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
- Major Depressive Disorder
- PTSD, Post Traumatic Stress Disorder
- Traumatic Brain Injury
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 75 Years
- Healthy Volunteers
- Not accepted
Interventions
- IV ketamine — DRUGSubjects will receive a single infusion of racemic ketamine at 0.5mg/kg for 40 minutes twice a week for 3 weeks.
- Midazolam — DRUGSubjects 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: KetamineTwice a week ketamine IV 0.5 mg/kg
- Active Comparator: MidazolamTwice a week midazolam IV 0.045 mg/kg
Primary Outcome Measure
Change in Severity of Depressive Symptoms [ Time Frame: 3 weeks ]
Central Contacts
- Paulo Shiroma, MD612-467-2264
- Seth Dsiner, PhD612-629-7349
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Minneapolis VA Medical Center | Minneapolis | Minnesota | 55417 | Paulo Shiroma, MD (PRINCIPAL_INVESTIGATOR) |
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