Ketamine for Depression and PTSD in Mild–Moderate TBI
Subanesthetic ketamine for depression and PTSD in veterans with mild-to-moderate traumatic brain injury.
This study has a confirmed start but isn't enrolling yet. Check the official page for the recruitment date.
This is an interventional study — the research team administers the treatment under a controlled, IRB-approved protocol. Participation never happens outside that protocol.
- Substance
- Ketamine
- Status
- Upcoming
- Conditions
- PTSD, Depression, TBI
- Who can join
- Veterans only
- Where
- Minneapolis, MN
- Run by
- Minneapolis VA Medical Center
- Registry ID
- NCT06228391 ↗
How to join this study
Call or email the study team directly. You do not go through Psychedelic Vets — we just make the door easier to find.
Contact details as published by the sponsor, last verified 2024-01. People move on — if this doesn't reach anyone, check ClinicalTrials.gov.
What taking part involves
Twice a week ketamine IV 0.5 mg/kg
Twice a week midazolam IV 0.045 mg/kg
Who can join
Listed as the research team wrote them. This is not a decision about you — only the study team can say whether you are eligible, and the only way to find out is to ask them.
What the study is looking for
- Willingness/able to sign informed consent.
- Able to read and write in English.
- Male or female Veterans aged 18-55 years old.
- Remote history of TBI mild-moderate that is ≥12 weeks post-injury (chronic period) that met at minimum the 2021 VA/DoD 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).
- 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).
- 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
What would rule you out
- Ketamine treatment within the last 6 months
- Lifetime history of psychosis-related disorder, current episode of mania/hypomania/mixed assessed by the Mini-International Neuropsychiatric Interview (MINI 7.0 for DSM-5).
- History of penetrating head wounds or severe traumatic brain injury (Glasgow Coma Scale \<9; loss of consciousness \>24hr; post-traumatic amnesia\>7 days).
- Severe substance and/or alcohol use disorder (DSM-5-TR) within six months of initial assessment; presence of illicit drugs (except cannabis) by positive urine toxicology at screening.
- Intellectual disability or pervasive developmental disorder; dementia of any type.
- 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).
- For women: pregnancy (confirmed by lab test), initiation of female hormonal treatments within 3 months of screening, or inability/ 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
- At screening, resting blood pressure (sitting or supine) lower than 90/60 or higher than 150/90, or resting heart rate lower than 45/min or higher than 100/min.
- Imminent risk of suicidal/homicidal ideation and/or behavior with intent and/or plan.
- Concurrent participation in a cognitive rehabilitation program, however patient will have a TBI clinician involved in directed services.
- Subjects on a prohibited medication: monoamine oxidase inhibitors, memantine, long acting benzodiazepines (i.e., Chlordiazepoxide, Diazepam, Flurazepam)
You enroll directly with the research team through their own official page and IRB-approved consent process. Psychedelic Vets does not run this study or collect any of your health information.
Study data is sourced from ClinicalTrials.gov (U.S. National Library of Medicine) and verified university/nonprofit sources. This page is educational and is not medical advice or an endorsement. Details can change — always confirm on the official page above. ← Back to all studies
