Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2025-12-24 @ 4:44 PM
Study NCT ID:
NCT04154150
Status:
TERMINATED
Last Update Posted:
2024-07-22
First Post:
2019-11-04
Is Possible Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Ketamine + Cognitive Training for Suicidality in the Medical Setting: Pilot
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-12-16', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D013406', 'term': 'Suicide, Attempted'}], 'ancestors': [{'id': 'D013405', 'term': 'Suicide'}, {'id': 'D016728', 'term': 'Self-Injurious Behavior'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000091942', 'term': 'Cognitive Training'}], 'ancestors': [{'id': 'D000066530', 'term': 'Neurological Rehabilitation'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'pricerb@upmc.edu', 'phone': '412-383-2150', 'title': 'Dr. Rebecca Price', 'organization': 'University of Pittsburgh'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Pilot study leading to small numbers of patients in each treatment arm. Descriptive statistics are reported without statistical analysis to directly compare groups, given the small number of patients within each group leading to low statistical power.'}}, 'adverseEventsModule': {'timeFrame': '24 hours', 'description': 'Adverse events were collected using the Patient Rated Inventory of Side Effects (PRISE; Rush et al 2004) instrument. Open-ended questions were also used to inquire about any additional adverse events not captured on the PRISE. Adverse events were tallied for all symptoms that were reported as new or worsening from pre-infusion baseline with onset during the infusion and/or within the subsequent 24hr period.', 'eventGroups': [{'id': 'EG000', 'title': 'Ketamine + Cognitive Training', 'description': 'Intravenous ketamine: Single subanesthetic infusion of ketamine (0.5mg/kg)\n\nCognitive training: 8 sessions of computer-based cognitive training', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 7, 'seriousNumAtRisk': 7, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Ketamine + Sham Training', 'description': 'Intravenous ketamine: Single subanesthetic infusion of ketamine (0.5mg/kg)\n\nSham Training: 8 sessions of computer-based sham training', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 9, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'decreased energy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'difficulty sleeping: too little', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'difficulty sleeping: too much', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'emotional indifference', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': "feeling 'high'", 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'increased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'loss of sexual desire', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'restlessness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'sweating', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'tremors', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'trouble achieving orgasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Montgomery Asberg Depression Rating Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ketamine + Cognitive Training', 'description': 'Intravenous ketamine: Single subanesthetic infusion of ketamine (0.5mg/kg)\n\nCognitive training: 8 sessions of computer-based cognitive training'}, {'id': 'OG001', 'title': 'Ketamine + Sham Training', 'description': 'Intravenous ketamine: Single subanesthetic infusion of ketamine (0.5mg/kg)\n\nSham Training: 8 sessions of computer-based sham training'}], 'classes': [{'categories': [{'measurements': [{'value': '18.43', 'spread': '8.5', 'groupId': 'OG000'}, {'value': '15.44', 'spread': '10.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'infusion +24 hours', 'description': 'depression severity; range 0-60; high score=worse outcome', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were assigned to the arm and were willing and able to complete this specific measure.'}, {'type': 'PRIMARY', 'title': 'Montgomery Asberg Depression Rating Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ketamine + Cognitive Training', 'description': 'Intravenous ketamine: Single subanesthetic infusion of ketamine (0.5mg/kg)\n\nCognitive training: 8 sessions of computer-based cognitive training'}, {'id': 'OG001', 'title': 'Ketamine + Sham Training', 'description': 'Intravenous ketamine: Single subanesthetic infusion of ketamine (0.5mg/kg)\n\nSham Training: 8 sessions of computer-based sham training'}], 'classes': [{'categories': [{'measurements': [{'value': '19.14', 'spread': '9.8', 'groupId': 'OG000'}, {'value': '16.13', 'spread': '9.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'infusion +5 days', 'description': 'depression severity; range 0-60; high score=worse outcome', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were assigned to the arm and were willing and able to complete this specific measure.'