Stress Disorders, Post-TraumaticNCT03088384
Ketamine Infusion Therapy for PTSD in Combat Veterans
An observational study of Stress Disorders, Post-Traumatic, run by Klarisana Physician Services PLLC at 1 site in United States.
Trial summary
Klarisana is conducting an observational study in San Antonio, Texas to see if there are tangible improvements in the symptoms of post traumatic stress disorder (PTSD) in combat veterans after receiving a series of six low-dose outpatient infusions of ketamine. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress Disorders, Post-Traumatic
- What is being tested?
- Ketamine
- Type of treatment
- Injection or infusion
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Nov 2016to 29 Sep 2018
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Veterans of the United States or foreign militaries who have served in combat and who now suffer from post traumatic stress disorder as a result of that military service.
Who may be able to join
- The Veteran must be medically screened by Klarisana and be an appropriate candidate for ketamine therapy
- The Veteran must be between the ages of 18 and 75. The study is open to men and women.
- The Veteran must be able to speak and read the English language
- The Veteran must have a diagnosis of post-traumatic stress disorder assigned by the Department of Veterans Affairs. Veterans of a foreign military are also eligible but they must have been diagnosed with PTSD by the equivalent veteran healthcare organization in their country of military service
- The Veteran must have served in the US Military or a foreign military service in a designated combat zone. Documentation by a DD214 or equivalent is required
- The PTSD that The Veteran is suffering from has to have been caused by service in combat
- The PTSD that the Veteran is suffering from must be exerting a significant negative effect on his/her life
Who cannot join
- The Veteran must NOT be taking lamotrigine (Lamictal) or any monoamine oxidase inhibitor antidepressants
- The Veteran must not be currently enrolled in any other studies offering therapy for PTSD
- Veteran may NOT have uncontrolled blood pressure or congestive heart failure
- Veteran may NOT have a diagnosis of psychosis or any diagnosis on the psychosis spectrum
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Therapeutic Ketamine Infusions on the Symptoms of Post-Traumatic Stress Disorder in Combat Veterans
Klarisana is conducting an observational study in San Antonio, Texas to see if there are tangible improvements in the symptoms of post traumatic stress disorder (PTSD) in combat veterans after receiving a series of six low-dose outpatient infusions of ketamine.
Read the detailed description
The prolonged conflicts in Iraq and Afghanistan have created a very large population of veterans who suffer from severe post traumatic stress disorder (PTSD). This has, in part, contributed to a rate of suicide that many clinicians and concerned citizens find alarming. In the last two decades, there has been some promising evidence coming to light showing that the medication ketamine can potentially suppress and/or alleviate some of the disturbing symptoms of PTSD such as hypervigilance, anxiety, anger, and recurrent nightmares. If ketamine could be shown to be be a valuable treatment option for PTSD then this could have potentially large positive ramifications for the treatment of PTSD in America's veteran population.
Ketamine has historically been used as a dissociative anesthetic in emergency departments, operating rooms, and in austere military environments. It is a proven medication with a reassuring safety profile. This current study seeks to add to the body of knowledge regarding ketamine therapy by specifically looking at the combat veteran population. Eligible veterans will undergo the standard six-infusion Induction Series of ketamine infusions at Klarisana in San Antonio, Texas. Klarisana is a healthcare center which offers outpatient ketamine infusion therapy for the treatment of severe depression, PTSD, and various chronic pain conditions such as rheumatoid arthritis, fibromyalgia, neuropathy, and migraine headaches. Klarisana serves patients from all over south Texas including Austin, Houston, San Antonio, and Corpus Christi.
Patients who enroll in the current PTSD study will receive a standard battery of survey instruments which Klarisana implements before and after a series of infusions. These instruments will assess each patient's level of depression, degree of PTSD symptoms, as well as their use of alcohol and recreational drugs. The specific instruments are the...
