Ignite Creation Date:
2025-12-24 @ 10:08 PM
Ignite Modification Date:
2026-02-22 @ 7:03 AM
Study NCT ID:
NCT05168735
Status:
COMPLETED
Last Update Posted:
2024-08-20
First Post:
2021-12-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Ketamine + Mindfulness for Depression
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-07-31', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D003866', 'term': 'Depressive Disorder'}], 'ancestors': [{'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'pricerb@upmc.edu', 'phone': '412-383-2150', 'title': 'Dr. Rebecca Price', 'organization': 'University of Pittsburgh'}, 'certainAgreement': {'piSponsorEmployee': True}, '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 and the Clinician-Administered Dissociative States Scale (CADSS). 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': 'Intravenous Ketamine + Mindfulness Exercises', 'description': 'Intravenous Ketamine: Single infusion of intravenous racemic ketamine (0.5mg/kg over 40min)\n\nBrief Mindfulness Exercises: 30min guided training in mindfulness meditation immediately prior to infusion', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 22, 'seriousNumAtRisk': 22, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Intravenous Ketamine + Academic Exercises', 'description': 'Intravenous Ketamine: Single infusion of intravenous racemic ketamine (0.5mg/kg over 40min)\n\nAcademic Exercises: 30min of mental math and other academic cognitive puzzles completed silently/mentally', 'otherNumAtRisk': 21, 'deathsNumAtRisk': 21, 'otherNumAffected': 21, 'seriousNumAtRisk': 21, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'decreased energy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'difficulty sleeping: too little', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'difficulty sleeping: too much', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'dissociative symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 21}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 14}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'elevated blood pressure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'emotional indifference', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'increased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'increased weight', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'loss of sexual desire', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'restlessness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'sweating', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'tremors', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'trouble achieving orgasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 21, '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': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intravenous Ketamine + Mindfulness Exercises', 'description': 'Intravenous Ketamine: Single infusion of intravenous racemic ketamine (0.5mg/kg over 40min)\n\nBrief Mindfulness Exercises: 30min guided training in mindfulness meditation immediately prior to infusion'}, {'id': 'OG001', 'title': 'Intravenous Ketamine + Academic Exercises', 'description': 'Intravenous Ketamine: Single infusion of intravenous racemic ketamine (0.5mg/kg over 40min)\n\nAcademic Exercises: 30min of mental math and other academic cognitive puzzles completed silently/mentally'}], 'classes': [{'categories': [{'measurements': [{'value': '12.50', 'spread': '7.94', 'groupId': 'OG000'}, {'value': '13.30', 'spread': '8.90', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24hrs post-intervention', 'description': 'Clinician-rated depression (range: 0-60; 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': 'PRIMARY', 'title': 'Montgomery-Asberg Depression Rating Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intravenous Ketamine + Mindfulness Exercises', 'description': 'Intravenous Ketamine: Single infusion of intravenous racemic ketamine (0.5mg/kg over 40min)\n\nBrief Mindfulness Exercises: 30min guided training in mindfulness meditation immediately prior to infusion'}, {'id': 'OG001', 'title': 'Intravenous Ketamine + Academic Exercises', 'description': 'Intravenous Ketamine: Single infusion of intravenous racemic ketamine (0.5mg/kg over 40min)\n\nAcademic Exercises: 30min of mental math and other academic cognitive puzzles completed silently/mentally'}], 'classes': [{'categories': [{'measurements': [{'value': '15.81', 'spread': '7.84', 'groupId': 'OG000'}, {'value': '14.30', 'spread': '10.69', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '5 days post-intervention', 'description': 'Clinician-rated depression (range: 0-60; 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': 'PRIMARY', 