Intensive 7-day Treatment for PTSD Combining Ketamine With Exposure Therapy (PTSD)
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|ClinicalTrials.gov Identifier: NCT02727998|
Recruitment Status : Recruiting
First Posted : April 5, 2016
Last Update Posted : March 13, 2020
|Condition or disease||Intervention/treatment||Phase|
|Posttraumatic Stress Disorder||Drug: Ketamine Drug: Midazolam||Phase 2|
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 and will undergo an 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Combining Neurobiology and New Learning: Ketamine and Prolonged Exposure: A Potential Rapid Treatment for Post Traumatic Stress Disorder (PTSD)|
|Study Start Date :||December 2015|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2022|
Experimental: Ketamine with prolonged exposure
After the reactivation of the scripted memories during PE on day 2, the ketamine infusion procedure will begin inside the MRI. A physician will oversee and administer the ketamine infusions. A nurse will accompany the subject throughout the study sessions, from the insertion of bilateral cannula for drug infusion and blood sampling, to the recovery following ketamine infusion. Whilst subjects undergo the infusion, their heart rate and blood pressure will be constantly monitored. The participant will receive a steady state ketamine infusion of 0.50 mg/kg/hour. The infusion will continue for 40 minutes.
Prolonged exposure therapy combined with a single infusion of 0.50 mg/kg/hour for 40 min on day 2.
Other Name: Ketalar
Active Comparator: Midazolam with prolonged exposure
After the reactivation of the scripted memories during PE on day 2, the midazolam infusion procedure will begin inside the MRI. A physician will oversee and administer the Midazolam infusions. A nurse will accompany the subject throughout the study sessions, from the insertion of bilateral cannula for drug infusion and blood sampling, to the recovery following midazolam infusion. Whilst subjects undergo the infusion, their heart rate and blood pressure will be constantly monitored. The participant will receive a steady midazolam infusions at a rate 0.045 mg/kg for 40 minutes.
Prolonged exposure therapy combined with a single infusion of 0.045 mg/kg/hour for 40 min on day 2.
Other Name: Versed
- Change from baseline to 90 days post treatment in Clinician-Administered PTSD Scale scores [ Time Frame: Baseline, 7 days, 30 days and 90 days ]Clinician-Administered PTSD Scale for DSM-5 (CAPS-5). A higher score is associated with higher severity of PTSD. The score is interpreted as follows: 0-19=Asymptomatic/few symptoms 20-39=Sub-threshold/mild PTSD 40-59=Threshold PTSD/moderate 60-79=Severe PTSD >80=Extreme PTSD
- Change from baseline to 90 days post treatment in Beck Depression Inventory (BDI-II) [ Time Frame: Baseline, 7 days, 30 days and 90 days ]The self-report BDI-II will be used to assess severity of depressive symptoms. A higher score is associated with higher severity of depression. The score is interpreted as follows: 0-13 indicates minimal depression, 14-19 indicates mild depression, 20-28 indicates moderate depression and 29-63 indicates severe depression
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02727998
|Contact: Ilan Harps-Rotem, PhDfirstname.lastname@example.org|
|Contact: Charles Gordon, MA||203-932-5711 ext email@example.com|
|United States, Connecticut|
|Yale University School of Medicine||Recruiting|
|New Haven, Connecticut, United States, 06510|
|Contact: Ilan Harpaz-Rotem, PhD 203-937-4760 firstname.lastname@example.org|
|Contact: Charles Gordon, MA 203-932-5711 ext 4326 email@example.com|
|Principal Investigator:||Ilan Harpaz-Rotem, PhD||Yale University|