Open-Label Phase 1b Study of Oral Psilocybin for Adults With Psychiatric Symptoms Causing Functional Impairment

What this Trial Is About

Researchers are studying the safety, feasibility, and tolerability of psilocybin treatment for people who have difficulties in daily functioning due to psychiatric symptoms such as mood, anxiety, trauma, addiction, or related issues. This Phase 1b proof-of-concept trial includes individuals with various diagnoses and comorbidities to better reflect real-world clinical settings. The study aims to also observe symptom reduction and functional improvements up to six weeks after treatment. Participants will receive a single 25 mg oral dose of psilocybin in a gelatin capsule accompanied by supportive care before, during, and after the dosing session. The trial is open-label with no placebo or blinding and includes follow-up visits at one, four, and six weeks after dosing. There is also an optional long-term follow-up at three, six, and twelve months to reassess participants. During the study, participants will undergo various assessments including interviews, questionnaires, and safety monitoring such as vital signs and adverse event logs. The main safety measures focus on suicide risk and adverse events over six weeks. Secondary measures include functional status and multiple psychiatric symptom scales. Participants will be followed closely with daily diaries and various psychological questionnaires to evaluate changes over time, with the total participation lasting up to 12 months for those in the long-term follow-up.

Open-Label Psilocybin Study in Transdiagnostic Population