The Swedish Medical Products Agency and Ethical Review Authority have approved the first clinical trial investigating psilocybin-assisted psychotherapy for depression in the European nation, which will be conducted at the Karolinska Institute and funded by the Osmond Foundation and Norrsken Foundation.
- Focus: psilocybin-assisted psychotherapy for depression
- Host: Karolinska Institute, Stockholm, Sweden
- Funding: Osmond Foundation and Norrsken Foundation
- Phase: 2b
- Methodology: randomized, double-blind, placebo-controlled; patients to receive either one dose of psilocybin, or placebo; therapeutic support for five weeks upon dosing.
- Participants: 30
The randomized, placebo-controlled, double-blind phase 2b study seeks to reveal the efficacy of psilocybin-assisted psychotherapy for the treatment of depression. Patients are given one dose of psilocybin, or a placebo, plus 5 weeks of therapeutic support.
“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,” said Johan Lundberg, principal investigator.
Due to the fact that the Osmond Foundation adheres to Open Science protocols, we should expect to see a great deal of transparency around methodology and results. The Foundation also collaborates with the Usona Institute, who is sponsoring a Phase 2 psilocybin for major depressive disorder study in the United States. Usona is supplying the psilocybin for Osmond’s study.
Lundberg explained: “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.”
The study will be hosted at the Karolinska Institute, a research-led medical university in Stockholm, and is funded by the Osmond Foundation and the Norrsken Foundation: both of which are non-profits. The Osmond Foundation has a specific focus on psychedelic medicine, and seeks to unveil the treatment potential of such substances via clinical trials.
In terms of timelines, the clinical trial is set to recruit patients this month, October 2020. We will be following developments closely.