Poland allocates €4 million for clinical trial of psilocybin for treatment-resistant depression

The Medical Research Agency of Poland has announced plans to allocate nearly €4 million for a clinical trial using psilocybin to treat treatment-resistant depression (TRD). Pending regulatory approval, this innovative trial to be conducted by the Medical University of Warsaw, will be one of the first globally to explore how selective serotonin reuptake inhibitors (SSRIs) impact the effectiveness and tolerability of psilocybin treatment for depression.

The study will consist of two parts: the first will explore whether adding psilocybin, combined with targeted psychotherapy, can improve outcomes for patients continuing SSRIs; the second will investigate the effects of discontinuing SSRIs on the safety and efficacy of psilocybin therapy. Participants will be randomly assigned to one of two arms in each part, either receiving standard of care (e.g. SSRIs, regular psychotherapy) or two psilocybin doses, preceded by preparation sessions and each followed by integration sessions.

If approvals, namely from the European Medicines Agency (EMA), proceed as planned, patient recruitment for the trial is expected to begin in approximately one year.

This study represents an important step forward for Poland in contributing to global advancements in psychedelic research and mental health care.