RecruitingPhase 2NCT05737693

Enhancing Week-long Psychological Treatment for PTSD With Ketamine

Posttraumatic Stress Disorder (PTSD) Treatment: Using Ketamine to Enhance Memory Reconsolidation and Extinction of Overgeneralized Fear in Individuals Diagnosed With PTSD


Sponsor

Yale University

Enrollment

162 participants

Start Date

Aug 21, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 21 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding a low dose of ketamine (an anesthetic sometimes used for depression) to an intensive one-week therapy program can improve outcomes for people with severe, long-lasting PTSD. **You may be eligible if...** - You are between 21 and 70 years old - You have been diagnosed with chronic PTSD (symptoms lasting more than 1 year) rated as severe on a standard clinical scale - You are able to read and write in English - If you take antidepressants or certain other psychiatric medications, you have been on a stable dose for at least 4 weeks - If female, you are not pregnant and are using an acceptable form of birth control (or are post-menopausal or surgically sterile) **You may NOT be eligible if...** - You have a diagnosis of borderline personality disorder, OCD, schizophrenia, or schizoaffective disorder - You currently have serious, active suicidal thoughts - You have a history of certain heart conditions, uncontrolled blood pressure, or significant substance use that would make ketamine unsafe - You had a manic episode in the 30 days before enrolling Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGKetamine

Week-long exposure therapy with ketamine infusion on day 2 and 4 of the psychotherapy

DRUGMidazolam

Week-long exposure therapy with midazolam infusion on day 2 and 4 of the psychotherapy


Locations(2)

Yale University School of Medicine

New Haven, Connecticut, United States

Tel Aviv University

Tel Aviv, Israel

View Full Details on ClinicalTrials.gov

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NCT05737693


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