This is an observational study to assess the change in several psychological screening tools before and after a series of six ketamine infusions in paramedics who suffer from post traumatic stress disorder (PTSD) as a result of working in emergency medical services.
Country United States of America
Visit trial
Status
Completed
Results Published
No
Start date
02 May 2019
End date
22 February 2021
Chance of happening
100%
Phase
Not Applicable
Design
Open
Type
Interventional
Generation
First
Participants
7
Sex
All
Age
18- 75
Therapy
No
Trial Details
Working as a paramedic in a prehospital emergency medical services system (EMS) has been shown to lead to increased incidence of post traumatic stress disorder (PTSD) and increased risk of suicide in prehospital personnel. In recent years a growing body of literature has shown that ketamine hydrochloride can be an effective treatment for PTSD. This study seeks to look specifically at paramedic level emergency medical technicians ("paramedics") with PTSD related to their prehospital work and assess whether ketamine infusion therapy can be an effective treatment for them. This is an observational study where the results of psychological screening tools that are administered before and after a six-infusion series are reported. Additionally the same assessment tools will be administered again 30 days after the final treatment to measure the durability of any changes. The participants will receive the Periodic Health Questionnaire-9 (PHQ-9), the PTSD Checklist for Diagnostic and Statistical Manual, DSM-5 (PCL-5), the Alcohol Use Disorders Identification Test (AUDIT), and the Beck Anxiety Inventory (BAI) before the infusions, after the series of six, and thirty days later. Additionally, after the series of six infusions, participants will receive the Revised Mystical Experience Questionnaire-30 (RMEQ-30) and a one question survey to assess the impact of the experiential aspect of ketamine.NCT Number NCT03947099
Sponsors & Collaborators
Klarisana Physician ServicesThis company doesn't have a full profile yet, it is linked to a clinical trial.
Measures Used
Patient Health Questionnaire for DepressionThe PHQ-9 is the module of the Patient Health Questionnaire focusing on major depressive disorder (MDD). It is a 3-page questionnaire that can be entirely self-administered by the patient, after which it is checked by a medical professional. The PHQ-9 consists of 9 items. If 5 or more criteria have been met, the patient is diagnosed with depression.