Ketamine Treatment for PTSD and MDD in TBI

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

Trial statusNot yet recruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18-75

SponsorMinneapolis Veterans Affairs Medical Center

About 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 does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

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.

Treatment groups

40 Participants

are divided into 2 treatment groups

Group A: KetamineExperimental treatment 1 intervention

Group B: MidazolamActive comparator 1 intervention

Trial outcomes

Primary outcomes

Change in Severity of Depressive Symptoms

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.

Time frame

3 weeks

Secondary outcomes

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

Total score on the PTSD Checklist for DSM-5 (PCL-5), a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. The total score is obtained by summing the score of each item.

Time frame

3 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Minneapolis Veterans Affairs Medical Center

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: