Norrsken Mind is co-funding a planned randomized, double-blind, placebo-controlled trial at the University of Copenhagen (UCPH) to evaluate the short- and long-term effects of psilocybin for depression when administered within a psychotherapeutic framework versus a medical support model. The study will involve 120 patients and is led by Dea Siggaard Stenbæk, Associate Professor at UCPH, in collaboration with Maria Beckman, Senior researcher at Karolinska Institutet. 

Depression is one of the leading causes of disability globally, with many patients failing to respond to conventional treatments. Previous clinical trials have shown that psilocybin, when combined with psychotherapy, is a promising novel treatment for depression, even in treatment resistant cases. However, there’s a critical gap in scientific knowledge regarding a range of psychotherapeutic factors and their possible contributions for safe and efficacious administration of psilocybin.

The psilocybin setting trial (PSISET) will compare the acute and long-term effects of the psychotherapeutic framing in psilocybin therapy. The study will include 120 patients aged 25-70 years with moderate to severe depression. Participants will be randomized to receive a 25 mg dose of psilocybin or placebo within one of four support models: 1) Psychotherapeutic support with music 2) Psychotherapeutic support without music, and 3) Medical support with music, and 4) Medical support without music. 

This study is a collaboration between University of Copenhagen (UCPH) and Karolinska Institutet. The clinical trial is planned to begin in 2025 and will be conducted at the Copenhagen Clinic for Psychedelic Research (NOESIS) at UCPH in Denmark.

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