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Ketamine for Traumatic Brain Injury

Phase 2

Waitlist Available

Research Sponsored by Minneapolis Veterans Affairs Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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)

Male or female Veterans aged 18-55 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 weeks

Awards & highlights

Study Summary

This trial is studying the use of a sedative called ketamine to treat depression and post-traumatic stress disorder (PTSD) in Veterans who have had a mild to moderate traumatic brain injury (T

Who is the study for?

This trial is for Veterans with mild to moderate traumatic brain injury (TBI) who are experiencing depression or PTSD. Participants must be able to attend multiple treatment sessions and complete assessments. Specific criteria for inclusion or exclusion were not provided.Check my eligibility

What is being tested?

The study tests if ketamine, given as a sedative, can help reduce symptoms of depression and PTSD in TBI patients compared to midazolam (an active placebo). Treatments are administered twice weekly over three weeks while monitoring through interviews, lab tests, and questionnaires.See study design

What are the potential side effects?

Ketamine may cause side effects such as disorientation, nausea, increased blood pressure, mood changes, hallucinations or dizziness. Midazolam could lead to sleepiness, memory issues or coordination problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I had a mild to moderate brain injury over 12 weeks ago, meeting specific health guidelines.

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I am a Veteran between 18 and 55 years old.

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I have tried at least one antidepressant that didn't work for me.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Severity of Depressive Symptoms

Secondary outcome measures

Change in Severity of Post-traumatic Stress Disorder (PTSD) Symptoms

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: KetamineExperimental Treatment1 Intervention

Twice a week ketamine IV 0.5 mg/kg

Group II: MidazolamActive Control1 Intervention

Twice a week midazolam IV 0.045 mg/kg

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Minneapolis Veterans Affairs Medical CenterLead Sponsor

72 Previous Clinical Trials

14,880 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do I meet the necessary criteria to participate in this research trial?

"To qualify for inclusion in this research, individuals must possess a traumatic brain injury and be within the age bracket of 18 to 75 years. The study aims to recruit a total of 40 participants."

Answered by AI

Is the age bracket for participants in this medical study inclusive of individuals who are 80 years or older?

"Patients aged between 18 and 75 are eligible to participate in this trial, as stated by the inclusion criteria. Interestingly, there are a total of 210 clinical trials available for patients under the age of 18, while there are 1150 trials specifically targeting individuals over the age of 65."

Answered by AI

Are there any available openings for patients to participate in this medical study?

"According to the current information available on clinicaltrials.gov, this particular study is not currently seeking participants. The trial was originally posted on March 1st, 2024 and was last updated on January 26th, 2024. However, it's important to note that there are currently 1536 other studies actively enrolling patients at this time."

Answered by AI

What are the potential risks associated with administering ketamine to patients?

"Based on our assessment at Power, the safety of ketamine in this clinical trial is given a score of 2. This reflects that there is existing data supporting its safety but no evidence yet to support its efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Ketamine Treatment for PTSD and MDD in TBI

Paulo Shiroma 2024. "Ketamine Treatment for PTSD and MDD in TBI". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06228391.

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