This interventional trial (n=40) aims to investigate the efficacy and safety of subanesthetic ketamine in treating depression and post-traumatic stress disorder (PTSD) among Veterans with mild to moderate traumatic brain injury (TBI).
Participants will be randomly assigned to receive either ketamine or midazolam (active placebo) twice a week for 3 weeks. The study will assess the change in severity of depressive symptoms measured by the Montgomery-Åsberg Depression Rating Scale and the severity of PTSD symptoms measured by the PTSD Checklist for DSM-5.
The study is conducted by the Minneapolis Veterans Affairs Medical Center and is estimated to begin in March 2024 and end in March 2027.
Trial 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.Trial Number NCT06228391
Sponsors & Collaborators
Minneapolis Veterans Affairs Medical CenterThis company doesn't have a full profile yet, it is linked to a clinical trial.
University Hospital Toulouse
The University Hospital of Toulouse (CHU de Toulouse) is a leading medical institution located in Toulouse, France. It provides comprehensive healthcare services, conducts medical research, and offers educational programs for healthcare professionals