}, {'type': 'PRIMARY', 'title': 'Montgomery Asberg Depression Rating Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ketamine + Cognitive Training', 'description': 'Intravenous ketamine: Single subanesthetic infusion of ketamine (0.5mg/kg)\n\nCognitive training: 8 sessions of computer-based cognitive training'}, {'id': 'OG001', 'title': 'Ketamine + Sham Training', 'description': 'Intravenous ketamine: Single subanesthetic infusion of ketamine (0.5mg/kg)\n\nSham Training: 8 sessions of computer-based sham training'}], 'classes': [{'categories': [{'measurements': [{'value': '13.67', 'spread': '14.2', 'groupId': 'OG000'}, {'value': '17.29', 'spread': '11.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'infusion +12 days', 'description': 'depression severity; range 0-60; high score=worse outcome', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were assigned to the arm and were willing and able to complete this specific measure.'}, {'type': 'PRIMARY', 'title': 'Montgomery Asberg Depression Rating Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ketamine + Cognitive Training', 'description': 'Intravenous ketamine: Single subanesthetic infusion of ketamine (0.5mg/kg)\n\nCognitive training: 8 sessions of computer-based cognitive training'}, {'id': 'OG001', 'title': 'Ketamine + Sham Training', 'description': 'Intravenous ketamine: Single subanesthetic infusion of ketamine (0.5mg/kg)\n\nSham Training: 8 sessions of computer-based sham training'}], 'classes': [{'categories': [{'measurements': [{'value': '20.67', 'spread': '7.6', 'groupId': 'OG000'}, {'value': '14.00', 'spread': '13.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'infusion +1 month', 'description': 'depression severity; range 0-60; high score=worse outcome', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were assigned to the arm and were willing and able to complete this specific measure.'}, {'type': 'PRIMARY', 'title': 'Montgomery Asberg Depression Rating Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ketamine + Cognitive Training', 'description': 'Intravenous ketamine: Single subanesthetic infusion of ketamine (0.5mg/kg)\n\nCognitive training: 8 sessions of computer-based cognitive training'}, {'id': 'OG001', 'title': 'Ketamine + Sham Training', 'description': 'Intravenous ketamine: Single subanesthetic infusion of ketamine (0.5mg/kg)\n\nSham Training: 8 sessions of computer-based sham training'}], 'classes': [{'categories': [{'measurements': [{'value': '13.00', 'spread': '13.6', 'groupId': 'OG000'}, {'value': '14.71', 'spread': '10.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'infusion +3 months', 'description': 'depression severity; range 0-60; high score=worse outcome', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were assigned to the arm and were willing and able to complete this specific measure.'}, {'type': 'PRIMARY', 'title': 'Montgomery Asberg Depression Rating Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ketamine + Cognitive Training', 'description': 'Intravenous ketamine: Single subanesthetic infusion of ketamine (0.5mg/kg)\n\nCognitive training: 8 sessions of computer-based cognitive training'}, {'id': 'OG001', 'title': 'Ketamine + Sham Training', 'description': 'Intravenous ketamine: Single subanesthetic infusion of ketamine (0.5mg/kg)\n\nSham Training: 8 sessions of computer-based sham training'}], 'classes': [{'categories': [{'measurements': [{'value': '13.20', 'spread': '14.7', 'groupId': 'OG000'}, {'value': '17.43', 'spread': '9.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'infusion +6 months', 'description': 'depression severity; range 0-60; high score=worse outcome', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were assigned to the arm and were willing and able to complete this specific measure.'}, {'type': 'PRIMARY', 'title': 'Adult Suicide Ideation Questionnaire (Past Day Version)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ketamine + Cognitive Training', 'description': 'Intravenous ketamine: Single subanesthetic infusion of ketamine (0.5mg/kg)\n\nCognitive training: 8 sessions of computer-based cognitive training'}, {'id': 'OG001', 'title': 'Ketamine + Sham Training', 'description': 'Intravenous ketamine: Single subanesthetic infusion of ketamine (0.5mg/kg)\n\nSham Training: 8 sessions of computer-based sham training'}], 'classes': [{'categories': [{'measurements': [{'value': '32.67', 'spread': '8.45', 'groupId': 'OG000'}, {'value': '41.89', 'spread': '38.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'infusion +24 hours', 'description': 'suicidal ideation/thoughts; range 0-150; high score=worse outcome', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were assigned to the arm and were willing and able to complete this specific measure.'}, {'type': 'PRIMARY', 'title': 'Adult Suicide Ideation Questionnaire (Past Day Version)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ketamine + Cognitive Training', 'description': 'Intravenous ketamine: Single subanesthetic infusion of ketamine (0.5mg/kg)\n\nCognitive training: 8 sessions of computer-based cognitive training'}, {'id': 'OG001', 'title': 'Ketamine + Sham Training', 'description': 'Intravenous ketamine: Single subanesthetic infusion of ketamine (0.5mg/kg)\n\nSham Training: 8 sessions of computer-based sham training'}], 'classes': [{'categories': [{'measurements': [{'value': '20.00', 'spread': '9.98', 'groupId': 'OG000'}, {'value': '22.88', 'spread': '10.