'title': 'Montgomery-Asberg Depression Rating Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intravenous Ketamine + Mindfulness Exercises', 'description': 'Intravenous Ketamine: Single infusion of intravenous racemic ketamine (0.5mg/kg over 40min)\n\nBrief Mindfulness Exercises: 30min guided training in mindfulness meditation immediately prior to infusion'}, {'id': 'OG001', 'title': 'Intravenous Ketamine + Academic Exercises', 'description': 'Intravenous Ketamine: Single infusion of intravenous racemic ketamine (0.5mg/kg over 40min)\n\nAcademic Exercises: 30min of mental math and other academic cognitive puzzles completed silently/mentally'}], 'classes': [{'categories': [{'measurements': [{'value': '15.43', 'spread': '8.42', 'groupId': 'OG000'}, {'value': '17.21', 'spread': '11.74', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 days post-intervention', 'description': 'Clinician-rated depression (range: 0-60; 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': 'PRIMARY', 'title': 'Montgomery-Asberg Depression Rating Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intravenous Ketamine + Mindfulness Exercises', 'description': 'Intravenous Ketamine: Single infusion of intravenous racemic ketamine (0.5mg/kg over 40min)\n\nBrief Mindfulness Exercises: 30min guided training in mindfulness meditation immediately prior to infusion'}, {'id': 'OG001', 'title': 'Intravenous Ketamine + Academic Exercises', 'description': 'Intravenous Ketamine: Single infusion of intravenous racemic ketamine (0.5mg/kg over 40min)\n\nAcademic Exercises: 30min of mental math and other academic cognitive puzzles completed silently/mentally'}], 'classes': [{'categories': [{'measurements': [{'value': '18.90', 'spread': '11.71', 'groupId': 'OG000'}, {'value': '17.10', 'spread': '11.39', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '21 days post-intervention', 'description': 'Clinician-rated depression (range: 0-60; 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': 'PRIMARY', 'title': 'Montgomery-Asberg Depression Rating Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intravenous Ketamine + Mindfulness Exercises', 'description': 'Intravenous Ketamine: Single infusion of intravenous racemic ketamine (0.5mg/kg over 40min)\n\nBrief Mindfulness Exercises: 30min guided training in mindfulness meditation immediately prior to infusion'}, {'id': 'OG001', 'title': 'Intravenous Ketamine + Academic Exercises', 'description': 'Intravenous Ketamine: Single infusion of intravenous racemic ketamine (0.5mg/kg over 40min)\n\nAcademic Exercises: 30min of mental math and other academic cognitive puzzles completed silently/mentally'}], 'classes': [{'categories': [{'measurements': [{'value': '18.55', 'spread': '12.02', 'groupId': 'OG000'}, {'value': '20.05', 'spread': '11.64', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 days post-intervention', 'description': 'Clinician-rated depression (range: 0-60; 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': 'PRIMARY', 'title': 'State Mindfulness Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intravenous Ketamine + Mindfulness Exercises', 'description': 'Intravenous Ketamine: Single infusion of intravenous racemic ketamine (0.5mg/kg over 40min)\n\nBrief Mindfulness Exercises: 30min guided training in mindfulness meditation immediately prior to infusion'}, {'id': 'OG001', 'title': 'Intravenous Ketamine + Academic Exercises', 'description': 'Intravenous Ketamine: Single infusion of intravenous racemic ketamine (0.5mg/kg over 40min)\n\nAcademic Exercises: 30min of mental math and other academic cognitive puzzles completed silently/mentally'}], 'classes': [{'categories': [{'measurements': [{'value': '77.68', 'spread': '13.74', 'groupId': 'OG000'}, {'value': '83.33', 'spread': '15.27', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '80min post-infusion', 'description': 'Self-reported mindfulness (range 21-105; higher scores = more mindfulness)', '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': 'Modified Hamilton Depression Rating Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intravenous Ketamine + Mindfulness Exercises', 'description': 'Intravenous Ketamine: Single infusion of intravenous racemic ketamine (0.5mg/kg over 40min)\n\nBrief Mindfulness Exercises: 30min guided training in mindfulness meditation immediately prior to infusion'}, {'id': 'OG001', 'title': 'Intravenous Ketamine + Academic Exercises', 'description': 'Intravenous Ketamine: Single infusion of intravenous racemic ketamine (0.5mg/kg over 40min)\n\nAcademic Exercises: 30min of mental math and other academic cognitive puzzles completed silently/mentally'}], 'classes': [{'categories': [{'measurements': [{'value': '10.00', 