Patient Health Questionnaire (PHQ-9) PTSD Checklist (PCL-5) Drug Abuse Screening Test (DAST-10) Alcohol Use Disorders Identification Test (AUDIT)
The investigator's goal is to formally analyze what changes may occur the participants' symptoms of PTSD and try to better establish the role which ketamine infusion therapy may play in the treatment of PTSD in the combat veteran population.
- Conditions
- Stress Disorders, Post-Traumatic
- Being tested
- Ketamine
- Keywords
- Post Traumatic Stress Disorder, PTSD, Combat Trauma
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
Psychological survey instruments administered before and after a series of six low-dose infusions of ketamine.
| Study group | Role | What they receive |
|---|---|---|
| Combat Veterans | Eligible participants must be military veterans who have served in a combat zone as evidenced by documentation on the subject's DD214 (or equivalent if he/she served in a foreign military). Participants must have a diagnosis of post traumatic stress disorder that was as a result of their military combat experience. Receives: Drug: Ketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant score on the PTSD Checklist - 5 (PCL-5) after a series of six ketamine infusions.
The PCL-5 is a twenty question survey instrument which is used to quantify the level of symptomatology in participants with post-traumatic stress disorder.
Measured: 3 weeks
Secondary outcomes (3)
Participant score on the Patient Health Questionnaire - 9 (PHQ-9) after a series of six ketamine infusions.
The PHQ-9 is a nine-question survey instrument which is used to quantify the level of depressive symptoms in participants.
Measured: 3 weeks
Participant score on the Drug Abuse Screening Test (DAST-10) after a series of six ketamine infusions.
The DAST-10 is a ten-question self-report survey instrument which is used to assess participants' use of illicit drugs.
Measured: 3 weeks
Participant score on the Alcohol Use Disorders Identification Test (AUDIT) after a series of six ketamine infusions.
The AUDIT is a ten-question self-reporting survey instrument which is used to identify participants' use of and potential dependence on alcohol
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2017
- Study start28 Nov 2016
- Primary completion27 Sep 2018
- Study completion29 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)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
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Klarisana Physician Services PLLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03088384
- Sponsor's protocol ID
- KRP001
- Status last verified
- Sep 2018
- First submitted
- 26 Feb 2017
- Last updated
- 2 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Feder A, Parides MK, Murrough JW, Perez AM, Morgan JE, Saxena S, Kirkwood K, Aan Het Rot M, Lapidus KA, Wan LB, Iosifescu D, Charney DS. Efficacy of intravenous ketamine for treatment of chronic posttraumatic stress disorder: a randomized clinical trial. JAMA Psychiatry. 2014 Jun;71(6):681-8. doi: 10.1001/jamapsychiatry.2014.62.
PubMed 24740528Murrough JW, Soleimani L, DeWilde KE, Collins KA, Lapidus KA, Iacoviello BM, Lener M, Kautz M, Kim J, Stern JB, Price RB, Perez AM, Brallier JW, Rodriguez GJ, Goodman WK, Iosifescu DV, Charney DS. Ketamine for rapid reduction of suicidal ideation: a randomized controlled trial. Psychol Med. 2015 Dec;45(16):3571-80. doi: 10.1017/S0033291715001506. Epub 2015 Aug 12.
PubMed 26266877McGowan JC, LaGamma CT, Lim SC, Tsitsiklis M, Neria Y, Brachman RA, Denny CA. Prophylactic Ketamine Attenuates Learned Fear. Neuropsychopharmacology. 2017 Jul;42(8):1577-1589. doi: 10.1038/npp.2017.19. Epub 2017 Jan 27.
PubMed 28128336Brachman RA, McGowan JC, Perusini JN, Lim SC, Pham TH, Faye C, Gardier AM, Mendez-David I, David DJ, Hen R, Denny CA. Ketamine as a Prophylactic Against Stress-Induced Depressive-like Behavior. Biol Psychiatry. 2016 May 1;79(9):776-786. doi: 10.1016/j.biopsych.2015.04.022. Epub 2015 May 4.
