Ignite Creation Date:
2025-12-24 @ 3:21 PM
Ignite Modification Date:
2026-01-06 @ 3:33 PM
Study NCT ID:
NCT04011592
Status:
TERMINATED
Last Update Posted:
2021-10-19
First Post:
2019-07-03
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy And Tolerability Of Sub-Anesthetic Ketamine In Postpartum Depression
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019052', 'term': 'Depression, Postpartum'}], 'ancestors': [{'id': 'D011644', 'term': 'Puerperal Disorders'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007649', 'term': 'Ketamine'}], 'ancestors': [{'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Sudhakar.Selvaraj@uth.tmc.edu', 'phone': '713-486-2837', 'title': 'Sudhakar Selvaraj, MD, PhD, Assistant Professor', 'organization': 'The University of Texas Health Science Center at Houston'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Only one subject was enrolled, and enrollment goal not met.'}}, 'adverseEventsModule': {'timeFrame': '24 hours', 'eventGroups': [{'id': 'EG000', 'title': 'Ketamine 0.5 mg/kg', 'description': 'Ketamine 0.5 mg/kg: single intravenous infusion of Ketamine (0.5 mg/kg)', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 1, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Ketamine 0.2 mg/kg', 'description': 'Ketamine 0.2 mg/kg: single intravenous infusion of Ketamine (0.2 mg/kg)', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 1, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Mild headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Moderate Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Depressed Mood as Indicated by Hamilton Depression Rating Scale (HAM-D) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ketamine 0.5 mg/kg', 'description': 'Ketamine 0.5 mg/kg: single intravenous infusion of Ketamine (0.5 mg/kg)'}, {'id': 'OG001', 'title': 'Ketamine 0.2 mg/kg', 'description': 'Ketamine 0.2 mg/kg: single intravenous infusion of Ketamine (0.2 mg/kg)'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'spread': 'NA', 'comment': 'Standard Deviation is not calculable for 1 participant.', 'groupId': 'OG000'}, {'value': '3', 'spread': 'NA', 'comment': 'Standard Deviation is not calculable for 1 participant.', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 24 hours post-injection', 'description': 'The Hamilton Depression Rating Scale (HAM-D) score ranges from 0-53. A score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates at least moderate severity of depressive symptoms. The value reported is the score at baseline minus the score 24 hours post-injection.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Treatment-Emergent Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ketamine 0.5 mg/kg', 'description': 'Ketamine 0.5 mg/kg: single intravenous infusion of Ketamine (0.5 mg/kg)'}, {'id': 'OG001', 'title': 'Ketamine 0.2 mg/kg', 'description': 'Ketamine 0.2 mg/kg: single intravenous infusion of Ketamine (0.2 mg/kg)'}], 'classes': [{'title': 'mild headache', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'moderate nausea', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 hours post-injection', 'unitOfMeasure': 'adverse events', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Postnatal Depression as Indicated by Edinburgh Postnatal Depression Scale (EPDS) Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ketamine 0.5 mg/kg', 'description': 'Ketamine 0.5 mg/kg: single intravenous infusion of Ketamine (0.5 mg/kg)'}, {'id': 'OG001', 'title': 'Ketamine 0.2 mg/kg', 'description': 'Ketamine 0.2 mg/kg: single intravenous infusion of Ketamine (0.2 mg/kg)'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'spread': 'NA', 'comment': 'Standard Deviation is not calculable for 1 participant.', 'groupId': 'OG000'}, {'value': '2', 'spread': 'NA', 'comment': 'Standard Deviation is not calculable for 1 participant.', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 24 hours post-injection', 'description': 'The Edinburgh Postnatal Depression Scale (EPDS) score ranges from 0 to 30. Higher scores indicate worse outcome, with a score of 10 or greater indicating depression. The value reported is the score at baseline minus the score at 24 hours post-injection.