The first Swedish clinical trial investigating psilocybin-assisted psychotherapy for depression is announced today, following approval from the Swedish Medical Products Agency and Ethical Review Authority. The study is led by researchers at the Karolinska Institute and is financed by donations from Osmond Foundation, a non-profit dedicated to clinical research on the treatment potential of psychedelic substances, and Norrsken Foundation. Recruitment of patients is expected to begin October 2020.
The study, which is the first of its kind in Sweden, aims to evaluate the clinical effect of psilocybin-assisted psychotherapy on depression and to further understand the mechanisms of the treatment. The trial is a randomized, double-blind, placebo-controlled phase 2b study with 30 patients. Patients will receive either one dose of psilocybin or placebo, with therapeutic support for five weeks.
“Our society lacks effective treatments for many psychiatric disorders, including depression, which severely affects public health on a global scale. With this study, we will investigate a novel treatment approach for depression, and learn more about acute and long-term efficacy. In addition, we will gain further insight into how psilocybin exerts its effect by using brain imaging techniques,” says Johan Lundberg, associate professor at the department of clinical neuroscience at Karolinska Institutet and principal investigator for the study.
More than 260 million people suffer from depression globally and it is the leading cause of disability worldwide today, according to WHO (8). The Swedish Public Health Agency reports that 1 in 5 swedes have been diagnosed with depression (9). Currently available antidepressant medications are effective for some, but studies show that more than 40% of patients do not experience effective alleviation of depression symptoms after trying multiple treatment regimes (10).
”A previous study without a control group indicates that two doses of psilocybin, administered in a clinical environment with therapeutic support, can provide a rapid and relatively long-lasting alleviation of depression compared to existing drugs. These results need to be confirmed through randomized placebo-controlled studies, which is why we have chosen to conduct this trial,” says Johan Lundberg.
“Mental illness is one of the greatest challenges of our time. We have to explore all paths to tackle this problem. Investing in research is essential for progress. The societal benefits associated with developing more effective treatment methods for depression and other mental health disorders are massive. This study takes an innovative approach to a field in desperate need of development,” says Niklas Adalberth, founder of Norrsken Foundation and board member of Osmond Foundation.
“The pharmaceutical industry has shown very limited interest in psilocybin despite positive results from clinical trials. There are no strong financial incentives to invest in a known substance with limited patent options, especially when the treatment regimen studied only involves 1-2 doses. Therefore, it is important that Osmond Foundation can support this research to develop better treatment options for depression,” says Ulf Bremberg, board member of Osmond Foundation and CEO of Osmond Labs, a pharmaceutical company that is fully owned by Osmond Foundation.
Osmond Foundation conducts research under Open Science principles. This means that all methods and results, regardless of the outcome, will be made accessible to other researchers with the purpose of advancing the scientific understanding of psychedelic substances.
Osmond Foundation collaborates with the U.S.-based non-profit organization Usona Institute, which is supplying the GMP investigational drug for this trial. Usona Institute is currently sponsoring a Phase 2 multi-site study with psilocybin for major depressive disorder in the U.S.
For more information, please visit www.osmond-foundation.org or contact email@example.com