'spread': '5.17', 'groupId': 'OG000'}, {'value': '9.55', 'spread': '5.50', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24hrs post-intervention', 'description': 'Clinician-rated depression (range: 0-52; 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': 'Modified Hamilton Depression Rating Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intravenous Ketamine + Mindfulness Exercises', 'description': 'Intravenous Ketamine: Single infusion of intravenous racemic ketamine (0.5mg/kg over 40min)\n\nBrief Mindfulness Exercises: 30min guided training in mindfulness meditation immediately prior to infusion'}, {'id': 'OG001', 'title': 'Intravenous Ketamine + Academic Exercises', 'description': 'Intravenous Ketamine: Single infusion of intravenous racemic ketamine (0.5mg/kg over 40min)\n\nAcademic Exercises: 30min of mental math and other academic cognitive puzzles completed silently/mentally'}], 'classes': [{'categories': [{'measurements': [{'value': '10.95', 'spread': '5.13', 'groupId': 'OG000'}, {'value': '10.15', 'spread': '6.60', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '5 days post-intervention', 'description': 'Clinician-rated depression (range: 0-52; 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': 'Modified Hamilton Depression Rating Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intravenous Ketamine + Mindfulness Exercises', 'description': 'Intravenous Ketamine: Single infusion of intravenous racemic ketamine (0.5mg/kg over 40min)\n\nBrief Mindfulness Exercises: 30min guided training in mindfulness meditation immediately prior to infusion'}, {'id': 'OG001', 'title': 'Intravenous Ketamine + Academic Exercises', 'description': 'Intravenous Ketamine: Single infusion of intravenous racemic ketamine (0.5mg/kg over 40min)\n\nAcademic Exercises: 30min of mental math and other academic cognitive puzzles completed silently/mentally'}], 'classes': [{'categories': [{'measurements': [{'value': '10.67', 'spread': '6.30', 'groupId': 'OG000'}, {'value': '11.11', 'spread': '6.32', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 days post-intervention', 'description': 'Clinician-rated depression (range: 0-52; 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': 'Modified Hamilton Depression Rating Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intravenous Ketamine + Mindfulness Exercises', 'description': 'Intravenous Ketamine: Single infusion of intravenous racemic ketamine (0.5mg/kg over 40min)\n\nBrief Mindfulness Exercises: 30min guided training in mindfulness meditation immediately prior to infusion'}, {'id': 'OG001', 'title': 'Intravenous Ketamine + Academic Exercises', 'description': 'Intravenous Ketamine: Single infusion of intravenous racemic ketamine (0.5mg/kg over 40min)\n\nAcademic Exercises: 30min of mental math and other academic cognitive puzzles completed silently/mentally'}], 'classes': [{'categories': [{'measurements': [{'value': '12.05', 'spread': '7.09', 'groupId': 'OG000'}, {'value': '11.30', 'spread': '6.67', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '21 days post-intervention', 'description': 'Clinician-rated depression (range: 0-52; 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': 'Modified Hamilton Depression Rating Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intravenous Ketamine + Mindfulness Exercises', 'description': 'Intravenous Ketamine: Single infusion of intravenous racemic ketamine (0.5mg/kg over 40min)\n\nBrief Mindfulness Exercises: 30min guided training in mindfulness meditation immediately prior to infusion'}, {'id': 'OG001', 'title': 'Intravenous Ketamine + Academic Exercises', 'description': 'Intravenous Ketamine: Single infusion of intravenous racemic ketamine (0.5mg/kg over 40min)\n\nAcademic Exercises: 30min of mental math and other academic cognitive puzzles completed silently/mentally'}], 'classes': [{'categories': [{'measurements': [{'value': '12.69', 'spread': '7.42', 'groupId': 'OG000'}, {'value': '12.45', 'spread': '6.90', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 days post-intervention', 'description': 'Clinician-rated depression (range: 0-52; 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': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intravenous Ketamine + Mindfulness Exercises', 'description': 'Intravenous Ketamine: Single infusion of intravenous racemic ketamine (0.5mg/kg over 40min)\n\nBrief Mindfulness Exercises: 30min guided training in mindfulness meditation immediately prior to infusion'}, {'id': 'OG001', 'title': 'Intravenous Ketamine + Academic Exercises', 'description': 'Intravenous Ketamine: Single infusion of intravenous racemic ketamine (0.5mg/kg over 40min)\n\nAcademic Exercises: 30min of mental math and