Study design and procedures
C-SSRS
BLOOD
Eligible participants entered the screening period and attended the clinic weekly for three weeks prior to the psilocybin administration session. During this time, eligibility and safety assessments took place including monitoring of medication changes, suicidality (C-SSRS), electrocardiograms (ECGs), blood tests, and vital signs.Preparation for the psilocybin experience was conducted by a therapist who was trained by the sponsor through a specially devised program [The administration session (Day 1) consisted of a single administration of psilocybin 25 mg which could be administered to up to six participants in different rooms simultaneously. Each participant was accompanied by a lead therapist, with whom they had completed preparation, for the six- to eight-hour session to ensure physical and psychological safety and encourage the participant to remain attentive to the natural unfolding of their subjective experience, while avoiding active guidance. An assisting therapist was available within the vicinity to step in at any time if the lead therapist needed to leave or additional support was required, and a study psychiatrist was on site. Blood pressure was monitored continuously using a finger cuff device. If simultaneous administration took place, the lead therapist remained with the participant and one assisting therapist was available by moving between rooms. Participants wore eyeshades and headphones with a specifically designed playlist of music to assist in directing their attention internally. Participants returned home after the acute drug effects had passed.Participants were followed up for three weeks to monitor safety and efficacy. At Day 2 and Week 1 following administration, participants completed an integration session with their lead therapist who encouraged them to derive their own solutions and insights from the psilocybin experience.