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'infusion +5 days', 'description': 'suicidal ideation/thoughts; range 0-150; high score=worse outcome', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were assigned to the arm and were willing and able to complete this specific measure.'}, {'type': 'PRIMARY', 'title': 'Adult Suicide Ideation Questionnaire (Past Day Version)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ketamine + Cognitive Training', 'description': 'Intravenous ketamine: Single subanesthetic infusion of ketamine (0.5mg/kg)\n\nCognitive training: 8 sessions of computer-based cognitive training'}, {'id': 'OG001', 'title': 'Ketamine + Sham Training', 'description': 'Intravenous ketamine: Single subanesthetic infusion of ketamine (0.5mg/kg)\n\nSham Training: 8 sessions of computer-based sham training'}], 'classes': [{'categories': [{'measurements': [{'value': '17.17', 'spread': '13.4', 'groupId': 'OG000'}, {'value': '31.86', 'spread': '34.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'infusion +12 days', 'description': 'suicidal ideation/thoughts; range 0-150; high score=worse outcome', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were assigned to the arm and were willing and able to complete this specific measure.'}, {'type': 'PRIMARY', 'title': 'Adult Suicide Ideation Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ketamine + Cognitive Training', 'description': 'Intravenous ketamine: Single subanesthetic infusion of ketamine (0.5mg/kg)\n\nCognitive training: 8 sessions of computer-based cognitive training'}, {'id': 'OG001', 'title': 'Ketamine + Sham Training', 'description': 'Intravenous ketamine: Single subanesthetic infusion of ketamine (0.5mg/kg)\n\nSham Training: 8 sessions of computer-based sham training'}], 'classes': [{'categories': [{'measurements': [{'value': '23.60', 'spread': '22.9', 'groupId': 'OG000'}, {'value': '41.83', 'spread': '48.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'infusion +1 month', 'description': 'suicidal ideation/thoughts; range 0-150; high score=worse outcome', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were assigned to the arm and were willing and able to complete this specific measure.'}, {'type': 'PRIMARY', 'title': 'Adult Suicide Ideation Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ketamine + Cognitive Training', 'description': 'Intravenous ketamine: Single subanesthetic infusion of ketamine (0.5mg/kg)\n\nCognitive training: 8 sessions of computer-based cognitive training'}, {'id': 'OG001', 'title': 'Ketamine + Sham Training', 'description': 'Intravenous ketamine: Single subanesthetic infusion of ketamine (0.5mg/kg)\n\nSham Training: 8 sessions of computer-based sham training'}], 'classes': [{'categories': [{'measurements': [{'value': '25.20', 'spread': '26.2', 'groupId': 'OG000'}, {'value': '37.50', 'spread': '46.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'infusion +3 months', 'description': 'suicidal ideation/thoughts; range 0-150; high score=worse outcome', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were assigned to the arm and were willing and able to complete this specific measure.'}, {'type': 'PRIMARY', 'title': 'Adult Suicide Ideation Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ketamine + Cognitive Training', 'description': 'Intravenous ketamine: Single subanesthetic infusion of ketamine (0.5mg/kg)\n\nCognitive training: 8 sessions of computer-based cognitive training'}, {'id': 'OG001', 'title': 'Ketamine + Sham Training', 'description': 'Intravenous ketamine: Single subanesthetic infusion of ketamine (0.5mg/kg)\n\nSham Training: 8 sessions of computer-based sham training'}], 'classes': [{'categories': [{'measurements': [{'value': '29.5', 'spread': '40.3', 'groupId': 'OG000'}, {'value': '45.75', 'spread': '60.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'infusion +6 months', 'description': 'suicidal ideation/thoughts; range 0-150; high score=worse outcome', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were assigned to the arm and were willing and able to complete this specific measure.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Occurrence of Suicidal Behaviors Per Medical Chart Review', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ketamine + Cognitive Training', 'description': 'Intravenous ketamine: Single subanesthetic infusion of ketamine (0.5mg/kg)\n\nCognitive training: 8 sessions of computer-based cognitive training'}, {'id': 'OG001', 'title': 'Ketamine + Sham Training', 'description': 'Intravenous ketamine: Single subanesthetic infusion of ketamine (0.5mg/kg)\n\nSham Training: 8 sessions of computer-based sham training'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'infusion +6 months', 'description': 'Number of participants with occurrence of any suicidal act (derived from medical chart) including: re-attempt, re-hospitalization for suicidality, or completed suicide', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were assigned to the arm.