Stress Disorders, Post-TraumaticNCT03947099
Ketamine Infusion Therapy for the Treatment of PTSD in Paramedics
An observational study of Stress Disorders, Post-Traumatic and Anxiety Disorders, run by Klarisana Physician Services PLLC at 1 site in United States.
Trial summary
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 as a result of working in emergency medical services. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Stress Disorders, Post-Traumatic, Anxiety Disorders
- What is being tested?
- Ketamine Hydrochloride
- Type of treatment
- Injection or infusion
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 2 May 2019to 22 Feb 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Adult, Older adult
Study population: Men and women who are trained as paramedics (EMT-P) and have worked in 911 emergency medical service systems for at least five years.
Who may be able to join
- Must have worked as a paramedic (EMT-P) on a 911 prehospital service for at least five years.
- Must be diagnosed with post traumatic stress disorder that happened as a result of working as a paramedic
- Diagnosis must have been made by a mental health professional
- The symptoms of PTSD must be having a significant adverse effect on the subject's life
- Subjects must be able to speak and read English
Who cannot join
- Currently participating in another PTSD treatment program and/or research study
- Diagnosis of psychosis
- Uncontrolled hypertension or a history of heart failure
Trial locations and contacts
1 site in 1 country.
About this study
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 as a result of working in emergency medical services.
Read the detailed description
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.
- Being tested
- Ketamine Hydrochloride
- Keywords
- ketamine, ptsd, depression, prehospital
- Medical subject headings
- Stress Disorders, Post-Traumatic, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketamine HydrochlorideDrug
Participants are treated with six one-hour infusions of ketamine hydrochloride over a three week period in hopes of treating symptoms of PTSD.
What is being measured
The primary outcome is the main question the study is designed to answer.
PHQ-9 Score to assess for symptoms of depression
Assess for an improvement in the Periodic Health Questionnaire nine (PHQ-9) score after a series of six ketamine infusions. The PHQ-9 is a nine question scale followed by a single question that assesses functional impairment. Each of the nine questions are scored on a basis of zero to four. The higher the score the more severe the symptoms of depression are. The highest score is 27 and the lowest is zero.
Measured: three weeks
PCL-5 Score to assess for symptoms of PTSD
Assess for an improvement in the PTSD Checklist for Diagnostic and Statistical Manual version five (PCL-5) score after a series of six ketamine infusions. The PCL-5 is a 20 question scale and each question is scored on a zero to four scale. A higher score indicates more severe symptoms of PTSD. The highest score possible is 80 and the lowest is zero.
Measured: three weeks
Secondary outcomes (1)
Assessment of the experiential impact of ketamine therapy
The investigators seek to determine the role that the experiential (psychedelic) aspect of ketamine plays in the treatment of PTSD. This will utilize the Mystical Experience Questionnaire 30. This is a 30 question screening instrument where each question is scored on a scale of one to five. The maximum score is 150. A higher score indicates that the participant reports a more powerful mystical experience. There is also a single question that asks the participants to rate on a scale of one to five how important they feel the experiential (or psychedelic) aspect of the therapy was to their treatment. Five would indicate that they felt it was an important part of the treatment.
Measured: three weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2019
- Study start2 May 2019
- Primary completion22 Feb 2021
- Study completion22 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Stress Disorders, Post-TraumaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Klarisana Physician Services PLLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Carl J Bonnett, MD, Principal investigator, Klarisana Physician Services PLLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03947099
- Sponsor's protocol ID
- KRP002
- Status last verified
- Feb 2021
- First submitted
- 8 May 2019
- Last updated
- 26 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Luftman K, Aydelotte J, Rix K, Ali S, Houck K, Coopwood TB, Teixeira P, Eastman A, Eastridge B, Brown CV, Davis M. PTSD in those who care for the injured. Injury. 2017 Feb;48(2):293-296. doi: 10.1016/j.injury.2016.11.001. Epub 2016 Nov 10.
PubMed 27871770Jacobowitz W. PTSD in psychiatric nurses and other mental health providers: a review of the literature. Issues Ment Health Nurs. 2013 Nov;34(11):787-95. doi: 10.3109/01612840.2013.824053.
PubMed 24131410Stanley IH, Hom MA, Joiner TE. Suicide mortality among firefighters: Results from a large, urban fire department. Am J Ind Med. 2016 Nov;59(11):942-947. doi: 10.1002/ajim.22587. Epub 2016 May 24.
PubMed 27219513Bing-Canar H, Ranney RM, McNett S, Tran JK, Berenz EC, Vujanovic AA. Alcohol Use Problems, Posttraumatic Stress Disorder, and Suicide Risk Among Trauma-Exposed Firefighters. J Nerv Ment Dis. 2019 Mar;207(3):192-198. doi: 10.1097/NMD.0000000000000947.
