Ketamine for PTSD and Depression in TBI

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Minneapolis Veterans Affairs Medical Center

No Placebo Group

Prior Safety Data

Approved in 5 Jurisdictions

Trial Summary

What is the purpose of this trial?

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: * Efficacy of ketamine to reduce symptoms of depression and/or PTSD * Safety of ketamine to treat depression and/or 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.

Eligibility Criteria

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.

Inclusion Criteria

Willingness/able to sign informed consent

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

I have been on a stable dose of certain mental health medications for at least 4 weeks.

Exclusion Criteria

Imminent risk of suicidal/homicidal ideation and/or behavior with intent and/or plan

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)

I have not received ketamine treatment in the past 6 months.

Treatment Details

Interventions

• Ketamine (Other)

Trial Overview 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.

Participant Groups

Group I: Ketamine Experimental Treatment 1 Intervention

Twice a week ketamine IV 0.5 mg/kg

Group II: Midazolam Active Control 1 Intervention

Twice a week midazolam IV 0.045 mg/kg

Ketamine is already approved in United States, European Union, United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as Ketalar for:

• Anesthesia
• Treatment-resistant depression

🇪🇺 Approved in European Union as Ketalar for:

• Anesthesia
• Treatment-resistant depression

🇺🇸 Approved in United States as Spravato for:

• Treatment-resistant depression

🇪🇺 Approved in European Union as Spravato for:

• Treatment-resistant depression

🇨🇦 Approved in Canada as Spravato for:

• Treatment-resistant depression

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Minneapolis VA Medical Center Minneapolis, MN

Who Is Running the Clinical Trial?

Minneapolis Veterans Affairs Medical Center Lead Sponsor

References