other academic cognitive puzzles completed silently/mentally'}], 'classes': [{'categories': [{'measurements': [{'value': '6.55', 'spread': '5.08', 'groupId': 'OG000'}, {'value': '6.90', 'spread': '5.10', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24hrs post-intervention', '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': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intravenous Ketamine + Mindfulness Exercises', 'description': 'Intravenous Ketamine: Single infusion of intravenous racemic ketamine (0.5mg/kg over 40min)\n\nBrief Mindfulness Exercises: 30min guided training in mindfulness meditation immediately prior to infusion'}, {'id': 'OG001', 'title': 'Intravenous Ketamine + Academic Exercises', 'description': 'Intravenous Ketamine: Single infusion of intravenous racemic ketamine (0.5mg/kg over 40min)\n\nAcademic Exercises: 30min of mental math and other academic cognitive puzzles completed silently/mentally'}], 'classes': [{'categories': [{'measurements': [{'value': '8.05', 'spread': '4.31', 'groupId': 'OG000'}, {'value': '9.90', 'spread': '7.58', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '5 days post-intervention', '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': '20', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intravenous Ketamine + Mindfulness Exercises', 'description': 'Intravenous Ketamine: Single infusion of 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'resultsFirstPostDateStruct': {'date': '2024-08-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Sustained Attention Response Task (SART) Omission Errors', 'timeFrame': 'infusion +24 hours (1 day)', 'description': 'performance-based measure of mindful attention'}, {'measure': 'Sustained Attention Response Task (SART) Self-reported Task Focus', 'timeFrame': 'infusion +24 hours (1 day)', 'description': 'self-report rating of being on-task (range: 1-7; higher score=more on-task)'}, {'measure': 'Awe Experience Scale', 'timeFrame': 'infusion +80min', 'description': 'self-report measure of awe-inspiring experiences (range: 30-210; higher score=greater awe)'}, {'measure': 'Dual Probe Video Task', 'timeFrame': 'infusion +24 hours (1 day)', 'description': 'attentional bias (proportion score) towards sad film clips (range: 0-1.0; higher score=greater attention bias towards sad films)'}, {'measure': 'Pain Rating Via Quantitative Sensory Testing', 'timeFrame': '1-hour post-infusion', 'description': 'Pain rating obtained from Quantitative Sensory Testing by mechanical temporal summation (range: 0-10; higher score=more pain)'}, {'measure': 'PROMIS Pain Intensity Score', 'timeFrame': '1-hour post-infusion', 'description': 'PROMIS Pain Intensity Short Form scale T-score (range=0-100; higher score=worse pain)'}, {'measure': 'PROMIS Pain Interference Score', 'timeFrame': '1-hour post-infusion', 'description': 'PROMIS Pain Interference Short Form scale T-score (range=0-100; higher score=worse pain)'}], 'primaryOutcomes': [{'measure': 'Montgomery-Asberg Depression Rating Scale', 'timeFrame': '24hrs post-intervention', 'description': 'Clinician-rated depression (range: 0-60; higher scores = worse outcome)'}, {'measure': 'Montgomery-Asberg Depression Rating Scale', 'timeFrame': '5 days post-intervention', 'description': 'Clinician-rated depression (range: 0-60; higher scores = worse outcome)'}, {'measure': 'Montgomery-Asberg Depression Rating Scale', 'timeFrame': '12 days post-intervention', 'description': 'Clinician-rated depression (range: 0-60; higher scores = worse outcome)'}, {'measure': 'Montgomery-Asberg Depression Rating Scale', 'timeFrame': '21 days post-intervention', 'description': 'Clinician-rated depression (range: 0-60; higher scores = worse outcome)'}, {'measure': 'Montgomery-Asberg Depression Rating Scale', 'timeFrame': '30 days post-intervention', 'description': 'Clinician-rated depression (range: 0-60; higher scores = worse outcome)'}, {'measure': 'State Mindfulness Scale', 'timeFrame': '80min post-infusion', 'description': 'Self-reported mindfulness (range 21-105; higher scores = more mindfulness)'}], 'secondaryOutcomes': [{'measure': 'Modified Hamilton Depression Rating Scale', 'timeFrame': '24hrs post-intervention', 'description': 'Clinician-rated depression (range: 0-52; higher scores = worse outcome)'}, {'measure': 'Modified Hamilton Depression Rating Scale', 'timeFrame': '5 days post-intervention', 'description': 'Clinician-rated depression (range: 0-52; higher scores = worse outcome)'}, {'measure': 'Modified Hamilton Depression Rating Scale', 'timeFrame': '12 days post-intervention', 'description': 'Clinician-rated depression (range: 0-52; higher scores = worse outcome)'}, {'measure': 'Modified Hamilton Depression Rating Scale', 