Ignite Creation Date:
2025-12-24 @ 3:35 PM
Ignite Modification Date:
2026-02-26 @ 3:15 AM
Study NCT ID:
NCT02655692
Status:
COMPLETED
Last Update Posted:
2022-06-02
First Post:
2016-01-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
CAP-Ketamine for Antidepressant Resistant PTSD
Sponsor:
Organization:
Raw JSON
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{'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'john.krystal@yale.edu', 'phone': '203.785.6396', 'title': 'John Krystal', 'organization': 'Yale University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'The study duration was 5 years; time Veterans participated was ~2 months total.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Saline dose\n\nPlacebo: This is a saline placebo/non-active solution.', 'otherNumAtRisk': 55, 'deathsNumAtRisk': 55, 'otherNumAffected': 25, 'seriousNumAtRisk': 55, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Low Dose Ketamine', 'description': 'Low Dose Ketamine (.20 mg/kg)\n\nKetamine: FDA approved anesthetic medication with rapid acting antidepressant effects.', 'otherNumAtRisk': 55, 'deathsNumAtRisk': 55, 'otherNumAffected': 42, 'seriousNumAtRisk': 55, 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A total symptom severity score (range 0-80) with higher scores indicating greater severity for PTSD'}, {'measure': 'The PTSD Checklist (PCL)', 'timeFrame': 'Follow-up 6 - Day 49', 'description': 'The PTSD Checklist (PCL) is a brief measure of the symptoms of Posttraumatic Stress Disorder (PTSD) to measure change in PTSD symptoms. The PCL-5 is a 20-item self-report measure, a total symptom severity score (range - 0-80) is obtained by summing the scores for each of the 20 items. (5-point Likert (0 = "Not at all" to 4 = "Extremely"). A total symptom severity score (range 0-80) with higher scores indicating greater severity for PTSD'}, {'measure': 'The PTSD Checklist (PCL)', 'timeFrame': 'Follow-up 7 - Day 56', 'description': 'The PTSD Checklist (PCL) is a brief measure of the symptoms of Posttraumatic Stress Disorder (PTSD) to measure change in PTSD symptoms. The PCL-5 is a 20-item self-report measure, a total symptom severity score (range - 0-80) is obtained by summing the scores for each of the 20 items. (5-point Likert (0 = "Not at all" to 4 = "Extremely"). A total symptom severity score (range 0-80) with higher scores indicating greater severity for PTSD'}], 'secondaryOutcomes': [{'measure': 'Montgomery-Asberg Depression Rating Scale (MADRS)', 'timeFrame': 'Session 1 - Day 0', 'description': 'Montgomery-Asberg Depression Rating Scale (MADRS) is a clinician rated ten-item diagnostic questionnaire to measure the severity of depression. The overall score ranges from 0 to 60 (0 to 6 - normal/symptom absent; 7 to 19 mild depression; 20 to 34 - moderate depression; \\>34 - severe depression)'}, {'measure': 'Montgomery-Asberg Depression Rating Scale (MADRS)', 'timeFrame': 'Session 2 - Day 1', 'description': 'Montgomery-Asberg Depression Rating Scale (MADRS) is a clinician rated ten-item diagnostic questionnaire to measure the severity of depression. The overall score ranges from 0 to 60 (0 to 6 - normal/symptom absent; 7 to 19 mild depression; 20 to 34 - moderate depression; \\>34 - severe depression)'}, {'measure': 'Montgomery-Asberg Depression Rating Scale (MADRS)', 'timeFrame': 'Session 3 - Day 3', 'description': 'Montgomery-Asberg Depression Rating Scale (MADRS) is a clinician rated ten-item diagnostic questionnaire to measure the severity of depression. The overall score ranges from 0 to 60 (0 to 6 - normal/symptom absent; 7 to 19 mild depression; 20 to 34 - moderate depression; \\>34 - severe depression)'}, {'measure': 'Montgomery-Asberg Depression Rating Scale (MADRS)', 'timeFrame': 'Session 4 - Day 7', 'description': 'Montgomery-Asberg Depression Rating Scale (MADRS) is a clinician rated ten-item diagnostic questionnaire to measure the severity of depression. The overall score ranges from 0 to 60 (0 to 6 - normal/symptom absent; 7 to 19 mild depression; 20 to 34 - moderate depression; \\>34 - severe depression)'}, {'measure': 'Montgomery-Asberg Depression Rating Scale (MADRS)', 'timeFrame': 'Session 5 - Day 10', 'description': 'Montgomery-Asberg Depression Rating Scale (MADRS) is a clinician rated ten-item diagnostic questionnaire to measure the severity of depression. The overall score ranges from 0 to 60 (0 to 6 - normal/symptom absent; 7 to 19 mild depression; 20 to 34 - moderate depression; \\>34 - severe depression)'}, {'measure': 'Montgomery-Asberg Depression Rating Scale (MADRS)', 'timeFrame': 'Session 6 - Day 14', 'description': 