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Reporting Suicidal Behaviors Per the Columbia Suicide Severity Rating Scale (CSSRS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ketamine + Cognitive Training', 'description': 'Intravenous ketamine: Single subanesthetic infusion of ketamine (0.5mg/kg)\n\nCognitive training: 8 sessions of computer-based cognitive training'}, {'id': 'OG001', 'title': 'Ketamine + Sham Training', 'description': 'Intravenous ketamine: Single subanesthetic infusion of ketamine (0.5mg/kg)\n\nSham Training: 8 sessions of computer-based sham training'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'infusion +6 months', 'description': "Number of participants with occurrence of any suicidal act (derived from Columbia Suicide Severity Rating Scale interview; each of the following items was scored yes/no for the period since last assessment: re-attempt, re-hospitalization for suicidality, or completed suicide. Analyzed outcome measure is # of participants with 1 or more 'yes' responses.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were assigned to the arm and were willing and able to complete at least one CSSRS interview at any point during follow-up.'}, {'type': 'SECONDARY', 'title': 'Quick Inventory of Depressive Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ketamine + Cognitive Training', 'description': 'Intravenous ketamine: Single subanesthetic infusion of ketamine (0.5mg/kg)\n\nCognitive training: 8 sessions of computer-based cognitive training'}, {'id': 'OG001', 'title': 'Ketamine + Sham Training', 'description': 'Intravenous ketamine: Single subanesthetic infusion of ketamine (0.5mg/kg)\n\nSham Training: 8 sessions of computer-based sham training'}], 'classes': [{'categories': [{'measurements': [{'value': '12.83', 'spread': '4.1', 'groupId': 'OG000'}, {'value': '11.22', 'spread': '6.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'infusion +24 hours', 'description': 'Self-reported depression (range: 0-27; higher scores = worse outcome)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were assigned to the arm and were willing and able to complete this specific measure.'}, {'type': 'SECONDARY', 'title': 'Quick Inventory of Depressive Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ketamine + Cognitive Training', 'description': 'Intravenous ketamine: Single subanesthetic infusion of ketamine (0.5mg/kg)\n\nCognitive training: 8 sessions of computer-based cognitive training'}, {'id': 'OG001', 'title': 'Ketamine + Sham Training', 'description': 'Intravenous ketamine: Single subanesthetic infusion of ketamine (0.5mg/kg)\n\nSham Training: 8 sessions of computer-based sham training'}], 'classes': [{'categories': [{'measurements': [{'value': '9.86', 'spread': '5.8', 'groupId': 'OG000'}, {'value': '9.50', 'spread': '6.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'infusion +5 days', 'description': 'Self-reported depression (range: 0-27; higher scores = worse outcome)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were assigned to the arm and were willing and able to complete this specific measure.'}, {'type': 'SECONDARY', 'title': 'Quick Inventory of Depressive Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ketamine + Cognitive Training', 'description': 'Intravenous ketamine: Single subanesthetic infusion of ketamine (0.5mg/kg)\n\nCognitive training: 8 sessions of computer-based cognitive training'}, {'id': 'OG001', 'title': 'Ketamine + Sham Training', 'description': 'Intravenous ketamine: Single subanesthetic infusion of ketamine (0.5mg/kg)\n\nSham Training: 8 sessions of computer-based sham training'}], 'classes': [{'categories': [{'measurements': [{'value': '8.33', 'spread': '7.1', 'groupId': 'OG000'}, {'value': '9.86', 'spread': '7.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'infusion +12 days', 'description': 'Self-reported depression (range: 0-27; higher scores = worse outcome)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were assigned to the arm and were willing and able to complete this specific measure.'}, {'type': 'SECONDARY', 'title': 'Quick Inventory of Depressive Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ketamine + Cognitive Training', 'description': 'Intravenous ketamine: Single subanesthetic infusion of ketamine (0.5mg/kg)\n\nCognitive training: 8 sessions of computer-based cognitive training'}, {'id': 'OG001', 'title': 'Ketamine + Sham Training', 'description': 'Intravenous ketamine: Single subanesthetic infusion of ketamine (0.5mg/kg)\n\nSham Training: 8 sessions of computer-based sham training'}], 'classes': [{'categories': [{'measurements': [{'value': '9.60', 'spread': '3.4', 'groupId': 'OG000'}, {'value': '9.33', 'spread': '7.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'infusion +1 month', 'description': 'Self-reported depression (range: 0-27; higher scores = worse outcome)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were assigned to the arm and were willing and able to complete this specific measure.'