'timeFrame': '21 days post-intervention', 'description': 'Clinician-rated depression (range: 0-52; higher scores = worse outcome)'}, {'measure': 'Modified Hamilton Depression Rating Scale', 'timeFrame': '30 days post-intervention', 'description': 'Clinician-rated depression (range: 0-52; higher scores = worse outcome)'}, {'measure': 'Quick Inventory of Depressive Symptoms', 'timeFrame': '24hrs post-intervention', 'description': 'Self-reported depression (range: 0-27; higher scores = worse outcome)'}, {'measure': 'Quick Inventory of Depressive Symptoms', 'timeFrame': '5 days post-intervention', 'description': 'Self-reported depression (range: 0-27; higher scores = worse outcome)'}, {'measure': 'Quick Inventory of Depressive Symptoms', 'timeFrame': '12 days post-intervention', 'description': 'Self-reported depression (range: 0-27; higher scores = worse outcome)'}, {'measure': 'Quick Inventory of Depressive Symptoms', 'timeFrame': '21 days post-intervention', 'description': 'Self-reported depression (range: 0-27; higher scores = worse outcome)'}, {'measure': 'Quick Inventory of Depressive Symptoms', 'timeFrame': '30 days post-intervention', 'description': 'Self-reported depression (range: 0-27; higher scores = worse outcome)'}, {'measure': 'Hood Mysticism Scale', 'timeFrame': '40 minutes post-intervention', 'description': 'clinician-administered to assess mystical experiences (range: -64 to +64; higher scores = greater mystical experience)'}, {'measure': 'Mindful Attention Awareness Scale', 'timeFrame': '24hrs post-intervention', 'description': 'self-reported trait mindfulness (range: 1-6; higher scores=greater mindfulness)'}, {'measure': 'Mindful Attention Awareness Scale', 'timeFrame': '5 days post-intervention', 'description': 'self-reported trait mindfulness (range: 1-6; higher scores=greater mindfulness)'}, {'measure': 'Mindful Attention Awareness Scale', 'timeFrame': '12 days post-intervention', 'description': 'self-reported trait mindfulness (range: 1-6; higher scores=greater mindfulness)'}, {'measure': 'Mindful Attention Awareness Scale', 'timeFrame': '21 days post-intervention', 'description': 'self-reported trait mindfulness (range: 1-6; higher scores=greater mindfulness)'}, {'measure': 'Mindful Attention Awareness Scale', 'timeFrame': '30 days post-intervention', 'description': 'self-reported trait mindfulness (range: 1-6; higher scores=greater mindfulness)'}, {'measure': 'Daily Spiritual Experience Scale', 'timeFrame': '5 days post-intervention', 'description': 'self-reported spiritual experiences (range: 1-6; higher scores=greater spiritual experience)'}, {'measure': 'Daily Spiritual Experience Scale', 'timeFrame': '12 days post-intervention', 'description': 'self-reported spiritual experiences (range: 1-6; higher scores=greater spiritual experience)'}, {'measure': 'Daily Spiritual Experience Scale', 'timeFrame': '21 days post-intervention', 'description': 'self-reported spiritual experiences (range: 1-6; higher scores=greater spiritual experience)'}, {'measure': 'Daily Spiritual Experience Scale', 'timeFrame': '30 days post-intervention', 'description': 'self-reported spiritual experiences (range: 1-6; higher scores=greater spiritual experience)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Depression, Unipolar']}, 'referencesModule': {'references': [{'pmid': '40964432', 'type': 'DERIVED', 'citation': 'Kheirkhah M, McDonald N, Aepfelbacher J, Rengasamy ML, Shivanekar S, Spotts C, Cooper I, Baumeister A, Bell E, Do-Nguyen K, Woody ML, Hossein S, Henter ID, Nugent AC, Hejazi NS, Jamalabadi H, Yavi M, Walter M, Zarate CA Jr, Price RB. Mindfulness, music, visual occlusion in ketamine therapy for depression: do they change outcomes? A qualitative and quantitative analysis of a randomized controlled trial. Front Psychiatry. 2025 Sep 2;16:1642025. doi: 10.3389/fpsyt.2025.1642025. eCollection 2025.'}]}, 'descriptionModule': {'briefSummary': 'In this project, the investigators will administer a single infusion of IV ketamine to depressed patients and randomize the patients to receive either a) usual/typical infusion conditions or b) mindfulness training and exercises in conjunction with the infusion. Investigators will test whether the conjunction of ketamine + mindfulness enhances the reductions in depression following a single ketamine infusion.', 'detailedDescription': "NOTE: The study's target sample size was revised after beginning the study, based on a revised available budget."