30
Participants
Start Date
February 5, 2024
Primary Completion Date
November 19, 2024
Study Completion Date
January 9, 2025
Psilocybin therapy
"Two administrations of psilocybin given 3 weeks apart. The treatment day will begin around 9 a.m. with a brief interview. Patients will be invited to relax and music will be played through speakers and headphones.~One 25 mg capsule of Psilocybin will be given approximately 30 minutes to 1.5 hours later.~The patient is accompanied throughout the session (minimum 6 hours depending on the effects felt). The patient will benefit from a preparation session the day before dosing, and an integration session the day after. Intensive relapse prevention program will be dispensed between the 2 dosing sessions (treatment as usual)."
Inactive Psilocybin therapy
"Two administrations of psilocybin given 3 weeks apart. The treatment day will begin around 9 a.m. with a brief interview. Patients will be invited to relax and music will be played through speakers and headphones.~One 1 mg capsule of Psilocybin will be given approximately 30 minutes to 1.5 hours later.~The patient is accompanied throughout the session (minimum 6 hours depending on the effects felt). The patient will benefit from a preparation session the day before dosing, and an integration session the day after. Intensive relapse prevention program will be dispensed between the 2 dosing sessions (treatment as usual)."
Electroencephalogram
"* Rest EEG prior to first treatment administration~* EEG during first treatment administration~* Rest EEG during integration session after second treatment administration"
Blood samples for the analysis of immune and inflammatory profiles
Three 7ml EDTA tubes will be taken in the morning on an empty stomach at day 0 and at 3 weeks.
stool samples
Stool sampling at day 0 and 3 weeks Analysis of intestinal microbiota is carried out on a stool sample, which is stored at -20°C for a maximum of 24 hours. The sample is then transferred cold to the CRB of the Nîmes University Hospital, where it is stored at -80°C until the microbiology laboratory can perform a group analysis.
MRI functional and cerebral
MRI functional and cerebral at day 0 and 3 weeks
CHU, Nîmes
Centre Hospitalier Universitaire de Nīmes
OTHER