}, {'type': 'SECONDARY', 'title': 'Quick Inventory of Depressive Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ketamine + Cognitive Training', 'description': 'Intravenous ketamine: Single subanesthetic infusion of ketamine (0.5mg/kg)\n\nCognitive training: 8 sessions of computer-based cognitive training'}, {'id': 'OG001', 'title': 'Ketamine + Sham Training', 'description': 'Intravenous ketamine: Single subanesthetic infusion of ketamine (0.5mg/kg)\n\nSham Training: 8 sessions of computer-based sham training'}], 'classes': [{'categories': [{'measurements': [{'value': '10.60', 'spread': '7.1', 'groupId': 'OG000'}, {'value': '9.17', 'spread': '7.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'infusion +3 months', 'description': 'Self-reported depression (range: 0-27; higher scores = worse outcome)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were assigned to the arm and were willing and able to complete this specific measure.'}, {'type': 'SECONDARY', 'title': 'Quick Inventory of Depressive Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ketamine + Cognitive Training', 'description': 'Intravenous ketamine: Single subanesthetic infusion of ketamine (0.5mg/kg)\n\nCognitive training: 8 sessions of computer-based cognitive training'}, {'id': 'OG001', 'title': 'Ketamine + Sham Training', 'description': 'Intravenous ketamine: Single subanesthetic infusion of ketamine (0.5mg/kg)\n\nSham Training: 8 sessions of computer-based sham training'}], 'classes': [{'categories': [{'measurements': [{'value': '10.00', 'spread': '10.0', 'groupId': 'OG000'}, {'value': '12.25', 'spread': '10.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'infusion +6 months', 'description': 'Self-reported depression (range: 0-27; higher scores = worse outcome)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were assigned to the arm and were willing and able to complete this specific measure.'}, {'type': 'SECONDARY', 'title': 'Scale for Suicide Ideation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ketamine + Cognitive Training', 'description': 'Intravenous ketamine: Single subanesthetic infusion of ketamine (0.5mg/kg)\n\nCognitive training: 8 sessions of computer-based cognitive training'}, {'id': 'OG001', 'title': 'Ketamine + Sham Training', 'description': 'Intravenous ketamine: Single subanesthetic infusion of ketamine (0.5mg/kg)\n\nSham Training: 8 sessions of computer-based sham training'}], 'classes': [{'categories': [{'measurements': [{'value': '8.50', 'spread': '12.0', 'groupId': 'OG000'}, {'value': '0.80', 'spread': '1.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'infusion +24 hours', 'description': 'suicidal ideation/thoughts; range 0-38; high score=worse outcome', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were assigned to the arm and were willing and able to complete this specific measure. Measure added to protocol after first 4 patients.'}, {'type': 'SECONDARY', 'title': 'Scale for Suicide Ideation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ketamine + Cognitive Training', 'description': 'Intravenous ketamine: Single subanesthetic infusion of ketamine (0.5mg/kg)\n\nCognitive training: 8 sessions of computer-based cognitive training'}, {'id': 'OG001', 'title': 'Ketamine + Sham Training', 'description': 'Intravenous ketamine: Single subanesthetic infusion of ketamine (0.5mg/kg)\n\nSham Training: 8 sessions of computer-based sham training'}], 'classes': [{'categories': [{'measurements': [{'value': '0.50', 'spread': '.71', 'groupId': 'OG000'}, {'value': '6.60', 'spread': '9.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'infusion +5 days', 'description': 'suicidal ideation/thoughts; range 0-38; high score=worse outcome', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were assigned to the arm and were willing and able to complete this specific measure. Measure added to protocol after first 4 patients.'}, {'type': 'SECONDARY', 'title': 'Scale for Suicide Ideation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ketamine + Cognitive Training', 'description': 'Intravenous ketamine: Single subanesthetic infusion of ketamine (0.5mg/kg)\n\nCognitive training: 8 sessions of computer-based cognitive training'}, {'id': 'OG001', 'title': 'Ketamine + Sham Training', 'description': 'Intravenous ketamine: Single subanesthetic infusion of ketamine (0.5mg/kg)\n\nSham Training: 8 sessions of computer-based sham training'}], 'classes': [{'categories': [{'measurements': [{'value': '4.50', 'spread': '9.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'infusion +12 days', 'description': 'suicidal ideation/thoughts; range 0-38; high score=worse outcome', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were assigned to the arm and were willing and able to complete this specific measure. Measure added to protocol after first 4 patients.'}, {'type': 'SECONDARY', 'title': 'Scale for Suicide Ideation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ketamine + Cognitive Training', 'description': 'Intravenous ketamine: Single subanesthetic infusion of ketamine (0.5mg/kg)\n\nCognitive training: 8 sessions of computer-based cognitive training'}, {'id': 'OG001', 'title': 'Ketamine + Sham Training', 'description': 'Intravenous ketamine: Single subanesthetic infusion of ketamine (0.5mg/kg)\n\nSham Training: 8 sessions of computer-based sham training'}], 'classes': [{'categories': [{'measurements': [{'value': '13.00', 'groupId': 'OG000'}, {'value': '4.67', 'spread': '7.