PubMed 26037911Burbiel JC. Primary prevention of posttraumatic stress disorder: drugs and implications. Mil Med Res. 2015 Oct 26;2:24. doi: 10.1186/s40779-015-0053-2. eCollection 2015.
PubMed 26504586Fortea A, Espinosa L, Oliveras C, Bruguera P, Benabarre A. Ketamine associated with electroconvulsive therapy for treatment-resistant depression in the elderly: Two case reports. Rev Psiquiatr Salud Ment. 2017 Apr-Jun;10(2):125-126. doi: 10.1016/j.rpsm.2016.12.001. Epub 2017 Feb 10. No abstract available. English, Spanish.
PubMed 28209259Witkin JM, Mitchell SN, Wafford KA, Carter G, Gilmour G, Li J, Eastwood BJ, Overshiner C, Li X, Rorick-Kehn L, Rasmussen K, Anderson WH, Nikolayev A, Tolstikov VV, Kuo MS, Catlow JT, Li R, Smith SC, Mitch CH, Ornstein PL, Swanson S, Monn JA. Comparative Effects of LY3020371, a Potent and Selective Metabotropic Glutamate (mGlu) 2/3 Receptor Antagonist, and Ketamine, a Noncompetitive N-Methyl-d-Aspartate Receptor Antagonist in Rodents: Evidence Supporting the Use of mGlu2/3 Antagonists, for the Treatment of Depression. J Pharmacol Exp Ther. 2017 Apr;361(1):68-86. doi: 10.1124/jpet.116.238121. Epub 2017 Jan 30.
PubMed 28138040Murrough JW, Burdick KE, Levitch CF, Perez AM, Brallier JW, Chang LC, Foulkes A, Charney DS, Mathew SJ, Iosifescu DV. Neurocognitive effects of ketamine and association with antidepressant response in individuals with treatment-resistant depression: a randomized controlled trial. Neuropsychopharmacology. 2015 Mar 13;40(5):1084-90. doi: 10.1038/npp.2014.298.
PubMed 25374095
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Therapeutic Ketamine Infusions on the Symptoms of Post-Traumatic Stress Disorder in Combat Veterans
- ClinicalTrials.gov ID
- NCT03088384
- Acronym / sponsor ID
- KRP001
- Conditions
- Stress Disorders, Post-Traumatic
- Keywords
- Post Traumatic Stress Disorder, PTSD, Combat Trauma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Klarisana Physician Services PLLCIndustry (pharma, biotech, devices)
- Study start
- 28 Nov 2016 (actual)
- Primary completion
- 27 Sep 2018 (actual)
- Study completion
- 29 Sep 2018 (actual)
- First posted
- 23 Mar 2017 (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.
Klarisana is conducting an observational study in San Antonio, Texas to see if there are tangible improvements in the symptoms of post traumatic stress disorder (PTSD) in combat veterans after receiving a series of six low-dose outpatient infusions of ketamine.
Detailed description
The prolonged conflicts in Iraq and Afghanistan have created a very large population of veterans who suffer from severe post traumatic stress disorder (PTSD). This has, in part, contributed to a rate of suicide that many clinicians and concerned citizens find alarming. In the last two decades, there has been some promising evidence coming to light showing that the medication ketamine can potentially suppress and/or alleviate some of the disturbing symptoms of PTSD such as hypervigilance, anxiety, anger, and recurrent nightmares. If ketamine could be shown to be be a valuable treatment option for PTSD then this could have potentially large positive ramifications for the treatment of PTSD in America's veteran population.
Ketamine has historically been used as a dissociative anesthetic in emergency departments, operating rooms, and in austere military environments. It is a proven medication with a reassuring safety profile. This current study seeks to add to the body of knowledge regarding ketamine therapy by specifically looking at the combat veteran population. Eligible veterans will undergo the standard six-infusion Induction Series of ketamine infusions at Klarisana in San Antonio, Texas. Klarisana is a healthcare center which offers outpatient ketamine infusion therapy for the treatment of severe depression, PTSD, and various chronic pain conditions such as rheumatoid arthritis, fibromyalgia, neuropathy, and migraine headaches. Klarisana serves patients from all over south Texas including Austin, Houston, San Antonio, and Corpus Christi.
