We try to understand more about the injury experienced during the war and its impact on mental health, and therefore we initiate research. Our long-term goal is to introduce new methods of treatment of PTSD and anxiety-depressive disorders that are affected by chief and veterans affected during hostilities, and especially those who do not help normal ling.
Together with the public organization "Fund for the development of medicine and psychosocial support” ми розпочали підготовку до клінічного дослідження:
"A single-center, randomized, double-blind, placebo-controlled clinical trial of ketamine-assisted integrative psychotherapy in military personnel with treatment-resistant posttraumatic stress disorder (PTSD)."
Detailed description of the study.
Military veterans diagnosed with treatment-resistant PTSD related to military trauma will participate in the project.
Patients will be recruited through referrals from psychiatrists, as well as through community and veteran organizations. For those who meet the selection criteria, this study will be essentially free treatment using the latest method for 4-5 weeks.
Participants will be divided into experimental and control groups. Both groups will receive almost the same therapy, except for the drug used during psychotherapy. Then the groups will rotate.
The experimental group will receive ketamine 0.5 mg/kg intravenously in combination with psychotherapy twice weekly and one session of integrative psychotherapy between ketamine sessions lasting 50 minutes, and the control group will receive midazolam twice weekly and one session of integrative psychotherapy between ketamine sessions lasting 50 minutes. At the end of the 4-week treatment, patients in the control group who did not show an improvement of more than 20% from the baseline value of severity of post-traumatic symptoms will be transferred to receive ketamine therapy. Patients who receive 4 weeks of integrative therapy using ketamine will be included in a 3-month follow-up period.
Outcome measures will include measures of PTSD, depression and anxiety symptoms, as well as measures of general functioning and quality of life.
Why Ketamine?
Ketamine is a licensed medicinal product and has been widely used worldwide as a short-acting anesthetic and pain reliever for over 40 years. In microdoses, it has a pronounced psychotropic therapeutic effect, which differs from the action of standard doses used in surgical anesthesia.
To date, this is the only drug that demonstrates a high potential for the treatment of pharmacologically resistant depression and PTSD.
In March 2019 The US Food and Drug Administration (FDA) has approved the use of ketamine for the treatment of depression. According to Ronald Duman, professor of psychiatry and neurobiology at Yale University, "The discovery of the rapid therapeutic effect of ketamine in the treatment of resistant depression is the biggest breakthrough in the scientific study of depression since the past half century".
Studies have found that even a single injection of ketamine usually has a significant and rapid antidepressant effect in patients with persistent depression that is unresponsive to other medications. Several reviews and meta-studies of 10 to 14 studies that used ketamine for PTSD, involving a total of 1,107 patients, found that the drug can significantly improve chronic PTSD symptoms.
Repeated injections of ketamine are safe in patients with chronic PTSD and are generally well tolerated with short-term adverse psychiatric and hemodynamic effects. The combination of ketamine with psychotherapy is especially effective.
The data of foreign clinical studies indicate the significant expediency of introducing this method into national treatment protocols. This point of view is also supported by the Public Health Center of the Ministry of Health of Ukraine, which recommended conducting a domestic clinical study to demonstrate the effectiveness of the method in PTSD. The obtained results can become the basis for the implementation of this technique at the state level.
Participation
We invite active or former military personnel (veterans) of any gender, ages 18 to 55, who have experienced psychological trauma and meet the diagnostic criteria for treatment-resistant PTSD to participate.
For those who meet the participation criteria, this study will essentially be free treatment using the latest method within 4-5 weeks.
What will you have to do?
– Provide us with your contact details (such as address, email address and telephone number) and some personal information (such as date of birth, marital status and medical history).
- to give an informed consent to the study.
- Provide answers to psychological questionnaires. It will take approximately 45 minutes.
- Pass a medical examination and pass a series of tests at the beginning and at the end of the study.
- to come for treatment at the medical center of Expio three times a week, being in it for about 2 - 3 hours (day hospital conditions).
- To allow us to contact you every 3-6-12 months to ask you to provide more information about your mental and physical health and lifestyle. This is necessary to understand the long-term effects of a new treatment method.
- Allow us to share anonymous information with other researchers and organizations if they have scientific and ethical approval for the questions they would like to answer. However, we would like to emphasize that these organizations will never have access to your personal/identifying information (eg your name, address, date of birth).
All information collected during the study will be kept strictly confidential. Only the research team will have access to your data and only they will contact you directly.
Review and ethical approval of the study was obtained from the ethical committee of the "Ukrainian Institute of Public Health Policy".
If you are ready to participate in this study, please fill in the application form below. If you have additional questions, ask them to the research team in our center by number 07373 080 88.
We invite sponsors, philanthropists and activists to support our study of the latest treatments for trauma! Make a devour HERE.