Enhancing Week-long Psychological Treatment for PTSD With Ketamine

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.

Topic PTSD
Compound Ketamine
Country United States of America
Visit trial
Status Recruiting
Results Published No
Start date 21 August 2023
End date 01 August 2031
Phase Phase II
Design Blinded
Type Interventional
Generation First
Participants 162
Sex All
Age 21- 70
Therapy Yes

Trial Details

The purpose of this study is to test if the combination of ketamine, vs midazolam, with an intensive trauma-focused psychotherapy will be more effective in relieving post-traumatic stress disorder (PTSD). This week-long treatment has the potential to produce a significant therapeutic effect that otherwise would take months to occur. The study will also focus on learning about the neurophysiological changes produced by the proposed clinical trial.

NCT Number NCT05737693

Sponsors & Collaborators

Yale University
The Yale Psychedelic Science Group was established in 2016.

Data attribution

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