Patients who enroll in the current PTSD study will receive a standard battery of survey instruments which Klarisana implements before and after a series of infusions. These instruments will assess each patient's level of depression, degree of PTSD symptoms, as well as their use of alcohol and recreational drugs. The specific instruments are the...
Patient Health Questionnaire (PHQ-9) PTSD Checklist (PCL-5) Drug Abuse Screening Test (DAST-10) Alcohol Use Disorders Identification Test (AUDIT)
The investigator's goal is to formally analyze what changes may occur the participants' symptoms of PTSD and try to better establish the role which ketamine infusion therapy may play in the treatment of PTSD in the combat veteran population.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Combat Veterans | – | Drug: KetamineEligible participants must be military veterans who have served in a combat zone as evidenced by documentation on the subject's DD214 (or equivalent if he/she served in a foreign military). Participants must have a diagnosis of post traumatic stress disorder that was as a result of their military combat experience. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Veterans of the United States or foreign militaries who have served in combat and who now suffer from post traumatic stress disorder as a result of that military service.
Key inclusion criteria (7 listed)
- The Veteran must be medically screened by Klarisana and be an appropriate candidate for ketamine therapy
- The Veteran must be between the ages of 18 and 75. The study is open to men and women.
- The Veteran must be able to speak and read the English language
- The Veteran must have a diagnosis of post-traumatic stress disorder assigned by the Department of Veterans Affairs. Veterans of a foreign military are also eligible but they must have been diagnosed with PTSD by the equivalent veteran healthcare organization in their country of military service
- The Veteran must have served in the US Military or a foreign military service in a designated combat zone. Documentation by a DD214 or equivalent is required
Key exclusion criteria (4 listed)
- The Veteran must NOT be taking lamotrigine (Lamictal) or any monoamine oxidase inhibitor antidepressants
- The Veteran must not be currently enrolled in any other studies offering therapy for PTSD
- Veteran may NOT have uncontrolled blood pressure or congestive heart failure
- Veteran may NOT have a diagnosis of psychosis or any diagnosis on the psychosis spectrum
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 |
|---|---|---|
| KetaminePsychological survey instruments administered before and after a series of six low-dose infusions of ketamine. | Drug | Combat Veterans |
Primary outcome
Participant score on the PTSD Checklist - 5 (PCL-5) after a series of six ketamine infusions.
Time frame: 3 weeks
The PCL-5 is a twenty question survey instrument which is used to quantify the level of symptomatology in participants with post-traumatic stress disorder.
3 secondary outcomes
Participant score on the Patient Health Questionnaire - 9 (PHQ-9) after a series of six ketamine infusions.
Time frame: 3 weeks
Participant score on the Drug Abuse Screening Test (DAST-10) after a series of six ketamine infusions.
Time frame: 3 weeks
Participant score on the Alcohol Use Disorders Identification Test (AUDIT) after a series of six ketamine infusions.
Time frame: 3 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 2 Oct 2018.
- Background: PubMed 24740528Feder A, Parides MK, Murrough JW, Perez AM, Morgan JE, Saxena S, Kirkwood K, Aan Het Rot M, Lapidus KA, Wan LB, Iosifescu D, Charney DS. Efficacy of intravenous ketamine for treatment of chronic posttraumatic stress disorder: a randomized clinical trial. JAMA Psychiatry. 2014 Jun;71(6):681-8. doi: 10.1001/jamapsychiatry.2014.62.
- Background: PubMed 26266877Murrough JW, Soleimani L, DeWilde KE, Collins KA, Lapidus KA, Iacoviello BM, Lener M, Kautz M, Kim J, Stern JB, Price RB, Perez AM, Brallier JW, Rodriguez GJ, Goodman WK, Iosifescu DV, Charney DS. Ketamine for rapid reduction of suicidal ideation: a randomized controlled trial. Psychol Med. 2015 Dec;45(16):3571-80. doi: 10.1017/S0033291715001506. Epub 2015 Aug 12.
