoint': {'lat': 33.77483, 'lon': -84.29631}}, {'zip': '66206', 'city': 'Leawood', 'state': 'Kansas', 'country': 'United States', 'facility': 'Marinus Research Site', 'geoPoint': {'lat': 38.96667, 'lon': -94.6169}}, {'zip': '66211', 'city': 'Overland Park', 'state': 'Kansas', 'country': 'United States', 'facility': 'Marinus Research Site', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Marinus Research Site', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '45417', 'city': 'Dayton', 'state': 'Ohio', 'country': 'United States', 'facility': 'Marinus Research Site', 'geoPoint': {'lat': 39.75895, 'lon': -84.19161}}, {'zip': '77058', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Marinus Research Site', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '75062', 'city': 'Irving', 'state': 'Texas', 'country': 'United States', 'facility': 'Marinus Research Site', 'geoPoint': {'lat': 32.81402, 'lon': -96.94889}}, {'zip': '84058', 'city': 'Orem', 'state': 'Utah', 'country': 'United States', 'facility': 'Marinus Research Site', 'geoPoint': {'lat': 40.2969, 'lon': -111.69465}}, {'zip': '84124', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Marinus Research Site', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '23298', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Marinus Research Site', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Marinus Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}