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'infusion +1 month', 'description': 'suicidal ideation/thoughts; range 0-38; high score=worse outcome', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were assigned to the arm and were willing and able to complete this specific measure. Measure added to protocol after first 4 patients.'}, {'type': 'SECONDARY', 'title': 'Scale for Suicide Ideation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ketamine + Cognitive Training', 'description': 'Intravenous ketamine: Single subanesthetic infusion of ketamine (0.5mg/kg)\n\nCognitive training: 8 sessions of computer-based cognitive training'}, {'id': 'OG001', 'title': 'Ketamine + Sham Training', 'description': 'Intravenous ketamine: Single subanesthetic infusion of ketamine (0.5mg/kg)\n\nSham Training: 8 sessions of computer-based sham training'}], 'classes': [{'categories': [{'measurements': [{'value': '4.00', 'spread': '7.3', 'groupId': 'OG000'}, {'value': '5.83', 'spread': '9.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'infusion +3 months', 'description': 'suicidal ideation/thoughts; range 0-38; high score=worse outcome', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were assigned to the arm and were willing and able to complete this specific measure. Measure added to protocol after first 4 patients.'}, {'type': 'SECONDARY', 'title': 'Scale for Suicide Ideation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ketamine + Cognitive Training', 'description': 'Intravenous ketamine: Single subanesthetic infusion of ketamine (0.5mg/kg)\n\nCognitive training: 8 sessions of computer-based cognitive training'}, {'id': 'OG001', 'title': 'Ketamine + Sham Training', 'description': 'Intravenous ketamine: Single subanesthetic infusion of ketamine (0.5mg/kg)\n\nSham Training: 8 sessions of computer-based sham training'}], 'classes': [{'categories': [{'measurements': [{'value': '5.40', 'spread': '12.1', 'groupId': 'OG000'}, {'value': '6.86', 'spread': '9.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'infusion +6 months', 'description': 'suicidal ideation/thoughts; range 0-38; high score=worse outcome', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were assigned to the arm and were willing and able to complete this specific measure. Measure added to protocol after first 4 patients.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ketamine + Cognitive Training', 'description': 'Intravenous ketamine: Single subanesthetic infusion of ketamine (0.5mg/kg)\n\nCognitive training: 8 sessions of computer-based cognitive training'}, {'id': 'FG001', 'title': 'Ketamine + Sham Training', 'description': 'Intravenous ketamine: Single subanesthetic infusion of ketamine (0.5mg/kg)\n\nSham Training: 8 sessions of computer-based sham training'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Ketamine + Cognitive Training', 'description': 'Intravenous ketamine: Single subanesthetic infusion of ketamine (0.5mg/kg)\n\nCognitive training: 8 sessions of computer-based cognitive training'}, {'id': 'BG001', 'title': 'Ketamine + Sham Training', 'description': 'Intravenous ketamine: Single subanesthetic infusion of ketamine (0.5mg/kg)\n\nSham Training: 8 sessions of computer-based sham training'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '32.29', 'spread': '14.80', 'groupId': 'BG000'}, {'value': '35.44', 'spread': '17.74', 'groupId': 'BG001'}, {'value': '34.06', 'spread': '16.06', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Male', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'Female', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}, {'title': 'Transgender (female-to-male)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}], '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': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '13', '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': 'Montgomery Asberg Depression Rating Scale', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '39', 'spread': '6.4', 'groupId': 'BG000'}, {'value': '36.8', 'spread': '6.3', 'groupId': 'BG001'}, {'value': '37.8', 'spread': '6.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'depression severity; range 0-60; high score=worse outcome', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Adult Suicide Ideation Questionnaire', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '85.0', 'spread': '35.2', 'groupId': 'BG000'}, {'value': '96.6', 'spread': '31.5', 'groupId': 'BG001'}, {'value': '91.9', 'spread': '32.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'suicidal ideation/thoughts; range 0-150; high score=worse outcome', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Measure not acquired at baseline from 1 participant'}, {'title': 'Quick Inventory of Depressive Symptoms', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '17.8', 'spread': '3.1', 'groupId': 'BG000'}, {'value': '14.4', 'spread': '5.95', 'groupId': 'BG001'}, {'value': '15.9', 'spread': '5.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Self-reported depression (range: 0-27; higher scores = worse outcome)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Measure not acquired at baseline from 2 participants'}, {'title': 'Scale for Suicide Ideation', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '30.3', 'spread': '2.2', 'groupId': 'BG000'}, {'value': '29.3', 'spread': '1.7', 'groupId': 'BG001'}, {'value': '29.6', 'spread': '1.