Intensive 7-day Treatment for PTSD Combining Ketamine With Exposure

Status Terminated

Clinical Trial Summary

The purpose of this study is to combine a single infusion of Ketamine with 7-days of trauma focus psychotherapy to relieve post traumatic stress disorder (PTSD) symptoms more effectively. This treatment has the potential to produce a significant therapeutic effect that otherwise would take months to occur.

Clinical Trial Description

Based on the current research findings on the therapeutic effectiveness of trauma focus psychotherapy and of ketamine, combining the two treatments may yield a promising new rapid 7-day treatment for PTSD. As PTSD symptoms' structure is comprised of several unique clusters which include re-experiencing, avoidance, numbing/depression and hypervigilance the investigators hypothesize that by combining Ketamine with prolonged exposure (PE) the investigators can address these symptoms clusters more effectively. This treatment has the potential to produce a significant therapeutic effect that otherwise would take months to occur by tapping on the enhanced neuroplasticity and the antidepressant effect of ketamine (which lasts between 24hrs to 7 days), to promote rapid changes in learning and memory using prolonged exposure therapy within this unique "window of opportunity". During the first visit participants will undergo a clinical interview to establish a PTSD diagnosis and other eligibility criteria. If found eligible participants will be invited to take part in this 7-day rapid treatment trial for PTSD. On the first therapy visits, participants will be educated about the psychological treatment that will be provided and the potential benefit of ketamine to enhance the psychotherapy outcomes. On the second day of the study, participants will receive an infusion of ketamine or placebo and will undergo a magnetic resonance imaging (MRI) scan and will receive the second psychotherapy session. On days 3-6 participants will attend a 60-90 minutes psychotherapy session to address their PTSD symptoms. Day 7 will include another MRI scan and the last psychotherapy session. Participants will be asked to come back for a follow up evaluation of their PTSD symptoms 30 and 90 days post discharge. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02727998
Study type	Interventional
Source	Yale University
Contact
Status	Terminated
Phase	Phase 2
Start date	December 2015
Completion date	November 28, 2021

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Intensive 7-day Treatment for PTSD Combining Ketamine With Exposure Therapy — PTSD

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms