Back to search results

Ketamine Treatment for PTSD and Depression in TBI

This study is looking at whether ketamine can help Veterans who have both a traumatic brain injury (TBI) and symptoms of depression or post-traumatic stress disorder (PTSD). You might be able to join if you are a Veteran between 18 and 55 years old, have a history of mild to moderate TBI that happened at least 12 weeks ago, and can read and write in English. Participants will receive either intravenous (IV) ketamine or midazolam (an active placebo) twice a week for three weeks. The main goal is to see if ketamine reduces depression symptoms after three weeks and if it is safe. The current status of this study is unclear.

Study design
This interventional study plans to enroll 40 participants. You would be randomly assigned to receive either ketamine or midazolam.
What's involved
You would receive infusions twice a week for three weeks. During this time, you would have interviews, lab tests, and complete questionnaires.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint measures changes in depressive symptoms at 3 weeks, suggesting follow-up during and immediately after the treatment period.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06228391

Ketamine Treatment for PTSD and MDD in TBI

Not Yet Recruiting
PHASE2Ages 18–75InterventionalTreatment
Minneapolis Veterans Affairs Medical Center
~40 participants
Updated 2024-01-29 on ClinicalTrials.gov
What's tested:IV ketamineMidazolam

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Severity of Depressive Symptoms
Measured over 3 weeks

Conditions

PTSD, Post Traumatic Stress Disorder
Major Depressive Disorder
Traumatic Brain Injury

Explore related trials

Post-Traumatic Stress DisorderTraumatic EncephalopathyUnipolar Depression

Where it's being run

1 sites across 1 states
Minnesota1

Who to contact

Paulo Shiroma, MD
[email protected]
612-467-2264
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

Exclusion

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)

What this trial measures

  • Change in Severity of Depressive Symptoms3 weeks

    Total score on the Montgomery- Åsberg Depression Rating Scale , a semi- structured 10-item scale. Range 0-60. Higher values represent worse outcomes. The total score is obtained by summing the severity score of each item.