Psilocybin for Hospitalized Patients With Treatment-resistant Depression (PSIHOS-D)

This open-label feasibility trial (n=100) aims to assess the safety and feasibility of psilocybin-assisted psychotherapy for hospitalized patients with treatment-resistant depression (TRD).

Patients, admitted to Ghent University Hospital’s psychiatric service, undergo preparatory, psilocybin treatment, and integration phases alongside standard therapy. Weekly outpatient follow-ups continue post-hospitalization, with prospective, observational follow-up up to a year. Both patients and their partners participate in various assessments and sessions throughout the study, aiming to evaluate treatment acceptability and outcomes.

The primary outcome measures include the incidence of adverse events and changes in suicidal ideation, with secondary measures focusing on feasibility, depressive symptoms, quality of life, and therapeutic alliance.

Conducted in Belgium, the study is expected to begin in April 2024 and conclude by December 2026.

Topic Treatment-Resistant Depression Depression Safety
Compound Psilocybin
Country Belgium
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