[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100533636":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":30,"locations":40,"responsibleParty":58,"collaborators":26,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":26,"eligibilityCriteria":67,"healthyVolunteers":63,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":26,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":82,"overallStatus":87,"whyStopped":26,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Minneapolis Veterans Affairs Medical Center","FED",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Ketamine","EXPERIMENTAL","Twice a week ketamine IV 0.5 mg\u002Fkg",[13],"Drug: IV ketamine",{"label":15,"type":16,"description":17,"interventionNames":18},"Midazolam","ACTIVE_COMPARATOR","Twice a week midazolam IV 0.045 mg\u002Fkg",[19],"Drug: Midazolam",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","IV ketamine","Subjects will receive a single infusion of racemic ketamine at 0.5mg\u002Fkg for 40 minutes twice a week for 3 weeks.",[9],null,{"type":22,"name":15,"description":28,"armGroupLabels":29,"otherNames":26},"Subjects will receive a single infusion of midazolam at 0.045mg\u002Fkg for 40 minutes twice a week for 3 weeks.",[15],[31,36],{"name":32,"role":33,"phone":34,"phoneExt":26,"email":35},"Paulo Shiroma, MD","CONTACT","612-467-2264","paulo.shiroma@va.gov",{"name":37,"role":33,"phone":38,"phoneExt":26,"email":39},"Seth Dsiner, PhD","612-629-7349","seth.disner@va.gov",[41],{"facility":42,"status":26,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Minneapolis VA Medical Center","Minneapolis","Minnesota","55417","United States","US",{"type":49,"coordinates":50},"Point",[51,52],-93.26384,44.97997,{"lat":52,"lon":51},[55,56],{"name":32,"role":33,"phone":34,"phoneExt":26,"email":35},{"name":32,"role":57,"phone":26,"phoneExt":26,"email":26},"PRINCIPAL_INVESTIGATOR",{"type":57,"investigatorFullName":59,"investigatorTitle":60,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Paulo Shiroma","Psychiatrist","100533636","phase-2-ketamine-treatment-for-ptsd-and-mdd-in-tbi-100533636",false,"NCT06228391","Ketamine Treatment for PTSD and MDD in TBI","Examining the Efficacy and Safety of Subanesthetic Ketamine on Depression and Post-traumatic Stress Among Veterans With Mild and Moderate Traumatic Brain Injury","Inclusion Criteria:\n\n* Willingness\u002Fable to sign informed consent.\n* Able to read and write in English.\n* Male or female Veterans aged 18-55 years old.\n* Remote history of TBI mild-moderate that is ≥12 weeks post-injury (chronic period) that met at minimum the 2021 VA\u002FDoD Clinical Practice Guideline for the Management and Rehabilitation of Post-Acute Mild Traumatic Brain Injury (i.e., new onset or worsening of at least one of the following clinical signs immediately following the event: loss or decreased of consciousness, period of posttraumatic amnesia, period of being dazed and confused, and neurologic deficits).\n* Lifetime history of treatment resistance to at least one adequate trial of an antidepressant as determined by the Massachusetts General Hospital Antidepressant Treatment History Questionnaire (MGH-ATRQ).\n* FDA-approved antidepressant, trazodone, atypical neuroleptic, prazosin, or clonidine with stable treatment, as determined by the study clinician, for at least 4 weeks prior to randomization. Following randomization, changes to doses may be allowable at the investigator's discretion\n\nExclusion Criteria:\n\n* Ketamine treatment within the last 6 months\n\n  * Lifetime history of psychosis-related disorder, current episode of mania\u002Fhypomania\u002Fmixed assessed by the Mini-International Neuropsychiatric Interview (MINI 7.0 for DSM-5).\n  * History of penetrating head wounds or severe traumatic brain injury (Glasgow Coma Scale \\<9; loss of consciousness \\>24hr; post-traumatic amnesia\\>7 days).\n  * Severe substance and\u002For alcohol use disorder (DSM-5-TR) within six months of initial assessment; presence of illicit drugs (except cannabis) by positive urine toxicology at screening.\n  * Intellectual disability or pervasive developmental disorder; dementia of any type.\n  * Any disorder that, based on the Principal Investigator\\'s judgement, would increase risk (e.g., unstable cardiac conditions) or protocol adherence (e.g., severe personality disorder).\n  * For women: pregnancy (confirmed by lab test), initiation of female hormonal treatments within 3 months of screening, or inability\u002F unwillingness to use a medically accepted contraceptive method during the study. Women who are surgically sterile or have been post-menopausal for at least 1 year will not be excluded\n  * At screening, resting blood pressure (sitting or supine) lower than 90\u002F60 or higher than 150\u002F90, or resting heart rate lower than 45\u002Fmin or higher than 100\u002Fmin.\n  * Imminent risk of suicidal\u002Fhomicidal ideation and\u002For behavior with intent and\u002For plan.\n  * Concurrent participation in a cognitive rehabilitation program, however patient will have a TBI clinician involved in directed services.\n  * Subjects on a prohibited medication: monoamine oxidase inhibitors, memantine, long acting benzodiazepines (i.e., Chlordiazepoxide, Diazepam, Flurazepam)","ALL","18 Years","75 Years",{"count":72,"type":73},40,"ESTIMATED","INTERVENTIONAL",[76],"PHASE2","The goal of this clinical trial is to examine the use of sedative ketamine to treat depression and post-traumatic stress disorder (PTSD) in Veterans with mild to moderate traumatic brain injury (TBI). The main questions it aims to answer are:\n\n* Efficacy of ketamine to reduce symptoms of depression and\u002For PTSD\n* Safety of ketamine to treat depression and\u002For PTSD in TBI Participants will be randomly assigned to receive either ketamine or midazolam (active placebo) twice a week for 3 weeks. During participation, subjects will be interviewed, have lab tests, and complete rating scales, and questionnaires.",[79,80,81],"PTSD, Post Traumatic Stress Disorder","Major Depressive Disorder","Traumatic Brain Injury",[83,9,84,85,86],"Veteran","PTSD","Depression","TBI","NOT_YET_RECRUITING","2024-01-26",{"date":90,"type":91},"2024-01-29","ACTUAL",{"date":93,"type":73},"2024-03",{"date":95,"type":73},"2027-03",{"name":5,"class":6},1]