Ketamine Treatment for PTSD and MDD in TBI

Part of paid clinical trials in Minneapolis, Minnesota.

Sponsor
Minneapolis Veterans Affairs Medical Center
Study ID
NCT06228391
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • IV ketamine — DRUG
    Subjects will receive a single infusion of racemic ketamine at 0.5mg/kg for 40 minutes twice a week for 3 weeks.
  • Midazolam — DRUG
    Subjects will receive a single infusion of midazolam at 0.045mg/kg for 40 minutes twice a week for 3 weeks.

Study Details

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.

Key Dates

Start date
Mar 31, 2024
Status verified
Jan 2024
Primary completion
Dec 31, 2026
Completion
Mar 31, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Ketamine
    Twice a week ketamine IV 0.5 mg/kg
  • Active Comparator: Midazolam
    Twice a week midazolam IV 0.045 mg/kg

Primary Outcome Measure

Change in Severity of Depressive Symptoms [ Time Frame: 3 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Minneapolis VA Medical CenterMinneapolisMinnesota55417
Paulo Shiroma, MD
612-467-2264
Paulo Shiroma, MD (PRINCIPAL_INVESTIGATOR)

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