Psilocybin-Assisted Psychotherapy for Treatment-Resistant Depression: A Randomized Phase II Clinical Trial Comparing One Versus Two Psychedelic Doses of Psilocybin (PSI-1V2)
The purpose of this study is to see if one or two doses of psilocybin is more effective in relieving depressive symptoms in patients with treatment-resistant depression (TRD). Researchers also want to know if a second dose of psilocybin is safe and well-tolerated. This study will see if psilocybin is effective, safe, and well-tolerated by tracking changes in depressive symptoms, suicidality, and side effects. This study will also see if a second dose of psilocybin has an effect on quality of life, functioning, cognition (thinking, reasoning, remembering), and how long depressive symptoms improve (or worsen) after psilocybin is administered.
- Status
- active
- Phase
- Phase 2
- Institution
- University Health Network, Toronto
- Principal investigator
- Joshua Rosenblat, MD, MSc
- Start date
- 2024-02-05
- End date
- 2026-12-28
- Registry ID
- NCT06341426
Tracked by the DMT Code Clinical Trials Observatory, an open record of DMT-related clinical research.