'Montgomery-Asberg Depression Rating Scale (MADRS) is a clinician rated ten-item diagnostic questionnaire to measure the severity of depression. The overall score ranges from 0 to 60 (0 to 6 - normal/symptom absent; 7 to 19 mild depression; 20 to 34 - moderate depression; \\>34 - severe depression)'}, {'measure': 'Montgomery-Asberg Depression Rating Scale (MADRS)', 'timeFrame': 'Session 7 - Day 17', 'description': 'Montgomery-Asberg Depression Rating Scale (MADRS) is a clinician rated ten-item diagnostic questionnaire to measure the severity of depression. The overall score ranges from 0 to 60 (0 to 6 - normal/symptom absent; 7 to 19 mild depression; 20 to 34 - moderate depression; \\>34 - severe depression)'}, {'measure': 'Montgomery-Asberg Depression Rating Scale (MADRS)', 'timeFrame': 'Session 8 - Day 21', 'description': 'Montgomery-Asberg Depression Rating Scale (MADRS) is a clinician rated ten-item diagnostic questionnaire to measure the severity of depression. The overall score ranges from 0 to 60 (0 to 6 - normal/symptom absent; 7 to 19 mild depression; 20 to 34 - moderate depression; \\>34 - severe depression)'}, {'measure': 'Montgomery-Asberg Depression Rating Scale (MADRS)', 'timeFrame': 'Session 9 - Day 24', 'description': 'Montgomery-Asberg Depression Rating Scale (MADRS) is a clinician rated ten-item diagnostic questionnaire to measure the severity of depression. The overall score ranges from 0 to 60 (0 to 6 - normal/symptom absent; 7 to 19 mild depression; 20 to 34 - moderate depression; \\>34 - severe depression)'}, {'measure': 'Montgomery-Asberg Depression Rating Scale (MADRS)', 'timeFrame': 'Follow-up 1 - Day 25', 'description': 'Montgomery-Asberg Depression Rating Scale (MADRS) is a clinician rated ten-item diagnostic questionnaire to measure the severity of depression. The overall score ranges from 0 to 60 (0 to 6 - normal/symptom absent; 7 to 19 mild depression; 20 to 34 - moderate depression; \\>34 - severe depression)'}, {'measure': 'Montgomery-Asberg Depression Rating Scale (MADRS)', 'timeFrame': 'Follow-up 2 - Day 28', 'description': 'Montgomery-Asberg Depression Rating Scale (MADRS) is a clinician rated ten-item diagnostic questionnaire to measure the severity of depression. The overall score ranges from 0 to 60 (0 to 6 - normal/symptom absent; 7 to 19 mild depression; 20 to 34 - moderate depression; \\>34 - severe depression)'}, {'measure': 'Montgomery-Asberg Depression Rating Scale (MADRS)', 'timeFrame': 'Follow-up 3 - Day 29', 'description': 'Montgomery-Asberg Depression Rating Scale (MADRS) is a clinician rated ten-item diagnostic questionnaire to measure the severity of depression. The overall score ranges from 0 to 60 (0 to 6 - normal/symptom absent; 7 to 19 mild depression; 20 to 34 - moderate depression; \\>34 - severe depression)'}, {'measure': 'Montgomery-Asberg Depression Rating Scale (MADRS)', 'timeFrame': 'Follow-up 4 - Day 35', 'description': 'Montgomery-Asberg Depression Rating Scale (MADRS) is a clinician rated ten-item diagnostic questionnaire to measure the severity of depression. The overall score ranges from 0 to 60 (0 to 6 - normal/symptom absent; 7 to 19 mild depression; 20 to 34 - moderate depression; \\>34 - severe depression)'}, {'measure': 'Montgomery-Asberg Depression Rating Scale (MADRS)', 'timeFrame': 'Follow-up 5 - Day 42', 'description': 'Montgomery-Asberg Depression Rating Scale (MADRS) is a clinician rated ten-item diagnostic questionnaire to measure the severity of depression. The overall score ranges from 0 to 60 (0 to 6 - normal/symptom absent; 7 to 19 mild depression; 20 to 34 - moderate depression; \\>34 - severe depression)'}, {'measure': 'Montgomery-Asberg Depression Rating Scale (MADRS)', 'timeFrame': 'Follow-up 6 - Day 49', 'description': 'Montgomery-Asberg Depression Rating Scale (MADRS) is a clinician rated ten-item diagnostic questionnaire to measure the severity of depression. The overall score ranges from 0 to 60 (0 to 6 - normal/symptom absent; 7 to 19 mild depression; 20 to 34 - moderate depression; \\>34 - severe depression)'}, {'measure': 'Montgomery-Asberg Depression Rating Scale (MADRS)', 'timeFrame': 'Follow-up 7 - Day 56', 'description': 'Montgomery-Asberg Depression Rating Scale (MADRS) is a clinician rated ten-item diagnostic questionnaire to measure the severity of depression. The overall score ranges from 0 to 60 (0 to 6 - normal/symptom absent; 7 to 19 mild depression; 20 to 34 - moderate depression; \\>34 - severe depression)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PTSD', 'Ketamine', 'Veteran', 'Military', 'Clinical Trial'], 'conditions': ['PTSD', 'Posttraumatic Stress Disorder']}, 'referencesModule': {'references': [{'pmid': '30999057', 'type': 'BACKGROUND', 'citation': 'Abdallah CG, Roache JD, Averill LA, Young-McCaughan S, Martini B, Gueorguieva R, Amoroso T, Southwick SM, Guthmiller K, Lopez-Roca AL, Lautenschlager K, Mintz J, Litz BT, Williamson DE, Keane TM, Peterson AL, Krystal JH; Consortium to Alleviate PTSD. Repeated ketamine infusions for antidepressant-resistant PTSD: Methods of a multicenter, randomized, placebo-controlled clinical trial. Contemp Clin Trials. 