- Background: PubMed 28128336McGowan JC, LaGamma CT, Lim SC, Tsitsiklis M, Neria Y, Brachman RA, Denny CA. Prophylactic Ketamine Attenuates Learned Fear. Neuropsychopharmacology. 2017 Jul;42(8):1577-1589. doi: 10.1038/npp.2017.19. Epub 2017 Jan 27.
- Background: PubMed 26037911Brachman RA, McGowan JC, Perusini JN, Lim SC, Pham TH, Faye C, Gardier AM, Mendez-David I, David DJ, Hen R, Denny CA. Ketamine as a Prophylactic Against Stress-Induced Depressive-like Behavior. Biol Psychiatry. 2016 May 1;79(9):776-786. doi: 10.1016/j.biopsych.2015.04.022. Epub 2015 May 4.
- Background: PubMed 26504586Burbiel JC. Primary prevention of posttraumatic stress disorder: drugs and implications. Mil Med Res. 2015 Oct 26;2:24. doi: 10.1186/s40779-015-0053-2. eCollection 2015.
- Background: PubMed 28209259Fortea A, Espinosa L, Oliveras C, Bruguera P, Benabarre A. Ketamine associated with electroconvulsive therapy for treatment-resistant depression in the elderly: Two case reports. Rev Psiquiatr Salud Ment. 2017 Apr-Jun;10(2):125-126. doi: 10.1016/j.rpsm.2016.12.001. Epub 2017 Feb 10. No abstract available. English, Spanish.
- Background: PubMed 28138040Witkin JM, Mitchell SN, Wafford KA, Carter G, Gilmour G, Li J, Eastwood BJ, Overshiner C, Li X, Rorick-Kehn L, Rasmussen K, Anderson WH, Nikolayev A, Tolstikov VV, Kuo MS, Catlow JT, Li R, Smith SC, Mitch CH, Ornstein PL, Swanson S, Monn JA. Comparative Effects of LY3020371, a Potent and Selective Metabotropic Glutamate (mGlu) 2/3 Receptor Antagonist, and Ketamine, a Noncompetitive N-Methyl-d-Aspartate Receptor Antagonist in Rodents: Evidence Supporting the Use of mGlu2/3 Antagonists, for the Treatment of Depression. J Pharmacol Exp Ther. 2017 Apr;361(1):68-86. doi: 10.1124/jpet.116.238121. Epub 2017 Jan 30.
- Background: PubMed 25374095Murrough JW, Burdick KE, Levitch CF, Perez AM, Brallier JW, Chang LC, Foulkes A, Charney DS, Mathew SJ, Iosifescu DV. Neurocognitive effects of ketamine and association with antidepressant response in individuals with treatment-resistant depression: a randomized controlled trial. Neuropsychopharmacology. 2015 Mar 13;40(5):1084-90. doi: 10.1038/npp.2014.298.
- For more information on the study sponsor - KlarisanaLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Stress Disorders, Post-Traumatic
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Not yet recruiting
A Transdiagnostic Sleep Health Intervention for Veterans With PTSD
Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders
Not yet recruitingPhase 3
Women Who Are Victims of Violence: Treatment of PTSD Through Reactivation of Traumatic Memories Using Propranolol
Post-Traumatic Stress Disorder, PTSD
RecruitingPhase 4
The Effects of Orexin Antagonism on Fear Extinction in PTSD
Insomnia, PTSD
Recruiting
Advancing Skills Through Consultation, Education, and Novel Technologies
PTSD - Post Traumatic Stress Disorder
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.
The record lists no contact. Use the official record to reach the sponsor.
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, 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 7 inclusion and 4 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 2 Oct 2018. 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?
Participant score on the PTSD Checklist - 5 (PCL-5) after a series of six ketamine infusions. (time frame: 3 weeks). 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 NCT03088384, which also lists 8 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 2 Oct 2018.