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'suicidal ideation/thoughts; range 0-38; high score=worse outcome', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Measure not acquired at baseline from 4 participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-01-03', 'size': 116023, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-11-18T13:59', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'whyStopped': 'Midway through this pilot study, funding was obtained to support a much larger study of the same interventions in this clinical population. Therefore the pilot study was halted so as not to compete with enrollment for the larger study.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-12-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2022-03-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-18', 'studyFirstSubmitDate': '2019-11-04', 'resultsFirstSubmitDate': '2022-11-18', 'studyFirstSubmitQcDate': '2019-11-04', 'lastUpdatePostDateStruct': {'date': '2024-07-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-12-15', 'studyFirstPostDateStruct': {'date': '2019-11-06', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-01-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Montgomery Asberg Depression Rating Scale', 'timeFrame': 'infusion +24 hours', 'description': 'depression severity; range 0-60; high score=worse outcome'}, {'measure': 'Montgomery Asberg Depression Rating Scale', 'timeFrame': 'infusion +5 days', 'description': 'depression severity; range 0-60; high score=worse outcome'}, {'measure': 'Montgomery Asberg Depression Rating Scale', 'timeFrame': 'infusion +12 days', 'description': 'depression severity; range 0-60; high score=worse outcome'}, {'measure': 'Montgomery Asberg Depression Rating Scale', 'timeFrame': 'infusion +1 month', 'description': 'depression severity; range 0-60; high score=worse outcome'}, {'measure': 'Montgomery Asberg Depression Rating Scale', 'timeFrame': 'infusion +3 months', 'description': 'depression severity; range 0-60; high score=worse outcome'}, {'measure': 'Montgomery Asberg Depression Rating Scale', 'timeFrame': 'infusion +6 months', 'description': 'depression severity; range 0-60; high score=worse outcome'}, {'measure': 'Adult Suicide Ideation Questionnaire (Past Day Version)', 'timeFrame': 'infusion +24 hours', 'description': 'suicidal ideation/thoughts; range 0-150; high score=worse outcome'}, {'measure': 'Adult Suicide Ideation Questionnaire (Past Day Version)', 'timeFrame': 'infusion +5 days', 'description': 'suicidal ideation/thoughts; range 0-150; high score=worse outcome'}, {'measure': 'Adult Suicide Ideation Questionnaire (Past Day Version)', 'timeFrame': 'infusion +12 days', 'description': 'suicidal ideation/thoughts; range 0-150; high score=worse outcome'}, {'measure': 'Adult Suicide Ideation Questionnaire', 'timeFrame': 'infusion +1 month', 'description': 'suicidal ideation/thoughts; range 0-150; high score=worse outcome'}, {'measure': 'Adult Suicide Ideation Questionnaire', 'timeFrame': 'infusion +3 months', 'description': 'suicidal ideation/thoughts; range 0-150; high score=worse outcome'}, {'measure': 'Adult Suicide Ideation Questionnaire', 'timeFrame': 'infusion +6 months', 'description': 'suicidal ideation/thoughts; range 0-150; high score=worse outcome'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Occurrence of Suicidal Behaviors Per Medical Chart Review', 'timeFrame': 'infusion +6 months', 'description': 'Number of participants with occurrence of any suicidal act (derived from medical chart) including: re-attempt, re-hospitalization for suicidality, or completed suicide'}, {'measure': 'Number of Participants Reporting Suicidal Behaviors Per the Columbia Suicide Severity Rating Scale (CSSRS)', 'timeFrame': 'infusion +6 months', 'description': "Number of participants with occurrence of any suicidal act (derived from Columbia Suicide Severity Rating Scale interview; each of the following items was scored yes/no for the period since last assessment: re-attempt, re-hospitalization for suicidality, or completed suicide. Analyzed outcome measure is # of participants with 1 or more 'yes' responses."}, {'measure': 'Quick Inventory of Depressive Symptoms', 'timeFrame': 'infusion +24 hours', 'description': 'Self-reported depression (range: 0-27; higher scores = worse outcome)'}, {'measure': 'Quick Inventory of Depressive Symptoms', 'timeFrame': 'infusion +5 days', 'description': 'Self-reported depression (range: 0-27; higher scores = worse outcome)'}, {'measure': 'Quick Inventory of Depressive Symptoms', 'timeFrame': 'infusion +12 days', 'description': 'Self-reported depression (range: 0-27; higher scores = worse outcome)'}, {'measure': 'Quick Inventory of Depressive Symptoms', 'timeFrame': 'infusion +1 month', 'description': 'Self-reported depression (range: 0-27; higher scores = worse outcome)'}, {'measure': 'Quick Inventory of Depressive Symptoms', 'timeFrame': 'infusion +3 months', 'description': 