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Anxiety as Indicated by Generalized Anxiety Disorder 7-Item (GAD-7) Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ketamine 0.5 mg/kg', 'description': 'Ketamine 0.5 mg/kg: single intravenous infusion of Ketamine (0.5 mg/kg)'}, {'id': 'OG001', 'title': 'Ketamine 0.2 mg/kg', 'description': 'Ketamine 0.2 mg/kg: single intravenous infusion of Ketamine (0.2 mg/kg)'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'spread': 'NA', 'comment': 'Standard Deviation is not calculable for 1 participant.', 'groupId': 'OG000'}, {'value': '0', 'spread': 'NA', 'comment': 'Standard Deviation is not calculable for 1 participant.', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 24 hours post-injection', 'description': 'The Generalized Anxiety Disorder 7-Item (GAD-7) Scale score ranges from 0 to 21, with higher scores indicating greater anxiety. The value reported is the score at baseline minus the score 24 hours post-injection.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Depression as Indicated by Patient Health Questionnaire (PHQ-9)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ketamine 0.5 mg/kg', 'description': 'Ketamine 0.5 mg/kg: single intravenous infusion of Ketamine (0.5 mg/kg)'}, {'id': 'OG001', 'title': 'Ketamine 0.2 mg/kg', 'description': 'Ketamine 0.2 mg/kg: single intravenous infusion of Ketamine (0.2 mg/kg)'}], 'timeFrame': 'baseline, 24 hours post-injection', 'description': 'The Patient Health Questionnaire (PHQ-9) score ranges from 0 to 27, with greater scores indicating more severe depression.', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome measure was not assessed and no data were collected.'}, {'type': 'SECONDARY', 'title': 'Change in Behavioral Suicidal Events (Suicidal Ideation), as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ketamine 0.5 mg/kg', 'description': 'Ketamine 0.5 mg/kg: single intravenous infusion of Ketamine (0.5 mg/kg)'}, {'id': 'OG001', 'title': 'Ketamine 0.2 mg/kg', 'description': 'Ketamine 0.2 mg/kg: single intravenous infusion of Ketamine (0.2 mg/kg)'}], 'timeFrame': 'baseline, 24 hours post-injection', 'description': 'The C-SSRS is a suicidal ideation and behavior rating scale with yes/no responses. The first part (Items 1-5) rates an individual\'s degree of suicidal ideation on a 0-5 scale, ranging from "wish to be dead" to "active suicidal ideation with specific plan and intent and behaviors". The C-SSRS outcomes are categories and have binary responses (yes/no). Suicidal ideation is considered when the patient responds a "yes" answer at any time during treatment to any one of the five suicidal ideation questions (Categories 1-5) on the C-SSRS. The sum of the 5 intensity item scores create a total score (range 0 to 25) to represent the intensity rating (higher scores indicate more severe suicidal ideation).', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome measure was not assessed and no data were collected.'}, {'type': 'SECONDARY', 'title': 'Change in Behavioral Suicidal Events (Suicidal Behavior), as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ketamine 0.5 mg/kg', 'description': 'Ketamine 0.5 mg/kg: single intravenous infusion of Ketamine (0.5 mg/kg)'}, {'id': 'OG001', 'title': 'Ketamine 0.2 mg/kg', 'description': 'Ketamine 0.2 mg/kg: single intravenous infusion of Ketamine (0.2 mg/kg)'}], 'timeFrame': 'baseline, 24 hours post-injection', 'description': 'The questions 6-10 of the C-SSRS are related to suicidal behavior, and the outcome is a simple yes/no response. Suicidal behavior occurs if the patient answers a "yes" at any time during treatment to any one of the five suicidal behavior questions (Categories 6-10) on the C-SSRS.', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome measure was not assessed and no data were collected.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ketamine 0.5 mg/kg, Then Ketamine 0.2 mg/kg', 'description': 'single intravenous infusion of Ketamine (0.5 mg/kg), washout period of seven days, and then single intravenous infusion of Ketamine (0.2 mg/kg)\n\nKetamine 0.5 mg/kg: single intravenous infusion of Ketamine (0.5 mg/kg)\n\nKetamine 0.2 mg/kg: single intravenous infusion of Ketamine (0.2 mg/kg)'}, {'id': 'FG001', 'title': 'Ketamine 0.2 mg/kg, Then Ketamine 0.5 mg/kg', 'description': 'single intravenous infusion of Ketamine (0.2 mg/kg), washout period of seven days, and then single intravenous infusion of Ketamine (0.5 mg/kg)\n\nKetamine 0.5 mg/kg: single intravenous infusion of Ketamine (0.5 mg/kg)\n\nKetamine 0.2 mg/kg: single intravenous infusion of Ketamine (0.2 mg/kg)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Ketamine 0.5 mg/kg, Then Ketamine 0.2 mg/kg', 'description': 'single intravenous infusion of Ketamine (0.5 mg/kg), washout period of seven days, and then single intravenous infusion of Ketamine (0.2 mg/kg)\n\nKetamine 0.5 mg/kg: single intravenous infusion of Ketamine (0.5 mg/kg)\n\nKetamine 0.2 mg/kg: single intravenous infusion of Ketamine (0.2 mg/kg)'}, {'id': 'BG001', 'title': 'Ketamine 0.2 mg/kg, Then Ketamine 0.5 mg/kg', 'description': 'single intravenous infusion of Ketamine (0.2 mg/kg), washout period of seven days, and then single intravenous infusion of Ketamine (0.5 mg/kg)\n\nKetamine 0.5 mg/kg: single intravenous infusion of Ketamine (0.5 mg/kg)\n\nKetamine 0.2 mg/kg: single intravenous infusion of Ketamine (0.2 mg/kg)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '37', 'spread': 'NA', 'comment': 'Standard Deviation is not calculable for 1 participant.', 'groupId': 'BG000'}, {'value': '37', 'spread': 'NA', 'comment': 'Standard Deviation is not calculable for 1 participant.', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], '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'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Only one participant was enrolled, and this participant received 0.5 mg/kg Ketamine, then 0.2 mg/kg Ketamine.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-06-26', 'size': 969215, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-08-24T19:19', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}}, 'statusModule': {'whyStopped': 'Recruitment not feasible', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-03-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2019-09-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-29', 'studyFirstSubmitDate': '2019-07-03', 'resultsFirstSubmitDate': '2020-08-24', 'studyFirstSubmitQcDate': '2019-07-03', 'lastUpdatePostDateStruct': {'date': '2021-10-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-08-24', 'studyFirstPostDateStruct': {'date': '2019-07-08', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-09-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Depressed Mood as Indicated by Hamilton Depression Rating Scale (HAM-D) Score', 'timeFrame': 'baseline, 24 hours post-injection', 'description': 'The Hamilton Depression Rating Scale (HAM-D) score ranges from 0-53. A score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates at least moderate severity of depressive symptoms. The value reported is the score at baseline minus the score 24 hours post-injection.'}], 'secondaryOutcomes': [{'measure': 'Number of Treatment-Emergent Adverse Events', 'timeFrame': '24 hours post-injection'}, {'measure': 'Change in Postnatal Depression as Indicated by Edinburgh Postnatal Depression Scale (EPDS) Scale', 'timeFrame': 'baseline, 24 hours post-injection', 'description': 'The Edinburgh Postnatal Depression Scale (EPDS) score ranges from 0 to 30. Higher scores indicate worse outcome, with a score of 10 or greater indicating depression. The value reported is the score at baseline minus the score at 24 hours post-injection.'}, {'measure': 'Change in Anxiety as Indicated by Generalized Anxiety Disorder 7-Item (GAD-7) Scale', 'timeFrame': 'baseline, 24 hours post-injection', 'description': 'The Generalized Anxiety Disorder 7-Item (GAD-7) Scale score ranges from 0 to 21, with higher scores indicating greater anxiety. The value reported is the score at baseline minus the score 24 hours post-injection.'}, {'measure': 'Change in Depression as Indicated by Patient Health Questionnaire (PHQ-9)', 'timeFrame': 'baseline, 24 hours post-injection', 'description': 'The Patient Health Questionnaire (PHQ-9) score ranges from 0 to 27, with greater scores indicating more severe depression.'}, {'measure': 'Change in Behavioral Suicidal Events (Suicidal Ideation), as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)', 'timeFrame': 'baseline, 24 hours post-injection', 'description': 'The C-SSRS is a suicidal ideation and behavior rating scale with yes/no responses. The first part (Items 1-5) rates an individual\'s degree of suicidal ideation on a 0-5 scale, ranging from "wish to be dead" to "active suicidal ideation with specific plan and intent and behaviors". The C-SSRS outcomes are categories and have binary responses (yes/no). Suicidal ideation is considered when the patient responds a "yes" answer at any time during treatment to any one of the five suicidal ideation questions (Categories 1-5) on the C-SSRS. The sum of the 5 intensity item scores create a total score (range 0 to 25) to represent the intensity rating (higher scores indicate more severe suicidal ideation).'