Clinical study of the treatment of depression and existential distress of patients diagnosed with cancer.

Can psychedelics treat depression?

Can they bring relief to people approaching the end of their life?

How do individual psychedelics differ in therapeutic effects?

How long does their healing effect last? How effective are psychedelics in reality compared to classic antidepressants?

The answers to these questions can be found in two PSIKET scientific projects. Under the assurance and direction of  the National Institute of Mental Health – known psychedelic substances are evaluated and compared in terms of their effects on people suffering from severe depression and a group of cancer patients suffering from a mental illness on the basis of their diagnosis. Two substances are the subject of research:

  • psilocybin – the active substance of psychedelic mushrooms
  • ketamine – dissociative anaesthetic

The projects examine in detail the mechanism of psilocybin and the speed of onset of its antidepressant effect and compare the results with the effect of ketamine.

If the research team's expectations are confirmed, the results of these studies will lead to a highly valuable expansion of the available treatment options for depression. They can also be used in palliative care for patients with cancer, who can significantly profit from them and find mental peace. It is this area that gives the research an extraordinary ethical accent - we consider the potential last moments of life spent in inner peace with oneself to be one of the biggest challenges for each of us.

Revolutionary treatment of patients with depression and existential distress in cancer patients

Current clinical studies provide convincing evidence that psychedelic-assisted psychotherapy brings dramatic relief to both people suffering from severe depression and those in palliative care. End-of-life distress in the form of deep depression accompanies up to 40% of cancer patients according to research. People suffering from frequent depressive states or those at the very end of their life journey are often plagued by unpleasant emotions for which it is often very difficult to find a cure. The standard remedies usually do not help much. The health conditions of some cancer patients are often so serious that there is not the time necessary for effective treatment with conventional drugs. The source of negative emotions is the awareness of the fact that the end of the patient's life is unstoppably approaching - and there is no time left for time-consuming conventional therapies. In addition, the onset of action of traditional antidepressants varies. They can take a number of weeks to be effective and their effectiveness is limited in many cases.

The implementation of the study on cancer patients will bring an existential dimension to palliative medicine, which is only marginally addressed in the current procedures.

The therapeutic effect of psychedelics consists of the temporary induction of an expanded state of consciousness, in which we assume the initiation of a long-term change in ways of thinking and behaviour. The available knowledge very well indicates that the administration of psilocybin in a safe therapeutic environment leads to a rapid and long-term improvement of depressive moods and anxiety, a rediscovery of life balance, and a reduction of existential distress.Thanks to psychedelic-assisted psychotherapy, the patient is able to have a completely new outlook on life. They often discover hidden, deep emotions within themselves, and experience a change in their perception of importance of interpersonal relationships. Therefore, the therapy is extremely fascinating both personally and professionally, not only because of the rapidity of the effect and the minimum of unwanted side-effects, but also because of the personal factor typical for this treatment method. In addition, both psilocybin and ketamine offer a very rapid onset of positive effects after a single administration.

Unique Czech research with a global reach

Thee two currently ongoing Czech scientific studies aim to answer the question of what the mechanism of psilocybin is, how fast and long is its antidepressant effect, and how the effects of the treatment differ compared to ketamine. The international uniqueness of both studies lies in the fact that they compare two psychedelic substances.

In the case of the study of depressed patients, researchers will use modern recording of brain activity using EEG and functional magnetic resonance imaging (fMRI) to further study the mechanisms by which these substances induce an antidepressant effect. In addition, both studies are focused on people for whom, given the circumstances, psychedelics may really be the only hope for a cure, or at least they may mediate the alleviation of depression symptoms. In many cases, the health condition of some patients is so serious that they no longer have the time necessary for effective treatment with conventional drugs. In this context, the implementation of both studies has a clear ambition: to introduce an existential dimension into palliative medicine, which is only marginally addressed in the current procedures.

The PSIKET scientific project covers two different studies that have a similar protocol; however, they are focused on patients with different diagnoses.

The study, called PSIKET001, is evaluating the effect of psychedelics in people with depression who have been failed by conventional treatment. PSIKET002 focuses on the effect of psychedelics-assisted psychotherapy on cancer patients suffering from existential distress. Considering the importance of both areas, it can be assumed that the results of these studies will significantly contribute to the expansion of the portfolio of available treatment approaches for depressed patients as well as to the overall improvement of the treatment of cancer patients with depression.

A promise to people with depression unresponsive to conventional medication

The guarantor and implementer of the PSIKET001 project is Dr Tomáš Páleníček, Ph.D. and his team from the National Institute of Mental Health. This project was approved by the Ethics Committee in the summer of 2021 and supported by a grant from the Health Research Agency of the Ministry of Health of the Czech Republic, which enabled the start of the study, although it does not financially cover the entire project sufficiently.

There is a lack of additional funding to pay the salaries of doctors and researchers. In total, this is a sum of 7 million CZK, which must be covered in the next 4 years. This means a total of less than 2 million CZK per year - and raising these funds is one of the important goals of the PSYRES Foundation. Each, even seemingly small, amount that you decide to donate will therefore help bring the entire project to a successful finale.At the same time, patients are being recruited who must meet the strict criteria necessary to be included in the research:

  • diagnosis
  • age over 18 years
  • resistance to common antidepressants

A total of 60 people will be included in the study and all substances will be administered to them by trained personnel in a safe environment and in combination with psychotherapy. The duration of the project is estimated for a span of 4 years. The initial assumption is that the psychedelics will have a very rapid onset of effect after a single administration, with a minimum of side effects. The project will serve to collect information about the direct effect of substances on the brain. With this information, it will be possible to consult with professional companies about further possible uses of these substances in therapy.

Relief for depressed patients with cancer

The guarantor and implementer of the second part of the project is Prof. Jiří Horáček, Ph.D., FCMA and his team from the National Institute of Mental Health. In 2021, the research was approved by the State Institute for Drug Control and the Ethics Committee. A network of cooperating oncology and palliative care centers was created, which will refer patients to the study, and important study insurance was secured. The actual implementation of the research began in 2022. The launch of the project was also supported by Abakus, the endowment fund of Avast's founders.

Patient recruitment is currently underway. A total of 60 people will gradually be included in the study, with data collection to be completed at the end of 2024. The results of the study will be published in 2025. All substances are (as in the previous part of the project) applied by trained personnel in a safe environment and in combination with psychotherapy.

The clinical evaluations of the project are mainly focused on the study of the antidepressant effect of psilocybin in the population of people with depression, which sometimes accompanies patients with oncological diseases. The effect of psilocybin will be compared to a control substance with antidepressant effect (ketamine) and without antidepressant effect (midazolam).

The costs of the study depend on the price of the realization of the complete protocol for 60 patients. The total price of the data collection corresponds to approximately 15 million CZK. When additional costs are included (insurance, purchase of drugs and their storage, sampling, and data processing), the financial costs of the study will correspond to approximately 20 million CZK. With the support of Abakus, the endowment fund of the founders of Avast worth 1 million CZK, the preparatory work for the start of the study has already begun.

The further continuation of the study is completely dependent on support from private sources - mainly through the fundraising of The PSYRES Foundation. You can also be one of our supporters!