'Self-reported depression (range: 0-27; higher scores = worse outcome)'}, {'measure': 'Quick Inventory of Depressive Symptoms', 'timeFrame': 'infusion +6 months', 'description': 'Self-reported depression (range: 0-27; higher scores = worse outcome)'}, {'measure': 'Scale for Suicide Ideation', 'timeFrame': 'infusion +24 hours', 'description': 'suicidal ideation/thoughts; range 0-38; high score=worse outcome'}, {'measure': 'Scale for Suicide Ideation', 'timeFrame': 'infusion +5 days', 'description': 'suicidal ideation/thoughts; range 0-38; high score=worse outcome'}, {'measure': 'Scale for Suicide Ideation', 'timeFrame': 'infusion +12 days', 'description': 'suicidal ideation/thoughts; range 0-38; high score=worse outcome'}, {'measure': 'Scale for Suicide Ideation', 'timeFrame': 'infusion +1 month', 'description': 'suicidal ideation/thoughts; range 0-38; high score=worse outcome'}, {'measure': 'Scale for Suicide Ideation', 'timeFrame': 'infusion +3 months', 'description': 'suicidal ideation/thoughts; range 0-38; high score=worse outcome'}, {'measure': 'Scale for Suicide Ideation', 'timeFrame': 'infusion +6 months', 'description': 'suicidal ideation/thoughts; range 0-38; high score=worse outcome'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Suicide, Attempted']}, 'descriptionModule': {'briefSummary': "This project seeks to identify the acute and longer-term impact of a single dose of intravenous ketamine among suicidal patients referred for psychiatric consultation/liaison in the medical inpatient setting. The investigators will then test whether ketamine's rapid effects can be extended by introducing helpful information delivered by a computer-based training protocol. This work could ultimately lead to the ability to treat suicidality more efficiently and with broader dissemination by rapidly priming the brain for helpful forms of learning.", 'detailedDescription': 'NOTE: In the course of this pilot study, both the primary and secondary outcome measures were supplemented to provide additional, complementary information on the clinical effects of the study interventions, based on confirmation (through study team experience) of the feasibility of acquiring such additional information in the context of our study population, setting, and design.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nParticipants will:\n\n1. be between the ages of 18 and 65 years\n2. be a medical inpatient referred for psychiatric consultation/liaison due to suicidality\n3. possess a level of judgment and understanding sufficient to agree to all procedures required by the protocol and must sign an informed consent document\n4. be deemed an appropriate and reasonable medical candidate for intravenous ketamine by a physician authorized to prescribe medication to the patient during inpatient hospitalization\n\nExclusion Criteria:\n\n1. Presence of current psychotic or autism spectrum disorder or current delirium\n2. Use of a Monoamine Oxidase Inhibitor (MAOI) within the previous 2 weeks\n3. Current pregnancy or breastfeeding\n4. Reading level \\<5th grade as per WRAT-3 reading subtest\n5. Past intolerance or hypersensitivity to ketamine\n6. Patients taking any of the following medications: St John's Wort, theophylline, tramadol, metrizamide\n7. Patients who have received ECT in the past 6 months prior to intake\n8. Patients at risk for withdrawal related issues (e.g., delirium tremens, severe opiate withdrawal) or who present with substance-induced psychosis\n9. Patients who, based on expressed preference and/or home geographic location, are deemed by the Psychiatric Consultation/Liaison service to be likely to receive inpatient psychiatric hospitalization at an alternate location outside of Western Psychiatric Institute \\& Clinic"}, 'identificationModule': {'nctId': 'NCT04154150', 'briefTitle': 'Ketamine + Cognitive Training for Suicidality in the Medical Setting: Pilot', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'Ketamine + Cognitive Training for Suicidality in the Medical Setting: Pilot', 'orgStudyIdInfo': {'id': 'STUDY19100041 (Part 1)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ketamine + Cognitive Training', 'interventionNames': ['Drug: Intravenous ketamine', 'Behavioral: Cognitive training']}, {'type': 'SHAM_COMPARATOR', 'label': 'Ketamine + Sham Training', 'interventionNames': ['Drug: Intravenous ketamine', 'Behavioral: Sham Training']}], 'interventions': [{'name': 'Intravenous ketamine', 'type': 'DRUG', 'description': 'Single subanesthetic infusion of ketamine (0.5mg/kg)', 'armGroupLabels': ['Ketamine + Cognitive Training', 'Ketamine + Sham Training']}, {'name': 'Cognitive training', 'type': 'BEHAVIORAL', 'description': '8 sessions of computer-based cognitive training', 'armGroupLabels': ['Ketamine + Cognitive Training']}, {'name': 'Sham Training', 'type': 'BEHAVIORAL', 'description': '8 sessions of computer-based sham training', 'armGroupLabels': ['Ketamine + Sham Training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rebecca Price', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Psychiatry and Psychology', 'investigatorFullName': 'Rebecca Price', 'investigatorAffiliation': 'University of Pittsburgh'}}}}