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.
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