PubMed 30724832Abdallah CG, Roache JD, Averill LA, Young-McCaughan S, Martini B, Gueorguieva R, Amoroso T, Southwick SM, Guthmiller K, Lopez-Roca AL, Lautenschlager K, Mintz J, Litz BT, Williamson DE, Keane TM, Peterson AL, Krystal JH; Consortium to Alleviate PTSD. Repeated ketamine infusions for antidepressant-resistant PTSD: Methods of a multicenter, randomized, placebo-controlled clinical trial. Contemp Clin Trials. 2019 Jun;81:11-18. doi: 10.1016/j.cct.2019.04.009. Epub 2019 Apr 15.
PubMed 30999057
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ketamine Infusion Therapy for the Treatment of PTSD in Paramedics
- ClinicalTrials.gov ID
- NCT03947099
- Acronym / sponsor ID
- KRP002
- Keywords
- ketamine, ptsd, depression, prehospital
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Klarisana Physician Services PLLCIndustry (pharma, biotech, devices)
- Study start
- 2 May 2019 (actual)
- Primary completion
- 22 Feb 2021 (actual)
- Study completion
- 22 Feb 2021 (actual)
- First posted
- 13 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 as a result of working in emergency medical services.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Men and women who are trained as paramedics (EMT-P) and have worked in 911 emergency medical service systems for at least five years.
Key inclusion criteria (5 listed)
- Must have worked as a paramedic (EMT-P) on a 911 prehospital service for at least five years.
- Must be diagnosed with post traumatic stress disorder that happened as a result of working as a paramedic
- Diagnosis must have been made by a mental health professional
- The symptoms of PTSD must be having a significant adverse effect on the subject's life
- Subjects must be able to speak and read English
Key exclusion criteria (3 listed)
- Currently participating in another PTSD treatment program and/or research study
- Diagnosis of psychosis
- Uncontrolled hypertension or a history of heart failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ketamine HydrochlorideParticipants are treated with six one-hour infusions of ketamine hydrochloride over a three week period in hopes of treating symptoms of PTSD. | Drug | – |
Primary outcome
PHQ-9 Score to assess for symptoms of depression
Time frame: three weeks
Assess for an improvement in the Periodic Health Questionnaire nine (PHQ-9) score after a series of six ketamine infusions. The PHQ-9 is a nine question scale followed by a single question that assesses functional impairment. Each of the nine questions are scored on a basis of zero to four. The higher the score the more severe the symptoms of depression are. The highest score is 27 and the lowest is zero.
PCL-5 Score to assess for symptoms of PTSD
Time frame: three weeks
Assess for an improvement in the PTSD Checklist for Diagnostic and Statistical Manual version five (PCL-5) score after a series of six ketamine infusions. The PCL-5 is a 20 question scale and each question is scored on a zero to four scale. A higher score indicates more severe symptoms of PTSD. The highest score possible is 80 and the lowest is zero.
1 secondary outcome
Assessment of the experiential impact of ketamine therapy
Time frame: three weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2021.
- Results publication: PubMed 27871770Luftman K, Aydelotte J, Rix K, Ali S, Houck K, Coopwood TB, Teixeira P, Eastman A, Eastridge B, Brown CV, Davis M. PTSD in those who care for the injured. Injury. 2017 Feb;48(2):293-296. doi: 10.1016/j.injury.2016.11.001. Epub 2016 Nov 10.
- Results publication: PubMed 24131410Jacobowitz W. PTSD in psychiatric nurses and other mental health providers: a review of the literature. Issues Ment Health Nurs. 2013 Nov;34(11):787-95. doi: 10.3109/01612840.2013.824053.
- Results publication: PubMed 27219513Stanley IH, Hom MA, Joiner TE. Suicide mortality among firefighters: Results from a large, urban fire department. Am J Ind Med. 2016 Nov;59(11):942-947. doi: 10.1002/ajim.22587. Epub 2016 May 24.
- Results publication: PubMed 30724832Bing-Canar H, Ranney RM, McNett S, Tran JK, Berenz EC, Vujanovic AA. Alcohol Use Problems, Posttraumatic Stress Disorder, and Suicide Risk Among Trauma-Exposed Firefighters. J Nerv Ment Dis. 2019 Mar;207(3):192-198. doi: 10.1097/NMD.0000000000000947.
- Results publication: PubMed 30999057Abdallah CG, Roache JD, Averill LA, Young-McCaughan S, Martini B, Gueorguieva R, Amoroso T, Southwick SM, Guthmiller K, Lopez-Roca AL, Lautenschlager K, Mintz J, Litz BT, Williamson DE, Keane TM, Peterson AL, Krystal JH; Consortium to Alleviate PTSD. Repeated ketamine infusions for antidepressant-resistant PTSD: Methods of a multicenter, randomized, placebo-controlled clinical trial. Contemp Clin Trials. 2019 Jun;81:11-18. doi: 10.1016/j.cct.2019.04.009. Epub 2019 Apr 15.
- The sponsoring treatment facility for this studyLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carl J Bonnett, MD principal investigator
Klarisana Physician Services PLLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stress Disorders, Post-Traumatic and Anxiety Disorders, run by Klarisana Physician Services PLLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PHQ-9 Score to assess for symptoms of depression (time frame: three weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03947099, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2021.