}, {'measure': 'Change in Behavioral Suicidal Events (Suicidal Behavior), as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)', 'timeFrame': 'baseline, 24 hours post-injection', 'description': 'The questions 6-10 of the C-SSRS are related to suicidal behavior, and the outcome is a simple yes/no response. Suicidal behavior occurs if the patient answers a "yes" at any time during treatment to any one of the five suicidal behavior questions (Categories 6-10) on the C-SSRS.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Post Partum Depression']}, 'descriptionModule': {'briefSummary': 'Postpartum depression is a non-psychotic major or minor depressive episode that occurs during pregnancy or within 12 months of post-partum period. The nature of symptoms is same as depressive episode characterized by depressed mood, anxiety, sleep difficulties, suicidal thoughts, tiredness and diminished interest in pleasurable activities. Severe maternal depression affects children by increasing the risk of emotional and behavioral and physical health problems and cognitive difficulties. Thus early screening and intervention is critical in reducing the negative impact of PND in the mother and child, family and the community.\n\nThe purpose of this study is to assess the safety, pharmacokinetics and antidepressant efficacy of sub-anesthetic dose of intravenous ketamine in perinatal depression.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female subjects, ages 18-45 years\n* Experienced a major depressive episode in the postpartum period beginning within the first 4 weeks following delivery and with moderate or severe symptoms (\\>12 EPDS or \\>14 HAM-D).\n* No or partial response to adequate doses of SSRI medications to treat PND for longer than 6 weeks.\n* PND patients will be requested to maintain the stable dose of antidepressants while enrolled in the study trial.\n* Patients that can speak and read the English language, are able to understand the study procedures and sign the informed consent\n\nExclusion Criteria:\n\n* No current or past psychosis or severe personality disorder.\n* No current substance abuse or dependence.\n* No serious and imminent suicidal or homicidal risk.\n* No recent or history of major and unstable medical problems that affect brain anatomy, neurochemistry, or function.\n* Not diagnosed with cardiovascular disorders.\n* No increased risk of laryngospasm or active upper respiratory infections.\n* Not diagnosed with an intellectual disability or neurodegenerative diseases.\n* Mothers that are currently breastfeeding.\n* No current pregnancy.'}, 'identificationModule': {'nctId': 'NCT04011592', 'briefTitle': 'Efficacy And Tolerability Of Sub-Anesthetic Ketamine In Postpartum Depression', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center, Houston'}, 'officialTitle': 'Efficacy And Tolerability Of Sub-Anesthetic Ketamine In Postpartum Depression', 'orgStudyIdInfo': {'id': 'HSC-MS-18-0416'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ketamine 0.5 mg/kg, then Ketamine 0.2 mg/kg', 'description': 'single intravenous infusion of Ketamine (0.5 mg/kg), washout period of seven days, and then single intravenous infusion of Ketamine (0.2 mg/kg)', 'interventionNames': ['Drug: Ketamine 0.5 mg/kg', 'Drug: Ketamine 0.2 mg/kg']}, {'type': 'EXPERIMENTAL', 'label': 'Ketamine 0.2 mg/kg, then Ketamine 0.5 mg/kg', 'description': 'single intravenous infusion of Ketamine (0.2 mg/kg), washout period of seven days, and then single intravenous infusion of Ketamine (0.5 mg/kg)', 'interventionNames': ['Drug: Ketamine 0.5 mg/kg', 'Drug: Ketamine 0.2 mg/kg']}], 'interventions': [{'name': 'Ketamine 0.5 mg/kg', 'type': 'DRUG', 'otherNames': ['Ketamine Hydrochloride'], 'description': 'single intravenous infusion of Ketamine (0.5 mg/kg)', 'armGroupLabels': ['Ketamine 0.2 mg/kg, then Ketamine 0.5 mg/kg', 'Ketamine 0.5 mg/kg, then Ketamine 0.2 mg/kg']}, {'name': 'Ketamine 0.2 mg/kg', 'type': 'DRUG', 'description': 'single intravenous infusion of Ketamine (0.2 mg/kg)', 'armGroupLabels': ['Ketamine 0.2 mg/kg, then Ketamine 0.5 mg/kg', 'Ketamine 0.5 mg/kg, then Ketamine 0.2 mg/kg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77054', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'The University of Texas Health Science Center at Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Sudhakar Selvaraj, 713-486-2837', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UTHealth Science Center at Houston'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Health Science Center, Houston', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Sudhakar Selvaraj', 'investigatorAffiliation': 'The University of Texas Health Science Center, Houston'}}}}