This interventional trial (n=162) aims to evaluate the efficacy of combining ketamine with trauma-focused psychotherapy for treating post-traumatic stress disorder (PTSD) over a week-long period.
Conducted by Yale University, this study seeks to determine whether ketamine, compared to midazolam, enhances the therapeutic effects of psychotherapy in alleviating PTSD symptoms. The treatment involves administering ketamine or midazolam infusions on days 2 and 4, alongside psychotherapy sessions from days 3 to 6. MRI scans will assess brain reactivity to PTSD before and after treatment. Participants will undergo follow-up evaluations at 30 and 90 days post-treatment.
The study aims to explore neurophysiological changes and assess amygdala activation, PTSD symptom severity, task-based connectivity, and psychophysiological distress to trauma reminders. Eligible participants must be between 21-70 years old, have a diagnosis of PTSD, and meet specific inclusion criteria. The trial commenced in August 2023 and is expected to conclude by August 2031.
Trial Details
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Sponsors & Collaborators
Yale UniversityThe Yale Psychedelic Science Group was established in 2016.