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.

Trial Details

This study aims to evaluate the safety, feasibility, and neurological aspects of psilocybin-assisted psychotherapy for hospitalized patients with treatment-resistant depression (TRD). Patients admitted to Ghent University Hospital undergo screening and are hospitalized for 8 weeks, receiving psilocybin-supported psychotherapy alongside standard treatment. This includes preparatory, psilocybin treatment, and integration phases, with sessions conducted by trained therapists. After hospitalization, patients have weekly outpatient follow-ups for 12 weeks post-treatment and may opt for a year-long observational follow-up. Throughout the study, patients and their partners participate in various assessments, questionnaires, and sessions, with video recordings and EEGs also conducted. The involvement of partners in the study is significant, with their participation in assessments and sessions, including the option to stay overnight during psilocybin sessions. Semi-structured interviews at the beginning and end of the hospitalization phase assess both patient and partner experiences and expectations.

Trial Number NCT06378229

Data attribution

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