NCT06378229

Psilocybin for Hospitalized Patients with Treatment-resistant Depression

Psilocybin-assisted Psychotherapy in the Treatment of Patients Hospitalized for Treatment-resistant Depression: an Open-label Feasibility Study with an Experiential and Systemic Focus

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: University Hospital, Ghent · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the safety and feasibility of performing psilocybin-assisted psychotherapy in patients hospitalized for treatment-resistant depression.

Detailed description

The proposed study will assess the safety, feasibility, preliminary results and neurological aspects of psilocybin-assisted psychotherapy in the treatment of hospitalized patients with treatment-resistant depression. Screening, after signing the ICF, is done in patients newly admitted to the psychiatric service of Ghent University Hospital or patients referred for hospitalization through the outpatient clinic of the psychiatric service of Ghent University Hospital. Involved patients are hospitalized at the Anxiety, Compulsion and Mood Unit for 8 weeks. They will receive add-on treatment with psilocybin-supported psychotherapy in addition to standard treatment (daily group therapies, mainly non-verbal and activating). This consists of a preparatory phase (4 sessions of 1.5 hours before the first psilocybin session and 1 session of 1.5 hours before the second psilocybin session), the psilocybin sessions themselves (2 sessions, week 3 and week 6) and an integration phase (3 sessions of 1.5 hours after each psilocybin session). All sessions occur with the same 2 therapists throughout the entire course. Therapists are trained to provide experiential and systemic psychotherapeutic interventions. After hospitalization, weekly outpatient follow-up consultations continue until 12 weeks after the last psilocybin session. Subsequently, patients may still agree to a prospective, observational and naturalistic follow-up until 1 year after the last psilocybin session, during which they will be called monthly by a psychiatrist from the research team to inquire about current mental status and any therapies undertaken in the interim. During the study, patients are required to fill out questionnaires at regular intervals. Video-recordings will be made of certain parts of the preparation and integration sessions, for analysis with the client experience scale (EXP). The morning of each psilocybin session, female patients must provide a blood sample for a pregnancy test. The morning of each psilocybin session, all patients must provide a urine sample for toxicology screening. EEGs are also taken from patients the day before each psilocybin session, the morning of the first integration session after each psilocybin session and 12 weeks after the last psilocybin session (at the last outpatient consultation). At the start and at the end of the hospitalization phase, a semi-structured interview will be conducted with the patient to gauge expectations on the one hand and experiences on the other. Throughout the study, the patient's partner will be involved. The partner must complete a number of questionnaires at baseline and throughout the study and will have to be present at 3 EEGs. In addition, the partner will also participate in 1 preparatory session and 2 integration sessions. The partner will also be given the opportunity to spend the night of a psilocybin session with the patient in the hospital (rooming-in). At the start and at the end of the hospitalization phase, a semi-structured interview will be conducted with the partner to gauge expectations on the one hand and experiences on the other.

Conditions

• Treatment Resistant Depression

Interventions

Type	Name	Description
DRUG	Psilocybin	A psychedelic drug found in certain mushrooms. It will be in a capsule of 25mg psilocybin (PEX010).

Timeline

• Start date: 2024-05-21
• Primary completion: 2026-03-01
• Completion: 2026-12-31
• First posted: 2024-04-22
• Last updated: 2024-09-19

Locations

1 site across 1 country: Belgium