2019 Jun;81:11-18. doi: 10.1016/j.cct.2019.04.009. Epub 2019 Apr 15.'}, {'pmid': '35046508', 'type': 'BACKGROUND', 'citation': "Abdallah CG, Roache JD, Gueorguieva R, Averill LA, Young-McCaughan S, Shiroma PR, Purohit P, Brundige A, Murff W, Ahn KH, Sherif MA, Baltutis EJ, Ranganathan M, D'Souza D, Martini B, Southwick SM, Petrakis IL, Burson RR, Guthmiller KB, Lopez-Roca AL, Lautenschlager KA, McCallin JP 3rd, Hoch MB, Timchenko A, Souza SE, Bryant CE, Mintz J, Litz BT, Williamson DE, Keane TM, Peterson AL, Krystal JH. Dose-related effects of ketamine for antidepressant-resistant symptoms of posttraumatic stress disorder in veterans and active duty military: a double-blind, randomized, placebo-controlled multi-center clinical trial. Neuropsychopharmacology. 2022 Jul;47(8):1574-1581. doi: 10.1038/s41386-022-01266-9. Epub 2022 Jan 19."}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to test the safety and efficacy of repeated doses of ketamine as compared to placebo, in reducing symptoms of Posttraumatic Stress Disorder (PTSD) in an active duty military and Veteran population.', 'detailedDescription': 'In this 2-site clinical trial, intended to evaluate the safety and efficacy of repeated doses of ketamine for treatment resistant PTSD, Veterans and active duty military personnel who meet criteria for PTSD and the additional inclusion and exclusion criteria will be randomized to one of three treatment arms (placebo, low dose ketamine, high dose ketamine). Participants receive the study drug via intravenous infusion twice per week for 4-weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* male or female Veterans or active duty military personnel between the ages of 18 and 70 years\n* diagnosis of PTSD\n* history of trialing one or more antidepressant medications with little to no PTSD symptom improvement\n* ability to provide written informed consent\n\nExclusion Criteria:\n\n* females who are currently pregnant or breastfeeding\n* current high risk for suicide\n* history of severe head injury'}, 'identificationModule': {'nctId': 'NCT02655692', 'briefTitle': 'CAP-Ketamine for Antidepressant Resistant PTSD', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'CAP-Ketamine for Antidepressant Resistant PTSD', 'orgStudyIdInfo': {'id': 'SPLE-003-14W'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Saline dose', 'interventionNames': ['Drug: Placebo/Saline']}, {'type': 'EXPERIMENTAL', 'label': 'Low Dose Ketamine', 'description': 'Low Dose Ketamine (.20 mg/kg)', 'interventionNames': ['Drug: Ketamine']}, {'type': 'EXPERIMENTAL', 'label': 'High Dose Ketamine', 'description': 'High Dose Ketamine (.50 mg/kg)', 'interventionNames': ['Drug: Ketamine']}], 'interventions': [{'name': 'Ketamine', 'type': 'DRUG', 'description': 'FDA approved anesthetic medication with rapid acting antidepressant effects.', 'armGroupLabels': ['High Dose Ketamine', 'Low Dose Ketamine']}, {'name': 'Placebo/Saline', 'type': 'DRUG', 'description': 'This is a saline placebo/non-active solution.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06516', 'city': 'West Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'VA Connecticut Healthcare System West Haven Campus, West Haven, CT', 'geoPoint': {'lat': 41.27065, 'lon': -72.94705}}, {'zip': '55417', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Minneapolis VA Health Care System, Minneapolis, MN', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '78234', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Brooke Army Medical Center', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'John H. Krystal, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VA Connecticut Healthcare System West Haven Campus, West Haven, CT'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VA Office of Research and Development', 'class': 'FED'}, 'collaborators': [{'name': 'The University of Texas Health Science Center at San Antonio', 'class': 'OTHER'}, {'name': 'Brooke Army Medical Center', 'class': 'FED'}, {'name': 'Minneapolis Veterans Affairs Medical Center', 'class': 'FED'}], 'responsibleParty': {'type': 'SPONSOR'}}}}