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAll participants will:\n\n1. be between the ages of 18 and 65 years,\n2. score ≥ 14 on the Hamilton Depression Rating Scale (modified Ham-D)\n3. possess a level of understanding sufficient to agree to all tests and examinations required by the protocol and must sign an informed consent document\n\nExclusion Criteria:\n\nAll participants:\n\n1. Presence of lifetime bipolar, psychotic, or autism spectrum; current problematic substance use (e.g., ongoing moderate-to-severe substance use disorder);\n2. Acute suicidality or other psychiatric crises requiring treatment escalation. We will use the Columbia Suicide Severity Rating Scale (CSSRS) as both an initial exclusion criteria (CSSRS "Baseline/Screening" Version for past 1month period) and as grounds for rescue/removal (CSSRS "Since Last Visit" form). The CSSRS will be administered using a paper form by an experienced and thoroughly trained clinical assessor on the study team. Subjects with CSSRS suicide ideation scores scored "yes" on items 4 (active suicidal ideation with some intent to act) and/or 5 (active suicidal ideation with specific plan and intent) will be excluded from the study, and if enrolled, will be exited from the study and referred immediately to the nearest emergency mental health facility for additional thorough assessment and appropriate treatment referral.\n3. Changes made to treatment regimen within 4 weeks of baseline assessment.\n4. Reading level \\<6th grade as per patient self-report.\n5. Patients who have received ECT in the past 2 months prior to Screening.\n6. Current pregnancy or breastfeeding\n7. Patients must be reasonable medical candidates for ketamine infusion, as determined by a physician co-investigator. Serious, unstable medical illnesses including respiratory \\[obstructive sleep apnea, or history of difficulty with airway management during previous anesthetics\\], cardiovascular \\[including ischemic heart disease and uncontrolled hypertension\\], and neurologic \\[including history of severe head injury\\] will be exclusions.\n8. Clinically significant abnormal findings of laboratory parameters \\[including urine toxicology screen for unreported drugs of abuse\\], vitals, or ECG.\n9. Uncontrolled or poorly controlled hypertension, as determined by a physician co-investigator\'s review of vitals collected during screening and any other relevant medical history/records.\n10. Patients with one or more seizures without a clear and resolved etiology.\n11. Patients starting hormonal treatment (e.g., estrogen) in the 3 months prior to Screening.\n12. Past intolerance or hypersensitivity to ketamine.\n13. Patients taking medications with known activity at the NMDA or AMPA glutamate receptor \\[riluzole, amantadine, memantine, topiramate, dextromethorphan, D-cycloserine\\], or the mu-opioid receptor \\[opiate medications--morphine, oxycodone, heroin, fentanyl)\\]. However, lamotrigine will not be a study exclusion given that it has been shown not to impact ketamine\'s safety profile or its antidepressant efficacy.\n14. Patients taking any of the following medications: St John\'s Wort, theophylline, tramadol, metrizamide.\n15. Patients who report meditating with mindfulness techniques \\>1 hour weekly (on average) for the past 6 months or longer.'}, 'identificationModule': {'nctId': 'NCT05168735', 'briefTitle': 'Ketamine + Mindfulness for Depression', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'Ketamine + Mindfulness for Depression', 'orgStudyIdInfo': {'id': 'STUDY21110040'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intravenous Ketamine + Mindfulness Exercises', 'interventionNames': ['Drug: Intravenous Ketamine', 'Behavioral: Brief Mindfulness Exercises']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Intravenous Ketamine + Academic Exercises', 'interventionNames': ['Drug: Intravenous Ketamine', 'Behavioral: Academic Exercises']}], 'interventions': [{'name': 'Intravenous Ketamine', 'type': 'DRUG', 'description': 'Single infusion of intravenous racemic ketamine (0.5mg/kg over 40min)', 'armGroupLabels': ['Intravenous Ketamine + Academic Exercises', 'Intravenous Ketamine + Mindfulness Exercises']}, {'name': 'Brief Mindfulness Exercises', 'type': 'BEHAVIORAL', 'description': '30min guided training in mindfulness meditation immediately prior to infusion', 'armGroupLabels': ['Intravenous Ketamine + Mindfulness Exercises']}, {'name': 'Academic Exercises', 'type': 'BEHAVIORAL', 'description': '30min of mental math and other academic cognitive puzzles completed silently/mentally', 'armGroupLabels': ['Intravenous Ketamine + Academic Exercises']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Western Psychiatric Institute and Clinic', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'overallOfficials': [{'name': 'Rebecca Price, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pittsburgh'}]}, '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'}}}}